Induction Chemotherapy Followed by Short Course Radiotherapy in Rectal Cancer

Induction Chemotherapy With FOLFIRINOX ( 5 Fluorouracil, Oxaliplatine and Irinotecan) Followed by Short Course Radiotherapy in Locally Advanced Rectal Cancer

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

Total neoadjuvant treatment (TNT) is currently the standard of care in the management of locally advanced rectal cancer since recent studies have shown improved pathological complete response and disease-free survival with this approach. However, survival benefits remain unproven.

Two strategies of TNT are validated so far : induction chemotherapy with FOLFIRINOX followed by long course radio-chemotherapy (RCT) or short course RT (5x5 Gy) followed by consolidation chemotherapy with CAPOX (capecitabine and oxaliplatin) or FOLFOX (5 FU and oxaliplatin) .

The objective of investigators is to evaluate pathological complete response with a new strategy of TNT consisting in induction chemotherapy with FOLFIRINOXm followed by short course RT and a delayed surgery.

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