drugset / Trial / NCT02526953

Efficacy Study of Chemoradiotherapy With or Without Paclitaxel in Squamous-cell Anal Carcinoma Patients

NCT02526953

Phase 3 Unknown 314 enrolled Blokhin's Russian Cancer Research Center
RandomizedParallel-groupOpen-labelTreatment

Summary

The purpose of this study is to determine whether the combination of paclitaxel, capecitabine, mitomycin and intensity-modulated radiotherapy is more effective than the standard combination of capecitabine, mitomycin and intensity-modulated radiotherapy (IMRT) in patients with squamous-cell anal cancer.

Timeline

Start
2016-01
Primary completion
2021-10
Completion
2022-10

Drugs

EvaluationDrugModalityDoseRoute
Comparator Capecitabine Small molecule 625 mg/m2 Oral
Comparator Capecitabine Small molecule 825 mg/m2 Oral
Comparator Mitomycin C Other / unclassified 10 mg/m2 Intravenous
Comparator Mitomycin C Other / unclassified 12 mg/m2 Intravenous
Subject Paclitaxel Small molecule 45 mg/m2 Intravenous