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Diabetes drug shows promise against rectal cancer in new trial

NCT ID NCT02437656

Disease control Sponsor: Centre Oscar Lambret Source: ClinicalTrials.gov ↗

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study looked at whether adding metformin, a common diabetes medicine, to standard chemo and radiation therapy could help people with locally advanced rectal cancer. 60 adults with stage T3 or T4 rectal cancer took part. The main goal was to see if the combination led to a complete disappearance of cancer cells in the tumor after surgery.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

60 people

The number who actually took part.

Started

May 2015

Finished

Mar 2017

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Patient with an adenocarcinoma of the low or middle rectum. 2. T3 or T4 stage (T evaluated by MRI and / or echo-endoscopy). 3. Absence of distant metastasis. 4. Patient requiring a radiochemotherapy. 5. Correct hematological conditions : Neutrophils ≥ 1500 G / L, platelets ≥ 100 000 G / L. 6. Age ≥ 18 years 7. Performance status (WHO) ≤ 2 8. Lactatemia ≤ Higher standard of the sampling laboratory. 9. For women of childbearing age, a contraceptive method is mandatory for the entire duration of the study. Exclusion Criteria: 1. Other histologies such as squamous cell carcinoma, neuroendocrine tumors, melanomas, etc. 2. History of lactic acidosis. 3. Any diabetes (According to the WHO definition : fasting plasma glucose (FPG) \> 1.26 g / L-1). 4. Ongoing antidiabetic treatment such as * Biguanides, hypoglycemic sulfamides, glinides, GLP-1 analogue, gliptins, alpha-glucosidase inhibitors * Insulin or insulin analogues 5. Hypersensitivity to capecitabine or to any of the excipients or to fluorouracil. 6. History of severe and unexpected reactions to a fluoropyrimidine therapy. 7. Patient with known deficiency to the dihydropyrimidine dehydrogenase (DPD). 8. Hypersensitivity to metformin or to any of the excipients. 9. Renal failure or impaired renal function (creatinine clearance \< 60 ml / min). 10. Severe infection. 11. Acute or chronic disease which may cause tissue hypoxia such as heart or respiratory failure or recent myocardial infarction (\< 6 months). 12. Hepatic insufficiency, acute alcohol intoxication, alcoholism. 13. Psychiatric inability to give consent. 14. Contraindication to radiation therapy and/or chemotherapy. 15. Treatment with sorivudine or its chemically related analogues, such as brivudine. 16. Patient under tutorship or guardianship. 17. Pregnant or breastfeeding women.

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Conditions

The condition(s) this trial relates to.

rectal cancer rectal neoplasm

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Rectal cancer

Contacts and locations

Locations

  • Centre Galilée - Hôpital Privé La Louvière

    Lille, 59045, France

  • Centre Gray

    Maubeuge, 59600, France

  • Centre Hospitalier

    Lens, 62300, France

  • Centre Joliot-Curie

    Saint-Martin-Boulogne, 62200, France

  • Centre Léonard de Vinci - SARL du pont Saint Vaast

    Douai, 59500, France

  • Centre Marie Curie

    Arras, 62000, France

  • Centre Oscar Lambret

    Lille, 59020, France

  • Centre Pierre Curie

    Beuvry, 62880, France

  • Clinique des Dentellières

    Valenciennes, 59300, France

  • Clinique du Bois - Centre Bourgogne

    Lille, 59000, France

  • Institut André Dutreix

    Dunkirk, 59240, France

More trials for these conditions

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