Study of IMRT Radiotherapy Concurrent Chemothrerapy for Anal Cancer

January 28, 2018 updated by: LI Ning, Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Phase II Study of IMRT Radiotherapy Concurrent Chemothrerapy for Anal Cancer

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

27

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Ning Li, MD
  • Phone Number: 0086-13810381399
  • Email: lee_ak@163.com

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100021
        • Recruiting
        • Chinese Academy of Medical Sciences
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Chemo-radiotherapy with IMRT technique
Radiotherapy with IMRT technique concurrent with Capecitabine and MMC chemotherapy
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Response rate
Time Frame: 8 weeks after IMRT
To evaluate response rate of IMRT with chemotherapy
8 weeks after IMRT

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 2, 2015

Primary Completion (Anticipated)

December 31, 2018

Study Completion (Anticipated)

December 31, 2020

Study Registration Dates

First Submitted

December 13, 2017

First Submitted That Met QC Criteria

December 17, 2017

First Posted (Actual)

December 22, 2017

Study Record Updates

Last Update Posted (Actual)

January 30, 2018

Last Update Submitted That Met QC Criteria

January 28, 2018

Last Verified

January 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Y-MX2015-014

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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