Induction Chemotherapy Followed by Short Course Radiotherapy in Rectal Cancer

Phase 2

Active, not recruiting

• Conditions: Rectal Cancer; Locally Advanced
• Interventions: Drug: Chemotherapy With FOLFIRINOX ( 5 Fluorouracil, Oxaliplatine and Irinotecan); Radiation: Radiotherapy

• Registration Number: NCT05868317
• Lead Sponsor: Salah Azaïz Cancer Institute

Brief Summary

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

Detailed Description

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 Timeline

• Study Start: 2020-11-01
• Primary Completion: 2022-11-30
• Study First Submitted: 2023-04-14
• Status Verified: 2023-05
• Study First Submitted QC: 2023-05-19
• Last Update Submitted: 2023-05-19
• Study First Posted: 2023-05-22
• Last Update Posted: 2023-05-22
• Study Completion: 2023-11-30

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 70

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Induction CT followed by short course RT	Chemotherapy With FOLFIRINOX ( 5 Fluorouracil, Oxaliplatine and Irinotecan)	Induction chemotherapy with modified 5 fluorouracil, oxaliplatin and irinotecan followed by short course radiotherapy ( 5x5 Gy), then 5 fluorouracil and oxaliplatin based chemotherapy. Surgery will be performed 6 to 8 weeks after completion of RT.
Induction CT followed by short course RT	Radiotherapy	Induction chemotherapy with modified 5 fluorouracil, oxaliplatin and irinotecan followed by short course radiotherapy ( 5x5 Gy), then 5 fluorouracil and oxaliplatin based chemotherapy. Surgery will be performed 6 to 8 weeks after completion of RT.

Primary Outcome Measures

Name	Time	Method
Pathologic complete response	1 month after surgery	no tumor identified in the rectum or associated lymph nodes by final pathology following surgical resection

Secondary Outcome Measures

Name	Time	Method
Disease free survival	3 years	first relapse after surgery
overall survival	3 years	death
objective response rate to induction chemotherapy	immediately after completion of 6 cycles of chemotherapy ( each cycle is 14 days)

Trial Locations

Locations (1)

Amel Mezlini; 🇹🇳 Tunis, Tunisia