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Study of IMRT Radiotherapy Concurrent Chemothrerapy for Anal Cancer

Primary Purpose

Anal Cancer

Status

Unknown status

Phase

Phase 2

Locations

China

Study Type

Interventional

Intervention

Chemo-radiotherapy with IMRT technique

Capecitabine

Mitomycin C

About this trial

This is an interventional treatment trial for Anal Cancer focused on measuring Radiotherapy, Anal cancer, IMRT

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Chinese academy of medical sciencesRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Chemo-radiotherapy with IMRT technique

Arm Description

Radiotherapy with IMRT technique concurrent with Capecitabine and MMC chemotherapy

Outcomes

Primary Outcome Measures

Response rate

To evaluate response rate of IMRT with chemotherapy

Secondary Outcome Measures

Adverse events

To assess the adverse events of IMRT with chemotherapy

Full Information

NCT ID

NCT03381352

First Posted

December 13, 2017

Last Updated

January 28, 2018

Sponsor

Chinese Academy of Medical Sciences

1. Study Identification

Unique Protocol Identification Number

NCT03381352

Brief Title

Study of IMRT Radiotherapy Concurrent Chemothrerapy for Anal Cancer

Official Title

Phase II Study of IMRT Radiotherapy Concurrent Chemothrerapy for Anal Cancer

Study Type

Interventional

2. Study Status

Record Verification Date

January 2018

Overall Recruitment Status

Unknown status

Study Start Date

December 2, 2015 (Actual)

Primary Completion Date

December 31, 2018 (Anticipated)

Study Completion Date

December 31, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Chinese Academy of Medical Sciences

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Anal Cancer

Keywords

Radiotherapy, Anal cancer, IMRT

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

27 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Chemo-radiotherapy with IMRT technique

Arm Type

Experimental

Arm Description

Radiotherapy with IMRT technique concurrent with Capecitabine and MMC chemotherapy

Intervention Type

Radiation

Intervention Name(s)

Chemo-radiotherapy with IMRT technique

Intervention Description

IMRT radiation technique; 50.4-54Gy/25F

Intervention Type

Drug

Intervention Name(s)

Capecitabine

Intervention Description

Capecitabine 825mg/m2 PO BID

Intervention Type

Drug

Intervention Name(s)

Mitomycin C

Intervention Description

Mitomycin C 10mg/m2 D1,29 iv

Primary Outcome Measure Information:

Title

Response rate

Description

To evaluate response rate of IMRT with chemotherapy

Time Frame

8 weeks after IMRT

Secondary Outcome Measure Information:

Title

Adverse events

Description

To assess the adverse events of IMRT with chemotherapy

Time Frame

from start of IMRT to 8 weeks after IMRT

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility 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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Ning Li, MD

Phone

0086-13810381399

lee_ak@163.com

Facility Information:

Facility Name

Chinese academy of medical sciences

City

Beijing

State/Province

Beijing

ZIP/Postal Code

100021

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Ning Li, MD

Phone

0086-13810381399

lee_ak@163.com

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Study of IMRT Radiotherapy Concurrent Chemothrerapy for Anal Cancer

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