Status:
COMPLETED
Concurrent Chemoradiation + 5-FU + Mitomycin-C in Anal Carcinoma
Lead Sponsor:
Massachusetts General Hospital
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Carcinoma of the Anal Canal
Eligibility:
All Genders
18+ years
Phase:
EARLY_PHASE1
Brief Summary
This research study is a Pilot Study. Pilot studies are conducted to see if it is practical to do this type of research ona larger scale in the future. The pilot part of the study is to assess the pos...
Detailed Description
If you agree to participate in this study, you will be asked to undergo some screening tests or procedures to confirm that you are eligible. Many of these tests and procedures are likely to be part of...
Eligibility Criteria
Inclusion
- Histologically or cytologically confirmed invasive primary squamous, basaloid or cloacogenic carcinoma of the anal canal
- Life expectancy of at least 3 months
Exclusion
- Prior abdominopelvic radiotherapy
- Prior systemic therapy for anal cancer
- Pregnant or breastfeeding
- Receiving other investigational agents
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to mitomycin-C or 5-fluorouracil
- Prior surgery for cancer of the anus that removed all macroscopic anal cancer
- Uncontrolled intercurrent illness
- AIDS based on current CDC definition
- Other immunocompromised status
- Individuals with a history of a different malignancy are ineligible except for the following circumstances: disease-free for at least 5 years or at low risk for recurrence or cervical cancer in situ, and basal cell or squamous cell carcinoma of the skin
Key Trial Info
Start Date :
July 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2021
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT01858025
Start Date
July 1 2013
End Date
November 1 2021
Last Update
September 5 2025
Active Locations (2)
Enter a location and click search to find clinical trials sorted by distance.
1
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
2
Roberts Proton Therapy Center of the University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104