Induction Chemotherapy Followed by Short Course Radiotherapy in Rectal Cancer

• Status: Active, not recruiting
• Trial end date: 2023-11-30
• Target enrollment: 0
• Participant gender: All

Summary

A Single-arm phase II trial evaluating induction chemotherapy with FOLFIRINOXm followed by short course radiotherapy (RT) in locally advanced rectal carcinoma

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Salah Azaïz Cancer Institute
• Treatments: Fluorouracil; Folfirinox; Irinotecan; Oxaliplatin

Criteria

Inclusion Criteria:

• World Health Organization (WHO) performance status : 0 or 1

• Histologically proven rectal adenocarcinoma < 10 cm from anal margin on rectoscopy

• clinically T3 (cT3) or clinically T4 (cT4) and/ or N+ non metastatic rectal cancer

• Neutrophil count > 1500 e/mm3

• Platelet count >100000

• Hemoglobin > 10 g/dl ( transfusion allowed)

• Normal bilirubin level

• Creatinine clearance > 50 ml/mn

Exclusion Criteria:

• Distant metastases

• History of chemotherapy or radiotherapy

• Grade 1 neuropathy

• Patient undergoing treatment for another cancer

• Active infection or severe comorbidities contraindicating chemotherapy