Non Inferiority Study of Preoperative Chemotherapy Without Pelvic Irradiation for Rectal Cancer
Recruiting
Phase 3
Interventional Study
Rectal Cancer
Advanced Cancer
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 18 and older
- Sex
- Any
- Trial phase
- Phase 3
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 540 (estimated)
- Sponsor
- Assistance Publique - Hôpitaux de Paris · Other
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About This Trial
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…
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
* Histologically proven middle or low rectal carcinoma, ≤ 10 cm from the anal verge on MRI (sagittal slide)
* cT3N0 and/or cT1-T3N+ on pretreatment imaging work up (pelvic contrast enhanced MRI and/or endorectal ultrasound),
* Pretreatment predictive circumferential margin \> 2m…
Contacts