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OpenTrials
Completed

NCT Number: NCT06728982

Impact Of Metformin In Rectal Cancer Patients

Design: Prospective, randomized controlled clinical trial Setting: at Minia University Hospital and Minia Oncology Institute. Condition: Colorectal cancer.

To be eligible for participation, patients must meet the following criteria:

1. Histologically confirmed diagnosis of rectal adenocarcinoma. 2. Age starting from 18 and older. 3. Eastern Cooperative Oncology Group (ECOG) performance status of 0-2. 4. Adequate organ function (renal, hepatic, and hematological) 5. Signed informed consent.

Patients will be randomized into two groups:

Group A: Patients will receive standard chemoradiotherapy(CRT).

Group B: Patients will self-administer 1000mg of metformin twice daily by mouth:

1. beginning 1-2 weeks before standard CRT. 2. during standard CRT. 3. until 30 days after the end of standard CRT.

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Key information

Conditions

Rectal Cancer Patients Disease Attributes Disease Progression Pathologic Complete Response Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Minia Oncology Center, Minya, Egypt

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Histologically confirmed diagnosis of rectal adenocarcinoma.
  • Age starting from 18 and older.
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.
  • Adequate organ function (renal, hepatic, and hematological)
  • Signed informed consent.

Exclusion criteria

  • Metastatic disease.
  • Contraindications to metformin.
  • Significant comorbidities or medical conditions that may interfere with study participation. (D.M, PCO,..)
  • eGFR less than 30 mL/min.
  • Pregnant or breastfeeding women.

Treatment and study plan

metformin

Drug

1000mg of metformin twice daily by mouth

Primary outcomes

  1. Pathological Complete Response (pCR) rate

    Time frame: 6 months

    The Main outcome is to assess the use of metformin to improve pathological complete response (pCR) rates among non-diabetic participants undergoing standard neoadjuvant CRT for rectal cancer.

    The primary outcome will be measured by the pathological complete response rate after completion of the study treatment.

Sponsors and collaborators

Lead sponsor

Minia University

Other

Registry information

Official study title

Metformin Enhances Pathological Complete Response in Non-Diabetic Rectal Cancer Patients Undergoing Neoadjuvant Chemoradiotherapy: A Randomized Controlled Trial

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Dec 11, 2024
Registry last updated
Aug 1, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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