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Neoadjuvant Metformin in Association to Chemoradiotherapy for Locally Advanced Rectal Cancer

NCT02473094 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 3

Last updated 2017-11-28

No results posted yet for this study

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.

Conditions

  • Rectal Neoplasms
  • Adenocarcinoma
  • Carcinoma

Interventions

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

Sponsors & Collaborators

  • University of Campinas, Brazil

    lead OTHER

Principal Investigators

  • Ligia T Macedo, MD · Clinical Oncology Department, State University of Campinas (UNICAMP)

  • Jose BC Carvalheira, MD, PhD · Clinical Oncology Department, State University of Campinas (UNICAMP)

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-07-31
Primary Completion
2016-02-29
Completion
2016-02-29

Countries

  • Brazil

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02473094 on ClinicalTrials.gov