Other Clinical Trial - Phase I Study of Cetuximab in Combination With

Clinical Trial 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

Interventional studies are often prospective and are specifically tailored to evaluate direct impacts of treatment or preventive measures on disease.

Observational studies are often retrospective and are used to assess potential causation in exposure-outcome relationships and therefore influence preventive methods.

Expanded access is a means by which manufacturers make investigational new drugs available, under certain circumstances, to treat a patient(s) with a serious disease or condition who cannot participate in a controlled clinical trial.

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

NCT number	NCT01621217
Study type	Interventional
Source	Lund University Hospital
Contact
Status	Completed
Phase	Phase 1
Start date	June 2012
Completion date	January 2020

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 — NOAC8

Clinical Trial Summary

Clinical Trial Description

Study Design

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