Phase II Study of IMRT Radiotherapy Concurrent Chemothrerapy for Anal Cancer
Overview
- Phase
- Phase 2
- Intervention
- Chemo-radiotherapy with IMRT technique
- Conditions
- Anal Cancer
- Sponsor
- Chinese Academy of Medical Sciences
- Enrollment
- 27
- Locations
- 1
- Primary Endpoint
- Response rate
- Last Updated
- 8 years ago
Overview
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.
Investigators
LI Ning
Principal Investigator
Chinese Academy of Medical Sciences
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
Arms & Interventions
Chemo-radiotherapy with IMRT technique
Radiotherapy with IMRT technique concurrent with Capecitabine and MMC chemotherapy
Intervention: Chemo-radiotherapy with IMRT technique
Chemo-radiotherapy with IMRT technique
Radiotherapy with IMRT technique concurrent with Capecitabine and MMC chemotherapy
Intervention: Capecitabine
Chemo-radiotherapy with IMRT technique
Radiotherapy with IMRT technique concurrent with Capecitabine and MMC chemotherapy
Intervention: Mitomycin C
Outcomes
Primary Outcomes
Response rate
Time Frame: 8 weeks after IMRT
To evaluate response rate of IMRT with chemotherapy
Secondary Outcomes
- Adverse events(from start of IMRT to 8 weeks after IMRT)