NCT02287727

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

(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

• Status: Withdrawn
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Roswell Park Cancer Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Rectal Adenocarcinoma
• Stage IIA Rectal Cancer
• Stage IIB Rectal Cancer
• Stage IIC Rectal Cancer
• Stage IIIA Rectal Cancer
• Stage IIIB Rectal Cancer

Interventions

Type	Name	Description
OTHER	Laboratory Biomarker Analysis	Correlative studies
DRUG	Regorafenib	Given PO

Timeline

• Start date: 2015-03-01
• Primary completion: 2016-10-01
• First posted: 2014-11-11
• Last updated: 2016-10-12

Locations

3 sites across 1 country: United States