CAPECITABINE for Rectal cancer|Locally advanced rectal carcinoma

Inclusion criteria

• {"criterion_text":"- Patient with tumoral regression ≥ 60% and CRM ≥ 1mm,\n- No unequivocal evidence on CT-Scan of established metastatic disease\n- General condition considered suitable for radical pelvic surgery and a systemic therapy with Capecitabine\n- Adequate hematologic, hepatic, renal and ionogram function assessed within 7 days prior to study treatment"}

Exclusion criteria

• {"criterion_text":"- Patient with a history of pelvic radiotherapy,\n- Contraindication to chemotherapy and/or radiotherapy,\n- Complete or partial Dihydropyrimidine deshydrogenase (DPD) deficiency (uracilemia ≥ 16 ng/mL),\n- Known hypersensitivity to Capecitabine drug, study drug classes, or any constituent of the products,\n- Pregnant or breastfeeding woman. If a patient is of childbearing age, she must have a negative pregnancy test (serum β-hCG) documented 72 hours prior to inclusion,\n- Patient treated with an investigational drug within the last 30 days,"}

Primary endpoints

• {"endpoint_text":"- Phase II : The primary endpoint is the R0 resection rate (R0 is a Circumferential resection margin (CRM) ≥1 mm).\n- Phase III: The primary endpoint is the 3 year-DFS.","definition_or_measurement_approach":"Phase II: R0 resection rate where R0 is defined as a Circumferential resection margin (CRM) ≥ 1 mm. Phase III: 3-year disease-free survival (3-year DFS) defined as the time interval from the date of randomization until the date of the first cancer-related event, or death from any cause; patients alive without event are censored at date of last follow-up."}

Secondary endpoints

• {"endpoint_text":"- The compliance rate of the therapeutic schedule\n- Sphincter saving surgery rate\n- Pathological complete response rate\n- Dworak Grading\n- Rates of TME grading (Quirke)\n- Distal margin (DM)\n- Neoadjuvant rectal Score\n- 2-3 year Local recurrence rate using the time to local recurrence (TLR) defined as the time interval from the date of randomization to the date of local recurrence. Patients without local recurrence will be censored at the date of last follow-up or death.\n- 2-3 year Metastasis recurrence rate using the time to metastasis defined as the time interval from the date of randomization to the date of metastasis. Patients without metastasis will be censored at the date of last follow-up or death.\n- 3-year local recurrence free survival rate (L-RFS) defined as the time interval from the date of randomization to the date of local recurrence or death from any cause). Patients alive without local recurrence will be censored at the date of last follow-up.\n- 3-year metastasis recurrence free survival rate (M-RFS defined as the time interval from the date of randomization to the date of metastatic recurrence or death from any cause). Patients alive without metastasis will be censored at the date of last follow-up.\n- 3-year disease free survival rate (DFS) defined as the time interval from the date of randomization until the date of the first cancer-related event, or death from any cause). Patients alive without event will be censored at the date of last follow-up.\n- 3 and 5-year Overall survival (OS) defined as the time interval from the date of randomization to the date of death from any cause. Patients alive will be censored at the date of last follow-up.\n- Safety of neoadjuvant chemotherapy and radiochemotherapy will be evaluated using the NCI-CTCAE version 5.0 scale until the end of the post legal surgery period.\n- Operative morbidity: Clavien-Dindo score (3 & 4), definitive stoma rate, second surgery rate, rehospitalization rate.\n- Digestive: LARS syndrome (randomization, post-surgery, 4, , and 12 months after surgery,\n- Urinary and sexual function evaluated by questionnaires at randomization, post-surgery, 4 and 12 months after surgery\n- Quality of life evaluated by the EORTC QLQ-C30 + CR29 questionnaires (randomization, post-surgery, 4 and 12 months after surgery)","definition_or_measurement_approach":"Where provided in protocol: Local recurrence and metastasis recurrence endpoints use time-to-event definitions from date of randomization to recurrence or metastasis with censoring at last follow-up or death. L-RFS, M-RFS and DFS definitions: time-to-event from randomization to local recurrence/metastatic recurrence/first cancer-related event or death; patients without event censored at last follow-up. Overall survival: time from randomization to death from any cause, censored at last follow-up. Safety assessed using NCI-CTCAE v5.0. Operative morbidity measured by Clavien-Dindo score and reported rates (definitive stoma, reoperation, rehospitalization). QoL assessed by EORTC QLQ-C30 + CR29; urinary/sexual function and LARS by questionnaires at specified timepoints."}

France

Earliest CTIS Part Ii Submission Date

12-03-2024

Latest Decision Or Authorization Date

27-02-2025

Processing Time Days

352

Number Of Sites

30

Number Of Participants

430

Primary sponsor

Full Name

Institut Regional Du Cancer De Montpellier

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

France