CAPECITABINE for Early-stage rectal cancer

Inclusion criteria

• {"criterion_text":"- Biopsy proven adenocarcinoma of the rectum"}
• {"criterion_text":"- Early- or early-intermediate stage rectal cancer, defined as Magnetic Resonance Imaging (MRI)-T1-3ab, N0/N1 (≤3 mesorectal lymph nodes ≤8mm), MX/M0 rectal tumour"}
• {"criterion_text":"- Tumour located in the distal or mid-rectum for which TME-surgery is required"}
• {"criterion_text":"- Eastern Cooperative Oncology Group (ECOG) performance status 0-1"}
• {"criterion_text":"- Age 18 years or older"}
• {"criterion_text":"- Patient able and willing to provide written informed consent for the study"}

Exclusion criteria

• {"criterion_text":"- Concomitant or previous malignancies within 3 years prior to trial entry, except those that in the opinion of the MDT are unlikely to relapse < 3 years or lead to death < 5 years"}
• {"criterion_text":"- Definite evidence of regional or distant metastases (M1) in opinion of MDT"}
• {"criterion_text":"- Pregnant or lactating women."}
• {"criterion_text":"- Pre-existing faecal incontinence, leading to an expected impaired quality of life post-treatment"}
• {"criterion_text":"- Tumour located in the proximal rectum for which PME-surgery will be sufficient"}
• {"criterion_text":"- MRI suspicious lymph nodes cN1 (1-3 lymph nodes > 8mm) or cN2"}
• {"criterion_text":"- MRI extramural vascular invasion (mriEMVI) present (defined by protocol guidelines)"}
• {"criterion_text":"- MRI defined mucinous tumour"}
• {"criterion_text":"- Mesorectal fascia threatened by tumour (≤ 1mm on MRI)"}
• {"criterion_text":"- Any form of (endoscopic/surgical) local excision of the primary tumour prior to study-entry"}
• {"criterion_text":"- Prior pelvic radiotherapy"}

Primary endpoints

• {"endpoint_text":"- the proportion of patients with successful organ preservation at 24 months from the start of treatment.","definition_or_measurement_approach":"Assessed as the proportion of patients with successful organ preservation at 24 months from the start of treatment."}

Secondary endpoints

• {"endpoint_text":"- Patient- and clinician-reported acute (<3 months following completion of treatment) and late (<1 year following completion of treatment) treatment-related toxicity","definition_or_measurement_approach":"Toxicity reported by patient and clinician; acute defined as <3 months post-treatment completion, late defined as <1 year post-treatment completion."}
• {"endpoint_text":"- Proportion of patients with a clinical complete response at 26 weeks (6 months) after onset of treatment","definition_or_measurement_approach":"Proportion of patients with clinical complete response measured at 26 weeks (6 months) after treatment onset."}
• {"endpoint_text":"- Proportion of patients undergoing transanal local excision","definition_or_measurement_approach":"Proportion measured as number of patients who undergo transanal local excision during study follow-up."}
• {"endpoint_text":"- Complications within the first 30 days after completion or salvage TME-surgery, in terms of postoperatieve morbidity and mortality rates defined by Clavien-Dindo","definition_or_measurement_approach":"Complications recorded within 30 days post-completion or salvage TME-surgery, classified by Clavien-Dindo morbidity and mortality rates."}
• {"endpoint_text":"- Proportion of patients (in each group) with a stoma at 12 months","definition_or_measurement_approach":"Proportion of patients with a stoma assessed at 12 months post-treatment."}
• {"endpoint_text":"- Time to event of organ loss assessed for patients who prefer organ preservation; defined as the length of time from the start date of trial treatment until TME surgery","definition_or_measurement_approach":"Time-to-event endpoint: time from trial treatment start until TME surgery (organ loss) for patients opting for organ preservation."}
• {"endpoint_text":"- Regrowth rate at 36 months; defined as endoluminal or locoregional nodal regrowth detected during W&W follow-up","definition_or_measurement_approach":"Regrowth defined as endoluminal or locoregional nodal regrowth detected during watch-and-wait follow-up; measured to 36 months."}
• {"endpoint_text":"- Metastasis-free survival to 24 months; defined as the length of time from the start date of trial treatment until death (any cause) or detection of distant metastasis","definition_or_measurement_approach":"Metastasis-free survival measured from treatment start to death (any cause) or detection of distant metastasis up to 24 months."}
• {"endpoint_text":"- Non-regrowth-disease free survival to 24 months; defined as the length of time from the start of trial treatment until death (any cause), detection of local pelvic recurrence or distant metastasis but not including patients who developed local regrowth which was resected with clear margins using standard TME surgery","definition_or_measurement_approach":"Time-to-event: from treatment start until death, local pelvic recurrence or distant metastasis (excluding patients with local regrowth resected with clear margins) up to 24 months."}
• {"endpoint_text":"- Overall survival to 36 months; defined as the length of time from the start date of trial treatment until death (any cause)","definition_or_measurement_approach":"Overall survival measured from treatment start until death (any cause) up to 36 months."}
• {"endpoint_text":"- Health Related Quality of Life (HR QoL) standardly measured by EORTC general and colorectal cancer specific quality of life questionnaire (QLQ‐CR29, QLQ‐C30 and EQ-5D-5L) (baseline and at 6 and 24 months); Decision Regret Scale one-time at 24 monts","definition_or_measurement_approach":"HRQoL measured by QLQ-CR29, QLQ-C30 and EQ-5D-5L at baseline, 6 and 24 months; Decision Regret Scale measured once at 24 months."}
• {"endpoint_text":"- Functional outcome: bowel, bladder and sexual dysfunction measured by low anterior resection syndrome (LARS) score, The International Consultation on Incontinence Modular Questionnaire on Male Lower Urinary Tract Symptoms (ICIQ‐ MLUTS)/ ICIQ‐Female Lower Urinary Tract Symptoms (ICIQ‐FLUTS) questionnaires (baseline and at 6 and 24 months)","definition_or_measurement_approach":"Functional outcomes assessed using LARS score, ICIQ-MLUTS and ICIQ-FLUTS questionnaires at baseline, 6 and 24 months."}

Netherlands

Earliest CTIS Part Ii Submission Date

18-07-2024

Latest Decision Or Authorization Date

07-05-2025

Processing Time Days

293

Number Of Sites

22

Number Of Participants

210

Primary sponsor

Full Name

Radboud universitair medisch centrum Stichting

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Netherlands

Third parties

• {"country":"Netherlands","full_name":"Het Nederlands Kanker Instituut-Antoni van Leeuwenhoek Ziekenhuis Stichting","duties_or_roles":"Submission to EC via CTIS. Collect documents from participating sites for EC","organisation_type":"Hospital/Clinic/Other health care facility"}