NCT01621217View on ClinicalTrials.gov

Phase I Study of Cetuximab in Combination With 5-fluoruracil, Mitomycin C and Radiotherapy in Patients With Anal Cancer Stage T2 (>4 cm) - T4 N0-3 M0 or Any T N2-3 M0

PHASE1CompletedINTERVENTIONAL
Enrollment

21

Participants

Timeline

Start Date

June 30, 2012

Primary Completion Date

January 31, 2020

Study Completion Date

January 31, 2020

Conditions
Locally Advanced Cancer in the Anal Region
Interventions
DRUG

Cetuximab

Will be given weekly intravenously during study treatment.

DRUG

Mitomycin C

Will be given intravenously twice together with 5-Fluoruracil during study treatment.

DRUG

5-Fluoruracil

Will be given intravenously twice together with Mitomycin C during study treatment

RADIATION

Radiotherapy

Radiotherapy, once daily with a total dose of 54 Gy, given in 27 fractions.

Trial Locations (3)

4950

University Hospital, Dept. of Oncology, Oslo

221 85

Skåne University Hospital, Dept. of Oncology, Lund

751 85

Accademic Hospital, Dept. of Oncology, Uppsala

All Listed Sponsors
collaborator

Merck Sharp & Dohme LLC

INDUSTRY

lead

Lund University Hospital

OTHER

NCT01621217 - Phase I Study of Cetuximab in Combination With 5-fluoruracil, Mitomycin C and Radiotherapy in Patients With Anal Cancer Stage T2 (>4 cm) - T4 N0-3 M0 or Any T N2-3 M0 | Biotech Hunter | Biotech Hunter