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Study of IMRT Radiotherapy Concurrent Chemothrerapy for Anal Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03381352
Recruitment Status : Unknown
Verified January 2018 by LI Ning, Chinese Academy of Medical Sciences.
Recruitment status was:  Recruiting
First Posted : December 22, 2017
Last Update Posted : January 30, 2018
Sponsor:
Information provided by (Responsible Party):
LI Ning, Chinese Academy of Medical Sciences

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Anal Cancer Radiation: Chemo-radiotherapy with IMRT technique Drug: Capecitabine Drug: Mitomycin C Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 27 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Study of IMRT Radiotherapy Concurrent Chemothrerapy for Anal Cancer
Actual Study Start Date : December 2, 2015
Estimated Primary Completion Date : December 31, 2018
Estimated Study Completion Date : December 31, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anal Cancer

Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. Response rate [ Time Frame: 8 weeks after IMRT ]
    To evaluate response rate of IMRT with chemotherapy


Secondary Outcome Measures :
  1. Adverse events [ Time Frame: from start of IMRT to 8 weeks after IMRT ]
    To assess the adverse events of IMRT with chemotherapy


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03381352


Contacts
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Contact: Ning Li, MD 0086-13810381399 lee_ak@163.com

Locations
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China, Beijing
Chinese academy of medical sciences Recruiting
Beijing, Beijing, China, 100021
Contact: Ning Li, MD    0086-13810381399    lee_ak@163.com   
Sponsors and Collaborators
Chinese Academy of Medical Sciences
More Information
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Responsible Party: LI Ning, Principal Investigator, Chinese Academy of Medical Sciences
ClinicalTrials.gov Identifier: NCT03381352    
Other Study ID Numbers: Y-MX2015-014
First Posted: December 22, 2017    Key Record Dates
Last Update Posted: January 30, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Keywords provided by LI Ning, Chinese Academy of Medical Sciences:
Radiotherapy
Anal cancer
IMRT
Additional relevant MeSH terms:
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Anus Neoplasms
Rectal Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Anus Diseases
 Rectal Diseases
Capecitabine
Mitomycins
Mitomycin
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antibiotics, Antineoplastic
Alkylating Agents
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors