Induction Chemotherapy With FOLFIRINOX ( 5 Fluorouracil, Oxaliplatine and Irinotecan) Followed by Short Course Radiotherapy in Locally Advanced Rectal Cancer
Overview
- Phase
- Phase 2
- Intervention
- Chemotherapy With FOLFIRINOX ( 5 Fluorouracil, Oxaliplatine and Irinotecan)
- Conditions
- Rectal Cancer
- Sponsor
- Salah Azaïz Cancer Institute
- Enrollment
- 70
- Locations
- 1
- Primary Endpoint
- Pathologic complete response
- Status
- Active, not recruiting
- Last Updated
- 2 years ago
Overview
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.
Investigators
Amel Mezlini
Professor in Medical Oncology
Salah Azaïz Cancer Institute
Eligibility 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
Arms & Interventions
Induction CT followed by short course RT
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.
Intervention: Chemotherapy With FOLFIRINOX ( 5 Fluorouracil, Oxaliplatine and Irinotecan)
Induction CT followed by short course RT
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.
Intervention: Radiotherapy
Outcomes
Primary Outcomes
Pathologic complete response
Time Frame: 1 month after surgery
no tumor identified in the rectum or associated lymph nodes by final pathology following surgical resection
Secondary Outcomes
- Disease free survival(3 years)
- overall survival(3 years)
- objective response rate to induction chemotherapy(immediately after completion of 6 cycles of chemotherapy ( each cycle is 14 days))