Induction Chemotherapy Followed by Short Course Radiotherapy in Rectal Cancer

Salah Azaïz Cancer Institute70 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Rectal Cancer Locally Advanced

Interventions

Chemotherapy With FOLFIRINOX ( 5 Fluorouracil, Oxaliplatine and Irinotecan)DRUG

Induction chemotherapy with six cycles of modified 5 fluorouracil,oxaliplatin and irinotecan followed by short course radiotherapy (RT) (5x5 Gy), then two cycles of 5 fluorouracil and oxaliplatin based chemotherapy and surgery will be performed 6 to 8 weeks after completion of RT. After surgery , continuation of chemotherapy with 4 cycles of 5 fluorouracil and oxaliplatin regardless of pathological response

RadiotherapyRADIATION

Short Course Radiotherapy

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

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

Locations (1)

Amel Mezlini

Tunis, Tunisia

Outcomes

Primary Outcomes

Pathologic complete response

no tumor identified in the rectum or associated lymph nodes by final pathology following surgical resection

Time frame: 1 month after surgery

Secondary Outcomes

Disease free survival

first relapse after surgery

Time frame: 3 years

overall survival

death

Time frame: 3 years

objective response rate to induction chemotherapy

Time frame: immediately after completion of 6 cycles of chemotherapy ( each cycle is 14 days)

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.