Study of IMRT Radiotherapy Concurrent Chemothrerapy for Anal Cancer

NCT ID: NCT03381352

Last Updated: 2018-01-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

27 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-12-02

Study Completion Date

2020-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Anal Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Chemo-radiotherapy with IMRT technique

Radiotherapy with IMRT technique concurrent with Capecitabine and MMC chemotherapy

Group Type EXPERIMENTAL

Chemo-radiotherapy with IMRT technique

Intervention Type RADIATION

IMRT radiation technique; 50.4-54Gy/25F

Capecitabine

Intervention Type DRUG

Capecitabine 825mg/m2 PO BID

Mitomycin C

Intervention Type DRUG

Mitomycin C 10mg/m2 D1,29 iv

Interventions

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Chemo-radiotherapy with IMRT technique

IMRT radiation technique; 50.4-54Gy/25F

Intervention Type RADIATION

Capecitabine

Capecitabine 825mg/m2 PO BID

Intervention Type DRUG

Mitomycin C

Mitomycin C 10mg/m2 D1,29 iv

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Chinese Academy of Medical Sciences

OTHER

Sponsor Role lead

Responsible Party

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LI Ning

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Chinese academy of medical sciences

Beijing, Beijing Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Ning Li, MD

Role: CONTACT

0086-13810381399

Facility Contacts

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Ning Li, MD

Role: primary

0086-13810381399

Other Identifiers

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Y-MX2015-014

Identifier Type: -

Identifier Source: org_study_id

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