Locally Advanced, Rectal Cancer
Conditions
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.
Interventions
DRUGChemotherapy With FOLFIRINOX ( 5 Fluorouracil, Oxaliplatine and Irinotecan)
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
RADIATIONRadiotherapy
Short Course Radiotherapy
Sponsors
Salah Azaïz Cancer Institute
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pathologic complete response | 1 month after surgery | no tumor identified in the rectum or associated lymph nodes by final pathology following surgical resection |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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) | — |
Countries
Tunisia
Outcome results
None listed