drugset / Trial / NCT03702985
Radiation-protection Effect of Amifostine in Locally Advanced Rectal Cancer
RandomizedParallel-groupOpen-labelPrevention
Summary
The study evaluates the addition of Amifostine to capecitabine and irinotecan in neoadjuvant chemoradiation(CRT) in locally advanced rectal cancer. Half of participants will receive capecitabine and along with neoadjuvant radiotherapy, followed by a cycle of XELIRI, while the others will receive capecitabine and irinotecan added by amifostine 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 it will depends which regimens the patient would receive according to his or her pathological results.
Timeline
- Start
- 2018-05-28
- Primary completion
- 2019-11-01
- Completion
- 2020-03-01
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | amifostine | Unknown | 400 mg/m2 | — |
| Background | Capecitabine | Small molecule | 625 mg/m2 | — |
| Background | Irinotecan | Small molecule | 65 mg/m2 | — |
| Background | Irinotecan | Small molecule | 80 mg/m2 | — |
Indications
No indication recorded.