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Metformin With Neoadjuvant Chemoradiation to Improve Pathologic Responses in Rectal Cancer

NCT03053544 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2019-09-27

No results posted yet for this study

Summary

This study is a phase II, single arm, controlled, open label internal pilot.

Conditions

  • Rectal Neoplasm Carcinoma in Situ Adenocarcinoma

Interventions

DRUG

Metformin

Participants will self-administer 500mg metformin twice daily by mouth: 1) beginning 1-2 weeks prior to standard of care CRT, 2) during standard of care CRT and 3) until 30 days after the end of standard of care CRT.

Sponsors & Collaborators

  • Sunnybrook Research Institute

    collaborator OTHER

  • University of Toronto

    collaborator OTHER

  • Sunnybrook Health Sciences Centre

    lead OTHER

Principal Investigators

  • Shun Wong, MD · Sunnybrook Health Sciences Centre

  • Marianne Koritzinsky, MD · Princess Margaret Hospital, Canada

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
19 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-12-08
Primary Completion
2019-06-26
Completion
2019-06-26

Countries

  • Canada

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 NCT03053544 on ClinicalTrials.gov