NCT01898104

Preoperative Valproic Acid and Radiation Therapy for Rectal Cancer

Phase 1/2 Study of Valproic Acid and Short-course Radiotherapy Plus Capecitabine as preoperatIve Treatment in Low-moderate Risk Rectal Cancer

• Status: Unknown
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 152 (estimated)
• Sponsor: National Cancer Institute, Naples · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to first determine the maximum tolerated dose of capecitabine given alone or in combination with valproic acid during preoperative short-course radiotherapy (Phase 1). The next part of the study (Phase 2)will explore whether the addition of valproic acid or the addition of capecitabine to short-course radiotherapy, before optimal radical surgery might increase the pathologic complete tumor regression rate in patients with low-moderate risk rectal cancer.

Conditions

• Colorectal Cancer

Interventions

Type	Name	Description
RADIATION	preoperative radiation therapy	25 Gy in 5 fractions over 1 week
DRUG	Valproic Acid
DRUG	Capecitabine

Timeline

• Start date: 2012-05-01
• Primary completion: 2023-11-01
• Completion: 2024-04-01
• First posted: 2013-07-12
• Last updated: 2023-03-24

Locations

1 site across 1 country: Italy