Ignite Creation Date:
2025-12-24 @ 11:31 PM
Ignite Modification Date:
2026-04-23 @ 5:02 PM
Study NCT ID:
NCT02437656
Status:
COMPLETED
Last Update Posted:
2017-10-25
First Post:
2015-05-05
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Combination of Metformin to Neoadjuvant Radiochemotherapy in the Treatment of Locally Advanced Rectal Cancer (METCAP).
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012004', 'term': 'Rectal Neoplasms'}], 'ancestors': [{'id': 'D015179', 'term': 'Colorectal Neoplasms'}, {'id': 'D007414', 'term': 'Intestinal Neoplasms'}, {'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D012002', 'term': 'Rectal Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D008687', 'term': 'Metformin'}], 'ancestors': [{'id': 'D001645', 'term': 'Biguanides'}, {'id': 'D006146', 'term': 'Guanidines'}, {'id': 'D000578', 'term': 'Amidines'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-10', 'completionDateStruct': {'date': '2017-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-10-24', 'studyFirstSubmitDate': '2015-05-05', 'studyFirstSubmitQcDate': '2015-05-06', 'lastUpdatePostDateStruct': {'date': '2017-10-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-05-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The efficacy will be assessed on the operative specimen by the complete histological response rate (absence of tumor cells : pCR).', 'timeFrame': 'within 30 days after surgery'}], 'secondaryOutcomes': [{'measure': 'Toxicity will be assessed according to NCI-CTCAE v4.0. Grades ≥ 3 related to metformin will be collected by the clinician.', 'timeFrame': 'up to 30 days after the end of the treatments (metformin and radiochemotherapy)'}, {'measure': 'Sphincter preservation rate and downstaging rate', 'timeFrame': 'within 30 days after surgery'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Radiochemotherapy', 'Metformin', 'Rectal cancer'], 'conditions': ['Rectal Cancer']}, 'descriptionModule': {'briefSummary': '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.\n\nThe aim of our study is to evaluate the efficacy of metformin in combination with neoadjuvant radiochemotherapy in the treatment of locally advanced rectal cancer.', 'detailedDescription': '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.\n\nPrior 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Patient with an adenocarcinoma of the low or middle rectum.\n2. T3 or T4 stage (T evaluated by MRI and / or echo-endoscopy).\n3. Absence of distant metastasis.\n4. Patient requiring a radiochemotherapy.\n5. Correct hematological conditions : Neutrophils ≥ 1500 G / L, platelets ≥ 100 000 G / L.\n6. Age ≥ 18 years\n7. Performance status (WHO) ≤ 2\n8. Lactatemia ≤ Higher standard of the sampling laboratory.\n9. For women of childbearing age, a contraceptive method is mandatory for the entire duration of the study.\n\nExclusion Criteria:\n\n1. Other histologies such as squamous cell carcinoma, neuroendocrine tumors, melanomas, etc.\n2. History of lactic acidosis.\n3. Any diabetes (According to the WHO definition : fasting plasma glucose (FPG) \\> 1.26 g / L-1).\n4. Ongoing antidiabetic treatment such as\n\n * Biguanides, hypoglycemic sulfamides, glinides, GLP-1 analogue, gliptins, alpha-glucosidase inhibitors\n * Insulin or insulin analogues\n5. Hypersensitivity to capecitabine or to any of the excipients or to fluorouracil.\n6. History of severe and unexpected reactions to a fluoropyrimidine therapy.\n7. Patient with known deficiency to the dihydropyrimidine dehydrogenase (DPD).\n8. Hypersensitivity to metformin or to any of the excipients.\n9. Renal failure or impaired renal function (creatinine clearance \\< 60 ml / min).\n10. Severe infection.\n11. Acute or chronic disease which may cause tissue hypoxia such as heart or respiratory failure or recent myocardial infarction (\\< 6 months).\n12. Hepatic insufficiency, acute alcohol intoxication, alcoholism.\n13. Psychiatric inability to give consent.\n14. Contraindication to radiation therapy and/or chemotherapy.\n15. Treatment with sorivudine or its chemically related analogues, such as brivudine.\n16. Patient under tutorship or guardianship.\n17. Pregnant or breastfeeding women.'}, 'identificationModule': {'nctId': 'NCT02437656', 'briefTitle': 'Combination of Metformin to Neoadjuvant Radiochemotherapy in the Treatment of Locally Advanced Rectal Cancer (METCAP).', 'organization': {'class': 'OTHER', 'fullName': 'Centre Oscar Lambret'}, 'officialTitle': 'Phase II Study Evaluating the Efficacy of the Combination of Metformin to Neoadjuvant Radiochemotherapy in the Treatment of Locally Advanced Rectal Cancer.', 'orgStudyIdInfo': {'id': 'METCAP-1404'}, 'secondaryIdInfos': [{'id': '2014-003687-20', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Metformin treatment', 'description': 'J1 : dosimetric scan\n\nJ3 : initiation of the Metformin therapy (at a dosage of 1700 mg / day)\n\nJ10 : increasing the dose of Metformin (2550 mg / day) + initiation of the radiochemotherapy\n\nJ44 : end of the radiochemotherapy\n\nBetween J86 and J100 : surgery (discontinuation of the Metformin therapy 48 hours before surgery)', 'interventionNames': ['Drug: Metformin']}], 'interventions': [{'name': 'Metformin', 'type': 'DRUG', 'otherNames': ['Glucophage', 'Diabamyl', 'Stagid'], 'description': 'J3 - J10 (7 days minimum) : 850 mg 2 times / day\n\nJ10 - 48h before surgery : 850 mg 3 times / day', 'armGroupLabels': ['Metformin treatment']}]}, 'contactsLocationsModule': {'locations': [{'zip': '62000', 'city': 'Arras', 'country': 'France', 'facility': 'Centre Marie Curie', 'geoPoint': {'lat': 50.29301, 'lon': 2.78186}}, {'zip': '62880', 'city': 'Beuvry', 'country': 'France', 'facility': 'Centre Pierre Curie', 'geoPoint': {'lat': 50.51674, 'lon': 2.68541}}, {'zip': '59500', 'city': 'Douai', 'country': 'France', 'facility': 'Centre Léonard de Vinci - SARL du pont Saint Vaast', 'geoPoint': {'lat': 50.37069, 'lon': 3.07922}}, {'zip': '59240', 'city': 'Dunkirk', 'country': 'France', 'facility': 'Institut André Dutreix', 'geoPoint': {'lat': 51.0344, 'lon': 2.37681}}, {'zip': '62300', 'city': 'Lens', 'country': 'France', 'facility': 'Centre Hospitalier', 'geoPoint': {'lat': 50.43302, 'lon': 2.82791}}, {'zip': '59000', 'city': 'Lille', 'country': 'France', 'facility': 'Clinique du Bois - Centre Bourgogne', 'geoPoint': {'lat': 50.63391, 'lon': 3.05512}}, {'zip': '59020', 'city': 'Lille', 'country': 'France', 'facility': 'Centre Oscar Lambret', 'geoPoint': {'lat': 50.63391, 'lon': 3.05512}}, {'zip': '59045', 'city': 'Lille', 'country': 'France', 'facility': 'Centre Galilée - Hôpital Privé La Louvière', 'geoPoint': {'lat': 50.63391, 'lon': 3.05512}}, {'zip': '59600', 'city': 'Maubeuge', 'country': 'France', 'facility': 'Centre Gray', 'geoPoint': {'lat': 50.27875, 'lon': 3.97267}}, {'zip': '62200', 'city': 'Saint-Martin-Boulogne', 'country': 'France', 'facility': 'Centre Joliot-Curie', 'geoPoint': {'lat': 50.72691, 'lon': 1.61864}}, {'zip': '59300', 'city': 'Valenciennes', 'country': 'France', 'facility': 'Clinique des Dentellières', 'geoPoint': {'lat': 50.35909, 'lon': 3.52506}}], 'overallOfficials': [{'name': 'Xavier MIRABEL, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Centre Oscar Lambret'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Oscar Lambret', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}