NCT02526953

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

Randomised Phase III Trial of Chemoradiotherapy With or Without Paclitaxel in Patients With Squamous-cell Anal Cancer

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 314 (estimated)
• Sponsor: Blokhin's Russian Cancer Research Center · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This trial aims to investigate the efficacy of chemoradiotherapy with or without paclitaxel in squamous-cell anal cancer. This is a prospective multicenter open-label randomized phase III clinical trial. Patients will be randomized using an online randomization system to receive either standard IMRT with capecitabine and mitomycin or IMRT with capecitabine, mitomycin and paclitaxel. A stratification will be performed based on T stage, N stage and clinical center. Doses of capecitabine and mitomycin in experimental group were reduced for better treatment tolerance. The target accrual is 157 patients in each treatment arm (including 10% potential data loss) based on potential benefit of 15% 3-yr disease-free survival (70% vs 85%), α=0,05, power 80% in the experimental arm. An interim analysis is planned after 50% of the patients will reach a 3-year followup. Pelvic Magnetic Resonance Imaging (MRI) is performed in all patients for staging and followup. Pelvic MRI and histological diagnosis are subject to central review. Conduction of this study and data collection are controlled by a local institutional board.

Conditions

• Anus Neoplasms
• Carcinoma, Squamous Cell
• Anus Diseases
• Neoplasms
• Neoplasms, Squamous Cell
• Carcinoma

Interventions

Type	Name	Description
DRUG	Paclitaxel	45 mg/m2, IV, weekly during the radiation. Number of infusions: 5.
DRUG	Capecitabine	625 mg/m2, bid, per os, only on days of radiation (Monday through Friday)
DRUG	Capecitabine	825 mg/m2, bid, per os, only on days of radiation (Monday through Friday)
DRUG	Mitomycins	10 mg/m2, IV, on day 1. Number of infusions: 1.
DRUG	Mitomycins	12 mg/m2, IV, on day 1. Number of infusions: 1.
RADIATION	Radiotherapy	Dose: 44 Gy on regional nodes, 52-58 Gy on primary tumor, based on T stage

Timeline

• Start date: 2016-01-01
• Primary completion: 2021-10-01
• Completion: 2022-10-01
• First posted: 2015-08-18
• Last updated: 2021-02-09