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A phase II study of concurrent chemoradiotherapy with 5-fluorouracil and mitomycin-C for squamous cell carcinoma of the anal canal

A phase II study of concurrent chemoradiotherapy with 5-fluorouracil and mitomycin-C for squamous cell carcinoma of the anal canal - A phase II study of concurrent chemoradiotherapy with 5-fluorouracil and mitomycin-C for squamous cell carcinoma of the anal canal

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000012184
Enrollment
40
Registered
2013-11-01
Start date
2013-11-01
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

squamous cell carcinoma of the anal canal

Interventions

Chemoradiotherapy

Sponsors

Japanese Radiation Oncology Study Group
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1) Histologically diagnosed squamous cell carcinoma of anal canal 2) TNM(7th Version) T1-4N0-3M0 3) ECOG PS 0-1 4) Age between 20 and 80 5) Fit for chemotherapy 6) No prior treatment for anal canal cancer 7) No prior history of pelvic radiation therapy 8) Written informed consent

Exclusion criteria

Exclusion criteria: 1) Other active cancer 2) Severe active co-morbidity such as severe heart disease, uncontrolled DM, and severe infection 3) Women who are or would be pregnant or who are lactating 4) Anti-HIV Ab positive 5) HBs Ag positive 6) Patient who the physician in charge judged unsuitable

Design outcomes

Primary

MeasureTime frame
2-year disease-free survival

Countries

Japan

Contacts

Public ContactKatsuyuki Karasawa

Tokyo Metropolitan Komagome Hospital Department of Radiology

karasawa@cick.jp03-3823-2101

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026