Study of IMRT Radiotherapy Concurrent Chemothrerapy for Anal Cancer

Chinese Academy of Medical Sciences & Peking Union Medical College

Status and phase: Unknown; Phase 2

Conditions: Anal Cancer

Treatments: Drug: Mitomycin C; Radiation: Chemo-radiotherapy with IMRT technique; Drug: Capecitabine

Study type: Interventional

Funder types: Other

Identifiers

NCT03381352

Y-MX2015-014

Details and patient eligibility

About

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.

Enrollment: 27 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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27 participants in 1 patient group

Chemo-radiotherapy with IMRT technique

Experimental group

Description:

Radiotherapy with IMRT technique concurrent with Capecitabine and MMC chemotherapy

Treatment:

Drug: Capecitabine

Radiation: Chemo-radiotherapy with IMRT technique

Drug: Mitomycin C