NCT02473094

Neoadjuvant Metformin in Association to Chemoradiotherapy for Locally Advanced Rectal Cancer

Metformin in Association to Chemoradiotherapy for the Neoadjuvant Treatment of Locally Advanced Rectal Cancer: a Randomized, Placebo-controlled Phase II Study

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 3 (actual)
• Sponsor: University of Campinas, Brazil · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

A phase II, randomized study of placebo versus metformin in association to chemotherapy with capecitabine and radiation in the neoadjuvant treatment of locally advanced (T3-4N0M0 or TxN1-2M0) rectal carcinomas.

Detailed description

NEOMETRE is a randomized, double blind trial aiming to evaluate the efficacy and tolerability of metformin in association to chemoradiotherapy for the preoperative treatment of locally advanced (T3-4N0M0 or TxN1-2M0) rectal carcinomas. Patients eligible for this study will be submitted to neoadjuvant 3D radiotherapy with 50,4 Gray (Gy) divided in 25 applications, in association to capecitabine, 825mg/m2 bid for five days every week. The participants will be randomized to daily metformin or placebo during the chemoradiotherapy period. The primary end-point is pathological complete response. The secondary end-points are recurrence-free survival (RFS), disease-free survival (DFS), overall survival (OS), local recurrence rate, overall response rate, sphincter preservation rate, quality of life (QoL) and toxicity.

Conditions

• Rectal Neoplasms
• Adenocarcinoma
• Carcinoma

Interventions

Type	Name	Description
DRUG	Capecitabine	Capecitabine 825mg/m2 bid, D1-D5 q7d
DRUG	Metformin	Metformin up to 2500mg/d
RADIATION	Radiotherapy	3D radiotherapy 50,4Gy divided in 25 fractions
DRUG	Placebo	Placebo up to 2500mg/d

Timeline

• Start date: 2015-07-01
• Primary completion: 2016-02-01
• Completion: 2016-02-01
• First posted: 2015-06-16
• Last updated: 2017-11-28

Locations

1 site across 1 country: Brazil