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Study of IMRT Radiotherapy Concurrent Chemothrerapy for Anal Cancer

Phase 2
Conditions
Anal Cancer
Interventions
Radiation: Chemo-radiotherapy with IMRT technique
Registration Number
NCT03381352
Lead Sponsor
Chinese Academy of Medical Sciences
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.

Detailed Description

Not available

Recruitment & Eligibility

Status
UNKNOWN
Sex
All
Target Recruitment
27
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

Study & Design

Study Type
INTERVENTIONAL
Study Design
SINGLE_GROUP
Arm && Interventions
GroupInterventionDescription
Chemo-radiotherapy with IMRT techniqueChemo-radiotherapy with IMRT techniqueRadiotherapy with IMRT technique concurrent with Capecitabine and MMC chemotherapy
Chemo-radiotherapy with IMRT techniqueMitomycin CRadiotherapy with IMRT technique concurrent with Capecitabine and MMC chemotherapy
Chemo-radiotherapy with IMRT techniqueCapecitabineRadiotherapy with IMRT technique concurrent with Capecitabine and MMC chemotherapy
Primary Outcome Measures
NameTimeMethod
Response rate8 weeks after IMRT

To evaluate response rate of IMRT with chemotherapy

Secondary Outcome Measures
NameTimeMethod
Adverse eventsfrom start of IMRT to 8 weeks after IMRT

To assess the adverse events of IMRT with chemotherapy

Trial Locations

Locations (1)

Chinese academy of medical sciences

🇨🇳

Beijing, Beijing, China

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