Study of IMRT Radiotherapy Concurrent Chemothrerapy for Anal Cancer

Anal Cancer Clinical Trial

Official title:

Phase II Study of IMRT Radiotherapy Concurrent Chemothrerapy for Anal Cancer

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03381352
• Other study ID #: Y-MX2015-014
• Status: Recruiting
• Phase: Phase 2
• First received: December 13, 2017
• Last updated: January 28, 2018
• Start date: December 2, 2015
• Est. completion date: December 31, 2020

Study information

• Verified date: January 2018
• Source: Chinese Academy of Medical Sciences
• Contact: Ning Li, MD
• Phone: 0086-13810381399
• Email: lee_ak[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 27
• Est. completion date: December 31, 2020
• Est. primary completion date: December 31, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Anal Cancer
• Anus Neoplasms

Intervention

Radiation:
• Chemo-radiotherapy with IMRT technique
IMRT radiation technique; 50.4-54Gy/25F

Drug:
• Capecitabine
Capecitabine 825mg/m2 PO BID
• Mitomycin C
Mitomycin C 10mg/m2 D1,29 iv

Locations

Country	Name	City	State
China	Chinese academy of medical sciences	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Chinese Academy of Medical Sciences

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Response rate	To evaluate response rate of IMRT with chemotherapy	8 weeks after IMRT
Secondary	Adverse events	To assess the adverse events of IMRT with chemotherapy	from start of IMRT to 8 weeks after IMRT