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Regorafenib in Reducing Recurrence in Patients With Non-metastatic Rectal Cancer Who Have Completed Curative-Intent Treatment

Rectal Adenocarcinoma Clinical Trial

Official title:
(Bayer Study ONC-2013-036) A Phase II Single-Arm Study of Regorafenib Maintenance Therapy in Patients With T3, T4 or Node-Positive Rectal Cancer Patients Who Completed Curative-Intent Treatment

Clinical Trial Summary

This phase II trial studies how well regorafenib works in reducing the return of disease in patients with rectal cancer that has not spread to another place in the body who have completed curative-intent treatment. Regorafenib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Regorafenib may also help keep cancer from coming back after it has disappeared following the initial therapy.

Clinical Trial Description

PRIMARY OBJECTIVES:

I. To determine the 3-year disease free survival in patients with T3, T4 or node-positive rectal adenocarcinoma who received regorafenib maintenance therapy following the completion of curative-intent standard treatment.

SECONDARY OBJECTIVES:

I. To determine the cumulative incidence of local recurrence, distant recurrence and overall survival at 3 years.

II. To explore for biomarkers associated with anti-cancer effects of regorafenib maintenance therapy in curatively treated rectal cancer patients by analyzing tumor and blood samples.

OUTLINE:

Patients receive regorafenib orally (PO) once daily (QD) on days 1-21. Treatment repeats every 28 days for up to 24 courses in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up at 30 days and then every 4 months for up to 5 years. ;

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02287727
Study type Interventional
Source Roswell Park Cancer Institute
Contact
Status Withdrawn
Phase Phase 2
Start date March 2015
View Details
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