Rectal CancerPhase 2METCAPNCT02437656
Combination of Metformin to Neoadjuvant Radiochemotherapy in the Treatment of Locally Advanced Rectal Cancer.
A Phase 2 study testing Metformin in people with Rectal Cancer, run by Centre Oscar Lambret at 11 sites in France.
Trial summary
Metformin is an oral antidiabetic of the biguanide class derived from galega officinalis. Historical cohort of patients with diabetes have shown that diabetics on Metformin had a better chance of survival than diabetics not on Metformin. These observations have led to in vitro studies of metformin on cancer cells. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rectal Cancer
- What is being tested?
- Metformin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 11 sitesFrance
- Study dates
- May 2015to Mar 2017
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient with an adenocarcinoma of the low or middle rectum.
- T3 or T4 stage (T evaluated by MRI and / or echo-endoscopy).
- Absence of distant metastasis.
- Patient requiring a radiochemotherapy.
- Correct hematological conditions : Neutrophils ≥ 1500 G / L, platelets ≥ 100 000 G / L.
- Age ≥ 18 years
Show all 9Show fewer
- Performance status (WHO) ≤ 2
- Lactatemia ≤ Higher standard of the sampling laboratory.
- For women of childbearing age, a contraceptive method is mandatory for the entire duration of the study.
Who cannot join
- Other histologies such as squamous cell carcinoma, neuroendocrine tumors, melanomas, etc.
- History of lactic acidosis.
- Any diabetes (According to the WHO definition : fasting plasma glucose (FPG) > 1.26 g / L-1).
- Ongoing antidiabetic treatment such as
- Biguanides, hypoglycemic sulfamides, glinides, GLP-1 analogue, gliptins, alpha-glucosidase inhibitors
- Insulin or insulin analogues
Show all 19Show fewer
- Hypersensitivity to capecitabine or to any of the excipients or to fluorouracil.
- History of severe and unexpected reactions to a fluoropyrimidine therapy.
- Patient with known deficiency to the dihydropyrimidine dehydrogenase (DPD).
- Hypersensitivity to metformin or to any of the excipients.
- Renal failure or impaired renal function (creatinine clearance < 60 ml / min).
- Severe infection.
- Acute or chronic disease which may cause tissue hypoxia such as heart or respiratory failure or recent myocardial infarction (< 6 months).
- Hepatic insufficiency, acute alcohol intoxication, alcoholism.
- Psychiatric inability to give consent.
- Contraindication to radiation therapy and/or chemotherapy.
- Treatment with sorivudine or its chemically related analogues, such as brivudine.
- Patient under tutorship or guardianship.
- Pregnant or breastfeeding women.
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
France11 sites
Centre Marie Curie
Arras, 62000
Centre Pierre Curie
Beuvry, 62880
Centre Léonard de Vinci - SARL du pont Saint Vaast
Douai, 59500
Institut André Dutreix
Dunkirk, 59240
Centre Hospitalier
Lens, 62300
Clinique du Bois - Centre Bourgogne
Lille, 59000
Centre Oscar Lambret
Lille, 59020
Centre Galilée - Hôpital Privé La Louvière
Lille, 59045
Centre Gray
Maubeuge, 59600
Centre Joliot-Curie
Saint-Martin-Boulogne, 62200
Clinique des Dentellières
Valenciennes, 59300
About this study
Official title: Phase II Study Evaluating the Efficacy of the Combination of Metformin to Neoadjuvant Radiochemotherapy in the Treatment of Locally Advanced Rectal Cancer.
Metformin is an oral antidiabetic of the biguanide class derived from galega officinalis. Historical cohort of patients with diabetes have shown that diabetics on Metformin had a better chance of survival than diabetics not on Metformin. These observations have led to in vitro studies of metformin on cancer cells. It was thus demonstrated that Metformin has anti-proliferative properties.
The aim of our study is to evaluate the efficacy of metformin in combination with neoadjuvant radiochemotherapy in the treatment of locally advanced rectal cancer.
Read the detailed description
Patients eligible for the trial and having signed their consent to participate will undergo a dosimetric scan at baseline. 48 hours later (minimum), a Metformin therapy will be started at a dosage of 850 mg 2 times / day ( = 1700 mg / day). Seven days later (minimum) and up to 48 hours before surgery, the dosage of Metformin will be increased to 850 mg 3 times / day ( = 2550 mg / day). This very same day (J10), patients will start a radiochemotherapy. For 5 weeks, 5 days out of 7, patients will receive 800 mg/m² of Capecitabine 2 times / day (on morning and evening) ( = 1600 mg / m² / day) and a 3D irradiation or an Intensity-Modulated Radiation Therapy (IMRT) of a total dose of 50 Gy (5 sessions of 2 Gy per week). 6 to 8 weeks after completion of the chemoradiotherapy, surgery will be scheduled. It will consist of a tumor resection with total resection of the meso rectum.
Prior to the start of treatment, patients will have a clinical and a paraclinical examination and will undergo a laboratory examination. Once a week during the radiochemotherapy, patients will have a clinical examination and will undergo a laboratory examination. Three weeks after the end of the radiochemotherapy, patients will have a clinical examination. Before surgery, patients will have a clinical and a paraclinical examination. Finally, at the end of the study, patients will have a clinical examination.
- Conditions
- Rectal Cancer
- Being tested
- Metformin
- Keywords
- Radiochemotherapy, Metformin, Rectal cancer
- Medical subject headings
- Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MetforminDrug
Also called Glucophage, Diabamyl, Stagid
J3 - J10 (7 days minimum) : 850 mg 2 times / day
J10 - 48h before surgery : 850 mg 3 times / day
| Study group | Role | What they receive |
|---|---|---|
| Metformin treatment | Experimental | J1 : dosimetric scan
J3 : initiation of the Metformin therapy (at a dosage of 1700 mg / day)
J10 : increasing the dose of Metformin (2550 mg / day) + initiation of the radiochemotherapy
J44 : end of the radiochemotherapy
Between J86 and J100 : surgery (discontinuation of the Metformin therapy 48 hours before surgery) Receives: Drug: Metformin |
What is being measured
The primary outcome is the main question the study is designed to answer.
The efficacy will be assessed on the operative specimen by the complete histological response rate (absence of tumor cells : pCR).
Measured: within 30 days after surgery
Secondary outcomes (2)
Toxicity will be assessed according to NCI-CTCAE v4.0. Grades ≥ 3 related to metformin will be collected by the clinician.
Measured: up to 30 days after the end of the treatments (metformin and radiochemotherapy)
Sphincter preservation rate and downstaging rate
Measured: within 30 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2015 (estimated)
- Study startMay 2015
- Primary completionMar 2017
- Study completionMar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rectal CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Oscar Lambret
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Xavier MIRABEL, MD, Principal investigator, Centre Oscar Lambret
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02437656
- Sponsor's protocol ID
- METCAP-1404
- Other IDs
- 2014-003687-20, 2014
- Acronym
- METCAP
- Status last verified
- Mar 2026
- First submitted
- 5 May 2015
- Last updated
- 31 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study Evaluating the Efficacy of the Combination of Metformin to Neoadjuvant Radiochemotherapy in the Treatment of Locally Advanced Rectal Cancer.
- ClinicalTrials.gov ID
- NCT02437656
- Acronym / sponsor ID
- METCAP / METCAP-1404
- Conditions
- Rectal Cancer
- Keywords
- Radiochemotherapy, Metformin, Rectal cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Centre Oscar LambretUniversity, hospital or other
- Study start
- May 2015 (actual)
- Primary completion
- Mar 2017 (actual)
- Study completion
- Mar 2017 (actual)
- First posted
- 7 May 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Metformin is an oral antidiabetic of the biguanide class derived from galega officinalis. Historical cohort of patients with diabetes have shown that diabetics on Metformin had a better chance of survival than diabetics not on Metformin. These observations have led to in vitro studies of metformin on cancer cells. It was thus demonstrated that Metformin has anti-proliferative properties.
The aim of our study is to evaluate the efficacy of metformin in combination with neoadjuvant radiochemotherapy in the treatment of locally advanced rectal cancer.
Detailed description
Patients eligible for the trial and having signed their consent to participate will undergo a dosimetric scan at baseline. 48 hours later (minimum), a Metformin therapy will be started at a dosage of 850 mg 2 times / day ( = 1700 mg / day). Seven days later (minimum) and up to 48 hours before surgery, the dosage of Metformin will be increased to 850 mg 3 times / day ( = 2550 mg / day). This very same day (J10), patients will start a radiochemotherapy. For 5 weeks, 5 days out of 7, patients will receive 800 mg/m² of Capecitabine 2 times / day (on morning and evening) ( = 1600 mg / m² / day) and a 3D irradiation or an Intensity-Modulated Radiation Therapy (IMRT) of a total dose of 50 Gy (5 sessions of 2 Gy per week). 6 to 8 weeks after completion of the chemoradiotherapy, surgery will be scheduled. It will consist of a tumor resection with total resection of the meso rectum.
Prior to the start of treatment, patients will have a clinical and a paraclinical examination and will undergo a laboratory examination. Once a week during the radiochemotherapy, patients will have a clinical examination and will undergo a laboratory examination. Three weeks after the end of the radiochemotherapy, patients will have a clinical examination. Before surgery, patients will have a clinical and a paraclinical examination. Finally, at the end of the study, patients will have a clinical examination.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Metformin treatment | Experimental | Drug: MetforminJ1 : dosimetric scan J3 : initiation of the Metformin therapy (at a dosage of 1700 mg / day) J10 : increasing the dose of Metformin (2550 mg / day) + initiation of the radiochemotherapy J44 : end of the radiochemotherapy Between J86 and J100 : surgery (discontinuation of the Metformin therapy 48 hours before surgery) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Patient with an adenocarcinoma of the low or middle rectum.
- T3 or T4 stage (T evaluated by MRI and / or echo-endoscopy).
- Absence of distant metastasis.
- Patient requiring a radiochemotherapy.
- Correct hematological conditions : Neutrophils ≥ 1500 G / L, platelets ≥ 100 000 G / L.
Key exclusion criteria (19 listed)
- Other histologies such as squamous cell carcinoma, neuroendocrine tumors, melanomas, etc.
- History of lactic acidosis.
- Any diabetes (According to the WHO definition : fasting plasma glucose (FPG) > 1.26 g / L-1).
- Ongoing antidiabetic treatment such as
- Hypersensitivity to capecitabine or to any of the excipients or to fluorouracil.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MetforminAlso: Glucophage, Diabamyl, StagidJ3 - J10 (7 days minimum) : 850 mg 2 times / day J10 - 48h before surgery : 850 mg 3 times / day | Drug | Metformin treatment |
Primary outcome
The efficacy will be assessed on the operative specimen by the complete histological response rate (absence of tumor cells : pCR).
Time frame: within 30 days after surgery
2 secondary outcomes
Toxicity will be assessed according to NCI-CTCAE v4.0. Grades ≥ 3 related to metformin will be collected by the clinician.
Time frame: up to 30 days after the end of the treatments (metformin and radiochemotherapy)
Sphincter preservation rate and downstaging rate
Time frame: within 30 days after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Xavier MIRABEL, MD principal investigator
Centre Oscar Lambret
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Metformin in people with Rectal Cancer, run by Centre Oscar Lambret at 11 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The efficacy will be assessed on the operative specimen by the complete histological response rate (absence of tumor cells : pCR). (time frame: within 30 days after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Mar 2026.