Study of IMRT Radiotherapy Concurrent Chemothrerapy for Anal Cancer

Overview

The purpose of this study is to evaluate the efficacy and adverse events of intensity modulated radiation therapy (IMRT) concurrent with chemotherapy for anal squamous carcinoma. All enrolled anal squamous carcinoma patients are intented to receive IMRT concurrent with Capecitabine + mitomycin ± cetuximab targeted therapy.

Full Title of Study: “Phase II Study of IMRT Radiotherapy Concurrent Chemothrerapy for Anal Cancer”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: December 31, 2018

Interventions

  • Radiation: Chemo-radiotherapy with IMRT technique
    • IMRT radiation technique; 50.4-54Gy/25F
  • Drug: Capecitabine
    • Capecitabine 825mg/m2 PO BID
  • Drug: Mitomycin C
    • Mitomycin C 10mg/m2 D1,29 iv

Arms, Groups and Cohorts

  • Experimental: Chemo-radiotherapy with IMRT technique
    • Radiotherapy with IMRT technique concurrent with Capecitabine and MMC chemotherapy

Clinical Trial Outcome Measures

Primary Measures

  • Response rate
    • Time Frame: 8 weeks after IMRT
    • To evaluate response rate of IMRT with chemotherapy

Secondary Measures

  • Adverse events
    • Time Frame: from start of IMRT to 8 weeks after IMRT
    • To assess the adverse events of IMRT with chemotherapy

Participating in This Clinical Trial

Inclusion Criteria

  • CT/MRI diagnosed stage cT1-4N0-3; – Histologically confirmed anal squamous carcinoma; – KPS >= 70 – Adequate organ function; – No previous radiotherapy or chemotherapy; – No surgery. Exclusion Criteria:

  • Previous malignant cancer history; – Allegic to 5-fu or MMC

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 70 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Chinese Academy of Medical Sciences
  • Provider of Information About this Clinical Study
    • Principal Investigator: LI Ning, Principal Investigator – Chinese Academy of Medical Sciences
  • Overall Contact(s)
    • Ning Li, MD, 0086-13810381399, lee_ak@163.com

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