Trials / Completed
CompletedNCT02605265
Trial of Capecitabine With or Without Irinotecan Driven by UGT1A1
A Randomized Phase III Trial of Capecitabine With or Without Irinotecan Driven by UGT1A1 in Neoadjuvant Chemoradiation of Locally Advanced Rectal Cancer
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 356 (actual)
- Sponsor
- Fudan University · Academic / Other
- Sex
- All
- Age
- 18 Years – 75 Years
- Healthy volunteers
- Not accepted
Summary
The study evaluate the addition of Irinotecan in neoadjuvant chemoradiation. Half of participants will receive capecitabine alone together with neoadjuvant CRT, followed by a cycle of XELOX, while the other will receive capecitabine and irinotecan during CRT, followed by a cycle of XELIRI. All participants will be scheduled to receive surgery 6-8 weeks after the completion of CRT, then 5 cycles of adjuvant chemotherapy of XELOX.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| RADIATION | Radiation | Pelvic Radiation: 50Gy/25Fx |
| DRUG | Capecitabine | |
| DRUG | Irinotecan | |
| DRUG | Oxaliplatin |
Timeline
- Start date
- 2015-10-01
- Primary completion
- 2017-12-01
- Completion
- 2023-06-01
- First posted
- 2015-11-16
- Last updated
- 2025-08-28
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT02605265. Inclusion in this directory is not an endorsement.