Neoadjuvant Treatment for Advanced Rectal Carcinoma

• Status: Active, not recruiting
• Trial end date: 2030-08-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of the study is to compare pre-operative radio-chemotherapy (RT + capecitabine) to a short course RT associated with a delayed surgery, with two primary objectives: the efficacy evaluation (rate of R0 resection) and the preservation of autonomy (score IADL).

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: UNICANCER
• Treatments: Capecitabine

Criteria

Inclusion Criteria:

• Patient ≥75 years

• Eastern Cooperative Oncology Group (ECOG) ≤2

• Adenocarcinoma of the rectum histologically proven

• Tumor ≤12 cm from the anal margin, the measurement done by rigid rectoscopy or by sub peritoneal MRI

• Require a pre-operative treatment (tumor classified T3 or T4 resectable by MRI and tomodensitometry or T2 of the very low rectum)

• Patient operable

• No radiologically detectable metastases

• Absolute Neutrophile count (ANC) ≥1500/mm³; Platelets ≥100 000/mm³ and Hemoglobin ≥10 g/dL

• Bilirubin ≤1.5 x upper limit of normal (ULN), aspartate aminotransferase (ASAT) and alanine aminotransferase (ALAT) ≤1.5 x upper limit of normal (ULN), Alkaline Phosphatase ≤1.5 x upper limit of normal (ULN)

• Creatinine clearance ≥30 ml/min (Cockcroft and Gault)

• Public or private Health Insurance coverage

• Patient has been informed and signed the informed consent document

Exclusion Criteria:

• Non-resectable tumor

• History of chronic diarrhea or an inflammatory disease of the colon or rectum, or intestinal obstruction or sub-obstruction

• History of pelvic radiotherapy

• Any active febrile infection or any other serious underlying pathology that may prevent the patient from receiving the treatment

• Significant Cardiovascular diseases such as, but not limited to: cardiovascular or myocardial infarction ≤6 months before inclusion, congestive heart failure class II or higher (NYHA), unstable angina, arrhythmia requiring medication or uncontrolled hypertension;

• Significative cardiovascular conditions such as, but not limited to : Cardiac angioplasty or stenting, Myocardial infarction, Unstable angina, Coronary artery bypass graft surgery Symptomatic peripheral vascular disease, Class III or IV congestive heart failure, as defined by the New York Heart Association (NYHA), clinically significant irregular heartbeat requiring medication

• Severe and unexpected reactions to fluoropyrimidine therapy

• Any contra-indication to capecitabine and its excipients; patients with hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not included.

• Any other concomitant cancer or history of cancer in the last 3 years, with the exception of the in situ cancer of the uterus, treated, or squamous-cell or basal-cell carcinoma.

• Patients already included in another therapeutic trail with an experimental molecule

• Person deprived of liberty

• Patient that for geographical, social and/or physical reasons will not be able to follow the procedure as required by the protocol