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Trial Title:
Induction Chemotherapy Followed by Short Course Radiotherapy in Rectal Cancer
NCT ID:
NCT05868317
Condition:
Rectal Cancer
Locally Advanced
Conditions: Official terms:
Rectal Neoplasms
Fluorouracil
Irinotecan
Folfirinox
Oxaliplatin
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Active, not recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Chemotherapy With FOLFIRINOX ( 5 Fluorouracil, Oxaliplatine and Irinotecan)
Description:
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
Arm group label:
Induction CT followed by short course RT
Intervention type:
Radiation
Intervention name:
Radiotherapy
Description:
Short Course Radiotherapy
Arm group label:
Induction CT followed by short course RT
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.
Criteria for 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
Gender:
All
Minimum age:
18 Years
Maximum age:
70 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Amel Mezlini
Address:
City:
Tunis
Country:
Tunisia
Start date:
November 1, 2020
Completion date:
November 30, 2023
Lead sponsor:
Agency:
Salah Azaïz Cancer Institute
Agency class:
Other
Source:
Salah Azaïz Cancer Institute
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05868317
