MedTrace Logo

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

NCT01621217 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 21

Last updated 2020-02-28

No results posted yet for this study

Summary

* To establish maximum tolerated dose of the two cytotoxic drugs 5-fluoruracil and mitomycin C when given together with the antibody cetuximab in patients with locally advanced cancer in the anal region
* To evaluate acute toxicity
* To evaluate late toxicity
* To evaluate response rate
* To evaluate recurrence free survival
* To evaluate overall survival

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.

Sponsors & Collaborators

Principal Investigators

  • Anders Johnsson, MD, PhD · Skåne University Hospital, Dept. of Oncology

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-06-30
Primary Completion
2020-01-31
Completion
2020-01-31

Countries

  • Norway
  • Sweden

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01621217 on ClinicalTrials.gov