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

Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional

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

Brief 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 Summary: 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.
Sponsor: Blokhin's Russian Cancer Research Center

Current Primary Outcome: 3-year disease-free survival [ Time Frame: 3 years ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Complete response at 26 weeks [ Time Frame: 26 weeks ]
  • 3-year colostomy-free survival [ Time Frame: 3 years ]
  • 3-year cancer-specific survival [ Time Frame: 3 years ]
  • 3-year overall survival [ Time Frame: 3 years ]
  • Acute toxicity measured according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) v.4.0 [ Time Frame: 30 days ]
    Toxicity measured according to NCI-CTCAE v.4.0
  • Late toxicity measured according to Radiation Therapy Oncology Group (RTOG) criteria [ Time Frame: 3 years ]
    Late toxicity measured according to RTOG criteria


Original Secondary Outcome:

  • Complete response at 26 weeks [ Time Frame: 26 weeks ]
  • 3-year colostomy-free survival [ Time Frame: 3 years ]
  • 3-year cancer-specific survival [ Time Frame: 3 years ]
  • 3-year overall survival [ Time Frame: 3 years ]
  • Acute toxicity measured according to NCI-CTC v.4.0 [ Time Frame: 30 days ]
    Toxicity measured according to NCI-CTC v.4.0
  • Late toxicity measured according to RTOG criteria [ Time Frame: 3 years ]
    Late toxicity measured according to RTOG criteria


Information By: Blokhin's Russian Cancer Research Center

Dates:
Date Received: August 15, 2015
Date Started: October 2015
Date Completion: October 2021
Last Updated: August 17, 2015
Last Verified: August 2015