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Trial record 33 of 1544 for:    rectal cancer

Combination of Metformin to Neoadjuvant Radiochemotherapy in the Treatment of Locally Advanced Rectal Cancer (METCAP).

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02437656
Recruitment Status : Completed
First Posted : May 7, 2015
Last Update Posted : October 25, 2017
Information provided by (Responsible Party):
Centre Oscar Lambret

Brief 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. 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.

Condition or disease Intervention/treatment Phase
Rectal Cancer Drug: Metformin Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Study Evaluating the Efficacy of the Combination of Metformin to Neoadjuvant Radiochemotherapy in the Treatment of Locally Advanced Rectal Cancer.
Study Start Date : May 2015
Actual Primary Completion Date : March 2017
Actual Study Completion Date : March 2017

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Metformin treatment

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)

Drug: Metformin

J3 - J10 (7 days minimum) : 850 mg 2 times / day

J10 - 48h before surgery : 850 mg 3 times / day

Other Names:
  • Glucophage
  • Diabamyl
  • Stagid

Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. 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) ]
  2. Sphincter preservation rate and downstaging rate [ Time Frame: within 30 days after surgery ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02437656

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Centre Marie Curie
Arras, France, 62000
Centre Pierre Curie
Beuvry, France, 62880
Centre Léonard de Vinci - SARL du pont Saint Vaast
Douai, France, 59500
Institut André Dutreix
Dunkerque, France, 59240
Centre Hospitalier
Lens, France, 62300
Clinique du Bois - Centre Bourgogne
Lille, France, 59000
Centre Oscar Lambret
Lille, France, 59020
Centre Galilée - Hôpital Privé La Louvière
Lille, France, 59045
Centre Gray
Maubeuge, France, 59600
Centre Joliot-Curie
St Martin-Boulogne, France, 62200
Clinique des Dentellières
Valenciennes, France, 59300
Sponsors and Collaborators
Centre Oscar Lambret
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Principal Investigator: Xavier MIRABEL, MD Centre Oscar Lambret

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Responsible Party: Centre Oscar Lambret Identifier: NCT02437656     History of Changes
Other Study ID Numbers: METCAP-1404
2014-003687-20 ( EudraCT Number )
First Posted: May 7, 2015    Key Record Dates
Last Update Posted: October 25, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Centre Oscar Lambret:
Rectal cancer
Additional relevant MeSH terms:
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Rectal Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Rectal Diseases
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Hypoglycemic Agents
Physiological Effects of Drugs