Clinical Trial Intelligence

Which endpoints dominate European Phase II and III colorectal cancer trials?

9 July 2026

Across 189 unique European CTIS Phase II and III colorectal cancer trials, safety/adverse event endpoints were the most frequently measured endpoint family, appearing in 147 trials (77.8%). Overall survival followed in 130 trials (68.8%), progression-free survival in 102 trials (54.0%), and objective response in 87 trials (46.0%). Phase II leaned toward safety and response-driven endpoint packages, while Phase III shifted toward survival, disease-free/relapse-free survival, and quality-of-life outcomes.

Most common endpoint
147
Safety / AEs in 147/189 trials (77.8%)
Top survival endpoint
130
Overall survival in 130/189 trials (68.8%)
Phase II cohort
128
Safety/AEs in 108/128 trials (84.4%)
Phase III cohort
68
OS in 47/68 trials (69.1%)

Which endpoints are measured most often overall?

Safety/adverse events, overall survival, progression-free survival, and objective response form the dominant endpoint core. Together, these four endpoint families appeared in 87 to 147 of the 189 included trials.

Endpoint family frequency, any endpoint role
Safety / AEs77.8%
Overall survival68.8%
Progression-free survival54.0%
Objective response46.0%
Quality of life / PRO38.1%
Imaging / diagnostics32.3%
DOR30.2%
DFS / RFS27.5%
Percent of 189 European Phase II/III colorectal cancer trials measuring each endpoint family in primary, secondary, or exploratory content.
Interpretation

The European colorectal CTIS endpoint pattern is not response-only: safety, OS, and PFS dominate the measurable evidence package, while ORR remains common but ranks fourth overall.

How do endpoint priorities differ by primary, secondary, and exploratory role?

Primary endpoints were recorded in 177/189 trials (93.7%), secondary endpoints in 157/189 trials (83.1%), and exploratory/other endpoints in 6/189 trials (3.2%). As primary endpoints, safety/AEs led with 52 trials (27.5%), followed by ORR in 44 (23.3%) and PFS in 38 (20.1%).

Top endpoint families by role
Role #1 #2 #3
Primary Safety/AEs
52/189 · 27.5%		 ORR
44/189 · 23.3%		 PFS
38/189 · 20.1%
Secondary Safety/AEs
122/189 · 64.6%		 OS
119/189 · 63.0%		 PFS
80/189 · 42.3%
Exploratory / other Biomarker / ctDNA / MRD
4/189 · 2.1%		 OS
3/189 · 1.6%		 Safety/AEs
3/189 · 1.6%
Endpoint families counted once per trial per endpoint role.
Interpretation

Primary endpoints concentrate on early efficacy and tolerability signals, while secondary endpoint packages carry the broader registrational evidence layer: safety, OS, PFS, QoL/PRO, ORR, and DOR.

What changes between Phase II and Phase III?

The Phase II cohort included 128 trials and the Phase III cohort included 68 trials. Phase II most often measured safety/AEs (108/128, 84.4%), OS (89/128, 69.5%), PFS (75/128, 58.6%), and ORR (68/128, 53.1%). Phase III most often measured OS (47/68, 69.1%), safety/AEs (45/68, 66.2%), QoL/PRO (32/68, 47.1%), and PFS (29/68, 42.6%).

Endpoint frequency by phase cohort
Endpoint Phase II Phase III
Safety / AEs84.4%66.2%
OS69.5%69.1%
PFS58.6%42.6%
ORR / response53.1%30.9%
QoL / PRO34.4%47.1%
DFS / RFSlower than top 1036.8%
Phase II/III trials are counted in both relevant phase cohorts for phase-specific percentages.
Interpretation

Phase II colorectal trials retain a response-and-safety signal-finding profile, while Phase III adds stronger patient-centered and long-horizon outcomes: QoL/PRO appears in 32/68 Phase III trials (47.1%) and DFS/RFS in 25/68 (36.8%).

Which disease and sub-disease groups drive different endpoint choices?

Advanced, metastatic, locally advanced, or unresectable CRC labels appeared in 107/189 trials (56.6%). Molecularly defined CRC appeared in 41/189 trials (21.7%), rectal/rectal adenocarcinoma in 34/189 (18.0%), colon/colon adenocarcinoma in 19/189 (10.1%), and localized/adjuvant CRC in 17/189 (9.0%).

Endpoint leaders by CRC subgroup
Subgroup Most frequent endpoint families
Advanced/metastatic/unresectable CRC
107 trials		 Safety/AEs 85/107 (79.4%); OS 82/107 (76.6%); PFS 75/107 (70.1%); ORR 68/107 (63.6%)
Molecularly defined CRC
41 trials		 Safety/AEs 34/41 (82.9%); PFS 29/41 (70.7%); OS 28/41 (68.3%); ORR 25/41 (61.0%)
Rectal / rectal adenocarcinoma
34 trials		 DFS/RFS 24/34 (70.6%); Safety/AEs 24/34 (70.6%); OS 22/34 (64.7%); pathologic response 21/34 (61.8%)
Colon / colon adenocarcinoma
19 trials		 DFS/RFS 18/19 (94.7%); Safety/AEs 15/19 (78.9%); OS 13/19 (68.4%); QoL/PRO 7/19 (36.8%)
Localized / adjuvant CRC
{"id":"822c3a5b-3bd5-4314-aa91-7489a92bfea9","slug":"eu-colorectal-phase-2-3-endpoints","status":"published","title":"Which endpoints dominate European Phase II and III colorectal cancer trials?","html":"\u003c!--\n\"slug\": \"eu-colorectal-phase-2-3-endpoints\",\n\"metaTitle\": \"EU Colorectal Phase II/III Endpoint Trends\",\n\"title\": \"Which endpoints dominate European Phase II and III colorectal cancer trials?\",\n\"metaDescription\": \"Safety/AEs led 147/189 trials; OS 130 and PFS 102. Phase II favored ORR/safety primaries, Phase III shifted to PFS/DFS.\",\n\"keywords\": \"European colorectal cancer trials, Phase II colorectal endpoints, Phase III colorectal endpoints, CTIS colorectal cancer, progression-free survival, overall survival, objective response rate, colorectal cancer safety endpoints, metastatic colorectal cancer, ctDNA MRD colorectal cancer\"\n-->\n\n\u003cdiv style=\"background:#111315; color:#F2F2F2; font-family:Inter, ui-sans-serif, system-ui, -apple-system, BlinkMacSystemFont, 'Segoe UI', sans-serif; padding:48px 24px 72px 24px;\">\n\u003cdiv style=\"max-width:768px; margin:0 auto;\">\n\n\u003csection style=\"background:linear-gradient(180deg,#122319 0%,#111315 100%); border:1px solid rgba(255,255,255,0.10); border-radius:8px; padding:32px; margin-bottom:64px;\">\n\n\u003cdiv style=\"font-size:12px; font-weight:650; color:#3FAE6F; text-transform:uppercase; letter-spacing:0.08em; margin-bottom:16px;\">\nClinical Trial Intelligence\n\u003c/div>\n\n\u003cdiv class=\"section-header-container\" data-export-section-header=\"true\" data-section-title=\"Which endpoints dominate European Phase II and III colorectal cancer trials?\">\n\n\u003ch1 style=\"font-size:48px; line-height:56px; font-weight:650; letter-spacing:-0.035em; margin:0 0 12px 0; color:#F2F2F2;\">\nWhich endpoints dominate European Phase II and III colorectal cancer trials?\n\u003c/h1>\n\n\u003cdiv style=\"font-size:13px; line-height:1.5; font-weight:600; color:#3FAE6F; margin:0 0 22px 0;\">\n9 July 2026\n\u003c/div>\n\n\u003cp style=\"font-size:17px; line-height:1.65; font-weight:400; color:rgba(255,255,255,0.70); margin:0 0 28px 0;\">\nAcross 189 unique European CTIS Phase II and III colorectal cancer trials, safety/adverse event endpoints were the most frequently measured endpoint family, appearing in 147 trials (77.8%). Overall survival followed in 130 trials (68.8%), progression-free survival in 102 trials (54.0%), and objective response in 87 trials (46.0%). Phase II leaned toward safety and response-driven endpoint packages, while Phase III shifted toward survival, disease-free/relapse-free survival, and quality-of-life outcomes.\n\u003c/p>\n\n\u003c/div>\n\n\u003cdiv style=\"display:grid; grid-template-columns:repeat(2,minmax(0,1fr)); gap:14px; margin-top:28px;\">\n \u003cdiv style=\"background:#181B1E; border:1px solid rgba(255,255,255,0.10); border-radius:8px; padding:18px;\">\n \u003cdiv style=\"font-size:12px; color:rgba(255,255,255,0.55); text-transform:uppercase; letter-spacing:0.08em;\">Most common endpoint\u003c/div>\n \u003cdiv style=\"font-size:34px; line-height:1.1; font-weight:650; margin-top:8px; color:#3FAE6F;\">147\u003c/div>\n \u003cdiv style=\"font-size:14px; color:rgba(255,255,255,0.70); margin-top:6px;\">Safety / AEs in 147/189 trials (77.8%)\u003c/div>\n \u003c/div>\n \u003cdiv style=\"background:#181B1E; border:1px solid rgba(255,255,255,0.10); border-radius:8px; padding:18px;\">\n \u003cdiv style=\"font-size:12px; color:rgba(255,255,255,0.55); text-transform:uppercase; letter-spacing:0.08em;\">Top survival endpoint\u003c/div>\n \u003cdiv style=\"font-size:34px; line-height:1.1; font-weight:650; margin-top:8px; color:#3FAE6F;\">130\u003c/div>\n \u003cdiv style=\"font-size:14px; color:rgba(255,255,255,0.70); margin-top:6px;\">Overall survival in 130/189 trials (68.8%)\u003c/div>\n \u003c/div>\n \u003cdiv style=\"background:#181B1E; border:1px solid rgba(255,255,255,0.10); border-radius:8px; padding:18px;\">\n \u003cdiv style=\"font-size:12px; color:rgba(255,255,255,0.55); text-transform:uppercase; letter-spacing:0.08em;\">Phase II cohort\u003c/div>\n \u003cdiv style=\"font-size:34px; line-height:1.1; font-weight:650; margin-top:8px; color:#3FAE6F;\">128\u003c/div>\n \u003cdiv style=\"font-size:14px; color:rgba(255,255,255,0.70); margin-top:6px;\">Safety/AEs in 108/128 trials (84.4%)\u003c/div>\n \u003c/div>\n \u003cdiv style=\"background:#181B1E; border:1px solid rgba(255,255,255,0.10); border-radius:8px; padding:18px;\">\n \u003cdiv style=\"font-size:12px; color:rgba(255,255,255,0.55); text-transform:uppercase; letter-spacing:0.08em;\">Phase III cohort\u003c/div>\n \u003cdiv style=\"font-size:34px; line-height:1.1; font-weight:650; margin-top:8px; color:#3FAE6F;\">68\u003c/div>\n \u003cdiv style=\"font-size:14px; color:rgba(255,255,255,0.70); margin-top:6px;\">OS in 47/68 trials (69.1%)\u003c/div>\n \u003c/div>\n\u003c/div>\n\n\u003c/section>\n\n\u003cdiv style=\"height:1px; background:rgba(255,255,255,0.10); margin:0 0 64px 0;\">\u003c/div>\n\n\u003csection style=\"margin-bottom:64px;\">\n\u003cdiv class=\"section-header-container\" data-export-section-header=\"true\" data-section-title=\"Overall endpoint ranking\">\n\u003ch2 style=\"font-size:30px; line-height:38px; font-weight:620; letter-spacing:-0.02em; color:#F2F2F2; margin:0 0 16px 0;\">\nWhich endpoints are measured most often overall?\n\u003c/h2>\n\u003cp style=\"font-size:17px; line-height:1.65; color:rgba(255,255,255,0.70); margin:0;\">\nSafety/adverse events, overall survival, progression-free survival, and objective response form the dominant endpoint core. Together, these four endpoint families appeared in 87 to 147 of the 189 included trials.\n\u003c/p>\n\u003c/div>\n\n\u003cdiv class=\"chart-container\" data-chart-title=\"Most frequent endpoint families across all included trials\" data-export-chart=\"true\" style=\"background:#181B1E; border:1px solid rgba(255,255,255,0.10); border-radius:8px; padding:24px; margin-top:24px;\">\n\u003cdiv style=\"font-size:12px; font-weight:650; color:rgba(255,255,255,0.55); text-transform:uppercase; letter-spacing:0.08em; margin-bottom:18px;\">\nEndpoint family frequency, any endpoint role\n\u003c/div>\n\n\u003cdiv style=\"display:grid; gap:14px;\">\n \u003cdiv>\u003cdiv style=\"display:flex; justify-content:space-between;\">\u003cspan>Safety / AEs\u003c/span>\u003cspan>77.8%\u003c/span>\u003c/div>\u003cdiv style=\"height:10px; background:#25292D; border-radius:999px;\">\u003cdiv style=\"width:77.8%; height:10px; background:#3FAE6F; border-radius:999px;\">\u003c/div>\u003c/div>\u003c/div>\n \u003cdiv>\u003cdiv style=\"display:flex; justify-content:space-between;\">\u003cspan>Overall survival\u003c/span>\u003cspan>68.8%\u003c/span>\u003c/div>\u003cdiv style=\"height:10px; background:#25292D; border-radius:999px;\">\u003cdiv style=\"width:68.8%; height:10px; background:#3FAE6F; border-radius:999px;\">\u003c/div>\u003c/div>\u003c/div>\n \u003cdiv>\u003cdiv style=\"display:flex; justify-content:space-between;\">\u003cspan>Progression-free survival\u003c/span>\u003cspan>54.0%\u003c/span>\u003c/div>\u003cdiv style=\"height:10px; background:#25292D; border-radius:999px;\">\u003cdiv style=\"width:54.0%; height:10px; background:#3FAE6F; border-radius:999px;\">\u003c/div>\u003c/div>\u003c/div>\n \u003cdiv>\u003cdiv style=\"display:flex; justify-content:space-between;\">\u003cspan>Objective response\u003c/span>\u003cspan>46.0%\u003c/span>\u003c/div>\u003cdiv style=\"height:10px; background:#25292D; border-radius:999px;\">\u003cdiv style=\"width:46.0%; height:10px; background:#3FAE6F; border-radius:999px;\">\u003c/div>\u003c/div>\u003c/div>\n \u003cdiv>\u003cdiv style=\"display:flex; justify-content:space-between;\">\u003cspan>Quality of life / PRO\u003c/span>\u003cspan>38.1%\u003c/span>\u003c/div>\u003cdiv style=\"height:10px; background:#25292D; border-radius:999px;\">\u003cdiv style=\"width:38.1%; height:10px; background:#3FAE6F; border-radius:999px;\">\u003c/div>\u003c/div>\u003c/div>\n \u003cdiv>\u003cdiv style=\"display:flex; justify-content:space-between;\">\u003cspan>Imaging / diagnostics\u003c/span>\u003cspan>32.3%\u003c/span>\u003c/div>\u003cdiv style=\"height:10px; background:#25292D; border-radius:999px;\">\u003cdiv style=\"width:32.3%; height:10px; background:#3FAE6F; border-radius:999px;\">\u003c/div>\u003c/div>\u003c/div>\n \u003cdiv>\u003cdiv style=\"display:flex; justify-content:space-between;\">\u003cspan>DOR\u003c/span>\u003cspan>30.2%\u003c/span>\u003c/div>\u003cdiv style=\"height:10px; background:#25292D; border-radius:999px;\">\u003cdiv style=\"width:30.2%; height:10px; background:#3FAE6F; border-radius:999px;\">\u003c/div>\u003c/div>\u003c/div>\n \u003cdiv>\u003cdiv style=\"display:flex; justify-content:space-between;\">\u003cspan>DFS / RFS\u003c/span>\u003cspan>27.5%\u003c/span>\u003c/div>\u003cdiv style=\"height:10px; background:#25292D; border-radius:999px;\">\u003cdiv style=\"width:27.5%; height:10px; background:#3FAE6F; border-radius:999px;\">\u003c/div>\u003c/div>\u003c/div>\n\u003c/div>\n\n\u003cdiv style=\"border-top:1px solid rgba(255,255,255,0.10); margin-top:20px; padding-top:10px; font-size:11px; color:rgba(255,255,255,0.45); letter-spacing:0.04em;\">\nPercent of 189 European Phase II/III colorectal cancer trials measuring each endpoint family in primary, secondary, or exploratory content.\n\u003c/div>\n\u003c/div>\n\n\u003cdiv class=\"conclusion-container\" data-conclusion-title=\"Overall endpoint ranking\" data-export-conclusion=\"true\" style=\"border-left:3px solid #3FAE6F; background:rgba(63,174,111,0.08); border-radius:8px; padding:18px 20px; margin-top:24px;\">\n\u003cdiv style=\"font-size:12px; font-weight:650; color:#3FAE6F; text-transform:uppercase; letter-spacing:0.08em; margin-bottom:8px;\">Interpretation\u003c/div>\n\u003cp style=\"font-size:17px; line-height:1.65; color:rgba(255,255,255,0.78); margin:0;\">\nThe European colorectal CTIS endpoint pattern is not response-only: safety, OS, and PFS dominate the measurable evidence package, while ORR remains common but ranks fourth overall.\n\u003c/p>\n\u003c/div>\n\u003c/section>\n\n\u003csection style=\"margin-bottom:64px;\">\n\u003cdiv class=\"section-header-container\" data-export-section-header=\"true\" data-section-title=\"Primary, secondary, and exploratory endpoint roles\">\n\u003ch2 style=\"font-size:30px; line-height:38px; font-weight:620; letter-spacing:-0.02em; color:#F2F2F2; margin:0 0 16px 0;\">\nHow do endpoint priorities differ by primary, secondary, and exploratory role?\n\u003c/h2>\n\u003cp style=\"font-size:17px; line-height:1.65; color:rgba(255,255,255,0.70); margin:0;\">\nPrimary endpoints were recorded in 177/189 trials (93.7%), secondary endpoints in 157/189 trials (83.1%), and exploratory/other endpoints in 6/189 trials (3.2%). As primary endpoints, safety/AEs led with 52 trials (27.5%), followed by ORR in 44 (23.3%) and PFS in 38 (20.1%).\n\u003c/p>\n\u003c/div>\n\n\u003cdiv class=\"chart-container\" data-chart-title=\"Endpoint families by endpoint role\" data-export-chart=\"true\" style=\"background:#181B1E; border:1px solid rgba(255,255,255,0.10); border-radius:8px; padding:24px; margin-top:24px;\">\n\u003cdiv style=\"font-size:12px; font-weight:650; color:rgba(255,255,255,0.55); text-transform:uppercase; letter-spacing:0.08em; margin-bottom:18px;\">\nTop endpoint families by role\n\u003c/div>\n\n\u003ctable style=\"width:100%; border-collapse:collapse; font-size:14px; line-height:1.45;\">\n\u003cthead>\n\u003ctr style=\"color:rgba(255,255,255,0.55); text-transform:uppercase; letter-spacing:0.06em; font-size:11px;\">\n\u003cth style=\"text-align:left; padding:0 0 10px 0;\">Role\u003c/th>\n\u003cth style=\"text-align:left; padding:0 0 10px 0;\">#1\u003c/th>\n\u003cth style=\"text-align:left; padding:0 0 10px 0;\">#2\u003c/th>\n\u003cth style=\"text-align:left; padding:0 0 10px 0;\">#3\u003c/th>\n\u003c/tr>\n\u003c/thead>\n\u003ctbody>\n\u003ctr style=\"border-top:1px solid rgba(255,255,255,0.10);\">\n\u003ctd style=\"padding:14px 8px 14px 0; color:#3FAE6F; font-weight:650;\">Primary\u003c/td>\n\u003ctd style=\"padding:14px 8px;\">Safety/AEs\u003cbr>\u003cspan style=\"color:rgba(255,255,255,0.55);\">52/189 · 27.5%\u003c/span>\u003c/td>\n\u003ctd style=\"padding:14px 8px;\">ORR\u003cbr>\u003cspan style=\"color:rgba(255,255,255,0.55);\">44/189 · 23.3%\u003c/span>\u003c/td>\n\u003ctd style=\"padding:14px 0 14px 8px;\">PFS\u003cbr>\u003cspan style=\"color:rgba(255,255,255,0.55);\">38/189 · 20.1%\u003c/span>\u003c/td>\n\u003c/tr>\n\u003ctr style=\"border-top:1px solid rgba(255,255,255,0.10);\">\n\u003ctd style=\"padding:14px 8px 14px 0; color:#3FAE6F; font-weight:650;\">Secondary\u003c/td>\n\u003ctd style=\"padding:14px 8px;\">Safety/AEs\u003cbr>\u003cspan style=\"color:rgba(255,255,255,0.55);\">122/189 · 64.6%\u003c/span>\u003c/td>\n\u003ctd style=\"padding:14px 8px;\">OS\u003cbr>\u003cspan style=\"color:rgba(255,255,255,0.55);\">119/189 · 63.0%\u003c/span>\u003c/td>\n\u003ctd style=\"padding:14px 0 14px 8px;\">PFS\u003cbr>\u003cspan style=\"color:rgba(255,255,255,0.55);\">80/189 · 42.3%\u003c/span>\u003c/td>\n\u003c/tr>\n\u003ctr style=\"border-top:1px solid rgba(255,255,255,0.10);\">\n\u003ctd style=\"padding:14px 8px 14px 0; color:#3FAE6F; font-weight:650;\">Exploratory / other\u003c/td>\n\u003ctd style=\"padding:14px 8px;\">Biomarker / ctDNA / MRD\u003cbr>\u003cspan style=\"color:rgba(255,255,255,0.55);\">4/189 · 2.1%\u003c/span>\u003c/td>\n\u003ctd style=\"padding:14px 8px;\">OS\u003cbr>\u003cspan style=\"color:rgba(255,255,255,0.55);\">3/189 · 1.6%\u003c/span>\u003c/td>\n\u003ctd style=\"padding:14px 0 14px 8px;\">Safety/AEs\u003cbr>\u003cspan style=\"color:rgba(255,255,255,0.55);\">3/189 · 1.6%\u003c/span>\u003c/td>\n\u003c/tr>\n\u003c/tbody>\n\u003c/table>\n\n\u003cdiv style=\"border-top:1px solid rgba(255,255,255,0.10); margin-top:20px; padding-top:10px; font-size:11px; color:rgba(255,255,255,0.45); letter-spacing:0.04em;\">\nEndpoint families counted once per trial per endpoint role.\n\u003c/div>\n\u003c/div>\n\n\u003cdiv class=\"conclusion-container\" data-conclusion-title=\"Primary, secondary, and exploratory endpoint roles\" data-export-conclusion=\"true\" style=\"border-left:3px solid #3FAE6F; background:rgba(63,174,111,0.08); border-radius:8px; padding:18px 20px; margin-top:24px;\">\n\u003cdiv style=\"font-size:12px; font-weight:650; color:#3FAE6F; text-transform:uppercase; letter-spacing:0.08em; margin-bottom:8px;\">Interpretation\u003c/div>\n\u003cp style=\"font-size:17px; line-height:1.65; color:rgba(255,255,255,0.78); margin:0;\">\nPrimary endpoints concentrate on early efficacy and tolerability signals, while secondary endpoint packages carry the broader registrational evidence layer: safety, OS, PFS, QoL/PRO, ORR, and DOR.\n\u003c/p>\n\u003c/div>\n\u003c/section>\n\n\u003csection style=\"margin-bottom:64px;\">\n\u003cdiv class=\"section-header-container\" data-export-section-header=\"true\" data-section-title=\"Phase II versus Phase III endpoint strategy\">\n\u003ch2 style=\"font-size:30px; line-height:38px; font-weight:620; letter-spacing:-0.02em; color:#F2F2F2; margin:0 0 16px 0;\">\nWhat changes between Phase II and Phase III?\n\u003c/h2>\n\u003cp style=\"font-size:17px; line-height:1.65; color:rgba(255,255,255,0.70); margin:0;\">\nThe Phase II cohort included 128 trials and the Phase III cohort included 68 trials. Phase II most often measured safety/AEs (108/128, 84.4%), OS (89/128, 69.5%), PFS (75/128, 58.6%), and ORR (68/128, 53.1%). Phase III most often measured OS (47/68, 69.1%), safety/AEs (45/68, 66.2%), QoL/PRO (32/68, 47.1%), and PFS (29/68, 42.6%).\n\u003c/p>\n\u003c/div>\n\n\u003cdiv class=\"chart-container\" data-chart-title=\"Phase II versus Phase III endpoint profile\" data-export-chart=\"true\" style=\"background:#181B1E; border:1px solid rgba(255,255,255,0.10); border-radius:8px; padding:24px; margin-top:24px;\">\n\u003cdiv style=\"font-size:12px; font-weight:650; color:rgba(255,255,255,0.55); text-transform:uppercase; letter-spacing:0.08em; margin-bottom:18px;\">\nEndpoint frequency by phase cohort\n\u003c/div>\n\n\u003ctable style=\"width:100%; border-collapse:collapse; font-size:14px;\">\n\u003cthead>\n\u003ctr style=\"color:rgba(255,255,255,0.55); text-transform:uppercase; letter-spacing:0.06em; font-size:11px;\">\n\u003cth style=\"text-align:left; padding-bottom:10px;\">Endpoint\u003c/th>\n\u003cth style=\"text-align:right; padding-bottom:10px;\">Phase II\u003c/th>\n\u003cth style=\"text-align:right; padding-bottom:10px;\">Phase III\u003c/th>\n\u003c/tr>\n\u003c/thead>\n\u003ctbody>\n\u003ctr style=\"border-top:1px solid rgba(255,255,255,0.10);\">\u003ctd style=\"padding:12px 0;\">Safety / AEs\u003c/td>\u003ctd style=\"text-align:right;\">84.4%\u003c/td>\u003ctd style=\"text-align:right;\">66.2%\u003c/td>\u003c/tr>\n\u003ctr style=\"border-top:1px solid rgba(255,255,255,0.10);\">\u003ctd style=\"padding:12px 0;\">OS\u003c/td>\u003ctd style=\"text-align:right;\">69.5%\u003c/td>\u003ctd style=\"text-align:right;\">69.1%\u003c/td>\u003c/tr>\n\u003ctr style=\"border-top:1px solid rgba(255,255,255,0.10);\">\u003ctd style=\"padding:12px 0;\">PFS\u003c/td>\u003ctd style=\"text-align:right;\">58.6%\u003c/td>\u003ctd style=\"text-align:right;\">42.6%\u003c/td>\u003c/tr>\n\u003ctr style=\"border-top:1px solid rgba(255,255,255,0.10);\">\u003ctd style=\"padding:12px 0;\">ORR / response\u003c/td>\u003ctd style=\"text-align:right;\">53.1%\u003c/td>\u003ctd style=\"text-align:right;\">30.9%\u003c/td>\u003c/tr>\n\u003ctr style=\"border-top:1px solid rgba(255,255,255,0.10);\">\u003ctd style=\"padding:12px 0;\">QoL / PRO\u003c/td>\u003ctd style=\"text-align:right;\">34.4%\u003c/td>\u003ctd style=\"text-align:right;\">47.1%\u003c/td>\u003c/tr>\n\u003ctr style=\"border-top:1px solid rgba(255,255,255,0.10);\">\u003ctd style=\"padding:12px 0;\">DFS / RFS\u003c/td>\u003ctd style=\"text-align:right;\">lower than top 10\u003c/td>\u003ctd style=\"text-align:right;\">36.8%\u003c/td>\u003c/tr>\n\u003c/tbody>\n\u003c/table>\n\n\u003cdiv style=\"border-top:1px solid rgba(255,255,255,0.10); margin-top:20px; padding-top:10px; font-size:11px; color:rgba(255,255,255,0.45); letter-spacing:0.04em;\">\nPhase II/III trials are counted in both relevant phase cohorts for phase-specific percentages.\n\u003c/div>\n\u003c/div>\n\n\u003cdiv class=\"conclusion-container\" data-conclusion-title=\"Phase II versus Phase III endpoint strategy\" data-export-conclusion=\"true\" style=\"border-left:3px solid #3FAE6F; background:rgba(63,174,111,0.08); border-radius:8px; padding:18px 20px; margin-top:24px;\">\n\u003cdiv style=\"font-size:12px; font-weight:650; color:#3FAE6F; text-transform:uppercase; letter-spacing:0.08em; margin-bottom:8px;\">Interpretation\u003c/div>\n\u003cp style=\"font-size:17px; line-height:1.65; color:rgba(255,255,255,0.78); margin:0;\">\nPhase II colorectal trials retain a response-and-safety signal-finding profile, while Phase III adds stronger patient-centered and long-horizon outcomes: QoL/PRO appears in 32/68 Phase III trials (47.1%) and DFS/RFS in 25/68 (36.8%).\n\u003c/p>\n\u003c/div>\n\u003c/section>\n\n\u003csection style=\"margin-bottom:64px;\">\n\u003cdiv class=\"section-header-container\" data-export-section-header=\"true\" data-section-title=\"Disease and sub-disease patterns\">\n\u003ch2 style=\"font-size:30px; line-height:38px; font-weight:620; letter-spacing:-0.02em; color:#F2F2F2; margin:0 0 16px 0;\">\nWhich disease and sub-disease groups drive different endpoint choices?\n\u003c/h2>\n\u003cp style=\"font-size:17px; line-height:1.65; color:rgba(255,255,255,0.70); margin:0;\">\nAdvanced, metastatic, locally advanced, or unresectable CRC labels appeared in 107/189 trials (56.6%). Molecularly defined CRC appeared in 41/189 trials (21.7%), rectal/rectal adenocarcinoma in 34/189 (18.0%), colon/colon adenocarcinoma in 19/189 (10.1%), and localized/adjuvant CRC in 17/189 (9.0%).\n\u003c/p>\n\u003c/div>\n\n\u003cdiv class=\"chart-container\" data-chart-title=\"Endpoint leaders by disease subgroup\" data-export-chart=\"true\" style=\"background:#181B1E; border:1px solid rgba(255,255,255,0.10); border-radius:8px; padding:24px; margin-top:24px;\">\n\u003cdiv style=\"font-size:12px; font-weight:650; color:rgba(255,255,255,0.55); text-transform:uppercase; letter-spacing:0.08em; margin-bottom:18px;\">\nEndpoint leaders by CRC subgroup\n\u003c/div>\n\n\u003ctable style=\"width:100%; border-collapse:collapse; font-size:14px; line-height:1.45;\">\n\u003cthead>\n\u003ctr style=\"color:rgba(255,255,255,0.55); text-transform:uppercase; letter-spacing:0.06em; font-size:11px;\">\n\u003cth style=\"text-align:left; padding-bottom:10px;\">Subgroup\u003c/th>\n\u003cth style=\"text-align:left; padding-bottom:10px;\">Most frequent endpoint families\u003c/th>\n\u003c/tr>\n\u003c/thead>\n\u003ctbody>\n\u003ctr style=\"border-top:1px solid rgba(255,255,255,0.10);\">\n\u003ctd style=\"padding:14px 12px 14px 0; color:#3FAE6F; font-weight:650;\">Advanced/metastatic/unresectable CRC\u003cbr>\u003cspan style=\"color:rgba(255,255,255,0.55); font-weight:400;\">107 trials\u003c/span>\u003c/td>\n\u003ctd style=\"padding:14px 0;\">Safety/AEs 85/107 (79.4%); OS 82/107 (76.6%); PFS 75/107 (70.1%); ORR 68/107 (63.6%)\u003c/td>\n\u003c/tr>\n\u003ctr style=\"border-top:1px solid rgba(255,255,255,0.10);\">\n\u003ctd style=\"padding:14px 12px 14px 0; color:#3FAE6F; font-weight:650;\">Molecularly defined CRC\u003cbr>\u003cspan style=\"color:rgba(255,255,255,0.55); font-weight:400;\">41 trials\u003c/span>\u003c/td>\n\u003ctd style=\"padding:14px 0;\">Safety/AEs 34/41 (82.9%); PFS 29/41 (70.7%); OS 28/41 (68.3%); ORR 25/41 (61.0%)\u003c/td>\n\u003c/tr>\n\u003ctr style=\"border-top:1px solid rgba(255,255,255,0.10);\">\n\u003ctd style=\"padding:14px 12px 14px 0; color:#3FAE6F; font-weight:650;\">Rectal / rectal adenocarcinoma\u003cbr>\u003cspan style=\"color:rgba(255,255,255,0.55); font-weight:400;\">34 trials\u003c/span>\u003c/td>\n\u003ctd style=\"padding:14px 0;\">DFS/RFS 24/34 (70.6%); Safety/AEs 24/34 (70.6%); OS 22/34 (64.7%); pathologic response 21/34 (61.8%)\u003c/td>\n\u003c/tr>\n\u003ctr style=\"border-top:1px solid rgba(255,255,255,0.10);\">\n\u003ctd style=\"padding:14px 12px 14px 0; color:#3FAE6F; font-weight:650;\">Colon / colon adenocarcinoma\u003cbr>\u003cspan style=\"color:rgba(255,255,255,0.55); font-weight:400;\">19 trials\u003c/span>\u003c/td>\n\u003ctd style=\"padding:14px 0;\">DFS/RFS 18/19 (94.7%); Safety/AEs 15/19 (78.9%); OS 13/19 (68.4%); QoL/PRO 7/19 (36.8%)\u003c/td>\n\u003c/tr>\n\u003ctr style=\"border-top:1px solid rgba(255,255,255,0.10);\">\n\u003ctd style=\"padding:14px 12px 14px 0; color:#3FAE6F; font-weight:650;\">Localized / adjuvant CRC\u003cbr>\u003cspan style=\"colo","excerpt":"Safety/AEs led 147/189 trials; OS 130 and PFS 102. Phase II favored ORR/safety primaries, Phase III shifted to PFS/DFS.","coverImageUrl":null,"coverImageAlt":null,"author":null,"category":null,"tags":[],"metaTitle":"EU Colorectal Phase II/III Endpoint Trends","metaDescription":"Safety/AEs led 147/189 trials; OS 130 and PFS 102. Phase II favored ORR/safety primaries, Phase III shifted to PFS/DFS.","canonicalUrl":null,"robots":"index,follow","keywords":["European colorectal cancer trials","Phase II colorectal endpoints","Phase III colorectal endpoints","CTIS colorectal cancer","progression-free survival","overall survival","objective response rate","colorectal cancer safety endpoints","metastatic colorectal cancer","ctDNA MRD colorectal cancer"],"ogTitle":"EU Colorectal Phase II/III Endpoint Trends","ogDescription":"Safety/AEs led 147/189 trials; OS 130 and PFS 102. Phase II favored ORR/safety primaries, Phase III shifted to PFS/DFS.","ogImageUrl":"https://trialagents.com/og-default.png","ogImageAlt":"Which endpoints dominate European Phase II and III colorectal cancer trials?","ogType":"article","twitterCard":"summary_large_image","twitterTitle":"EU Colorectal Phase II/III Endpoint Trends","twitterDescription":"Safety/AEs led 147/189 trials; OS 130 and PFS 102. Phase II favored ORR/safety primaries, Phase III shifted to PFS/DFS.","twitterImageUrl":"https://trialagents.com/og-default.png","schemaJsonLd":{"@context":"https://schema.org","@graph":[{"@type":"Article","headline":"Which endpoints dominate European Phase II and III colorectal cancer trials?","description":"Safety/AEs led 147/189 trials; OS 130 and PFS 102. Phase II favored ORR/safety primaries, Phase III shifted to PFS/DFS.","datePublished":"2026-07-10","dateModified":"2026-07-10","author":{"@type":"Organization","name":"TrialAgents","url":"https://trialagents.com"},"publisher":{"@type":"Organization","name":"TrialAgents","url":"https://trialagents.com"},"mainEntityOfPage":"https://trialagents.com/reports/eu-colorectal-phase-2-3-endpoints"},{"@type":"Dataset","name":"Which endpoints dominate European Phase II and III colorectal cancer trials?","description":"Safety/AEs led 147/189 trials; OS 130 and PFS 102. Phase II favored ORR/safety primaries, Phase III shifted to PFS/DFS.","variableMeasured":["Most frequent endpoint families across all included trials","Endpoint families by endpoint role","Phase II versus Phase III endpoint profile","Endpoint leaders by disease subgroup"],"spatialCoverage":"Europe","isAccessibleForFree":true,"license":"https://creativecommons.org/licenses/by/4.0/","creator":{"@type":"Organization","name":"TrialAgents","url":"https://trialagents.com"}}]},"publishedAt":"2026-07-10T21:21:37.246Z","createdAt":"2026-07-10T21:21:37.374Z","updatedAt":"2026-07-10T21:21:37.374Z"}