Induction Chemotherapy Followed by Short Course Radiotherapy in Rectal Cancer

Salah Azaïz Cancer Institute

Status and phase: Active, not recruiting; Phase 2

Conditions: Locally Advanced; Rectal Cancer

Treatments: Drug: Chemotherapy With FOLFIRINOX ( 5 Fluorouracil, Oxaliplatine and Irinotecan); Radiation: Radiotherapy

Study type: Interventional

Funder types: Other

Identifiers

NCT05868317

ISANOX

Details and patient eligibility

About

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

Full 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.

Enrollment: 70 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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70 participants in 1 patient group

Induction CT followed by short course RT

Experimental group

Description:

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.

Treatment:

Drug: Chemotherapy With FOLFIRINOX ( 5 Fluorouracil, Oxaliplatine and Irinotecan)

Radiation: Radiotherapy