At a glance
ClinicalIndex Comparison Record- ✓Histologically proven middle or low rectal carcinoma, ≤10 cm from anal verge on MRI
- ✓cT3N0 and/or cT1-T3N+ on pretreatment imaging
- ✓Pretreatment predictive circumferential margin >2mm on pretreatment imaging
- ✓Age 18 years or older
- ✕Rectal tumor >10 cm from anal verge on MRI
- ✕cT4 tumor or involvement of external sphincter
- ✕Circumferential margin ≤2 mm on pretreatment imaging
- ✕Metastatic disease
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Non Inferiority Multicenter Phase III Randomized Trial Comparing Preoperative Chemotherapy Only to Chemotherapy Followed by Chemoradiotherapy for Locally Advanced Resectable Rectal Cancer (Intergroup FRENCH-GRECCAR- PRODIGE)
In Brief
A Phase 3 clinical trial evaluating Chemotherapy and Radiochemotherapy for Rectal Cancer and Advanced Cancer. Currently recruiting, targeting 540 participants across 1 site.
Detailed Summary
This study is a non-inferiority phase III randomised trial comparing preoperative chemotherapy alone (modified FOLFIRINOX) to chemotherapy followed by chemoradiotherapy in patients with primary resectable locally advanced rectal cancer. The primary endpoint of the study is 3-year progression free survival. Expected 3 year PFS rate in the preoperative chemotherapy followed by chemoradiotherapy arm is 75%. This hazard rate, in an exponential survival model, corresponds to a decrease in the 3-year PFS rate on the preoperative chemotherapy arm to 67%. The study will randomize 540 patients (270 in the chemotherapy group and 270 in the chemoradiotherapy group) in 42 french academic centers.
Study Details
Timeline
Interventions
Arm A : Experimental * Intervention Type : Drug * Intervention Name : Modified FOLFIRINOX (experimental arm) * Intervention Description : preoperative chemotherapy: Modified FOLFIRINOX regimen comprised oxaliplatin 85mg/m2 + irinotecan 180mg/m2 + Folinic acid 400 mg/m2 at day1, then 5-FU given as a continuous infusion over 46h every two weeks. Six cycles are planned preoperatively.
Arm B: Active comparator * Intervention Name : modified FOLFIRINOX followed by preoperative standardized radiochemotherapy (control arm) * Intervention Description : preoperative chemotherapy: Modified FOLFIRINOX regimen comprised oxaliplatin 85mg/m2 + irinotecan 180mg/m2 + Folinic acid 400 mg/m2 at day1, then 5-FU given as a continuous infusion over 46h every two weeks. Six cycles are planned preoperatively.followed by preoperative radiochemotherapy with concurrent capecitabine 825 mg/m2/12h 5 days/week and intensity modulated radiation therapy using a simultaneous integrated boost technique with 45 Gy in 25 fractions in pelvic volume and 50 Gy in 25 fractions to the tumor.