Neoadjuvant FOLFOXIRI Versus CapeOX Chemotherapy for Local Advanced Rectal Cancer
Recruiting
Phase 3
Interventional Study
Rectal 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 – 75
- Sex
- Any
- Trial phase
- Phase 3
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 300 (estimated)
- Sponsor
- Fudan University · Other
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About This Trial
This is a phase III randomized controlled trial comparing the efficacy and safety of FOLFOXIRI versus CapeOX as neoadjuvant regimen in treating patients with middle and upper locally advanced (MRI T3-4 or N+) rectal cancer. This study aims to optimize the neoadjuvant therapy for patients with anus-preserving resectable locally advanced rectal cancer, so as to improve the prognosis of them. It rema…
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
* MRI evaluated of T3-4 or N+ rectal cancer;
* Pathologically diagnosed of rectal adenocarcinoma;
* 18 to 75 years old;
* Distance from lower margin of tumor to anus \<15 cm and suitable for anus-preserving resection;
* Tumor amenable to radical resection;
* Treatment-na?ve pati…
Contacts