Ignite Creation Date:
2025-12-25 @ 3:02 AM
Ignite Modification Date:
2026-01-28 @ 7:33 PM
Study NCT ID:
NCT01882933
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-05-08
First Post:
2013-06-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
D2 Resection and HIPEC (Hyperthermic Intraperitoneal Chemoperfusion) in Locally Advanced Gastric Carcinoma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000084262', 'term': 'Hyperthermic Intraperitoneal Chemotherapy'}], 'ancestors': [{'id': 'D017024', 'term': 'Chemotherapy, Adjuvant'}, {'id': 'D003131', 'term': 'Combined Modality Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D004358', 'term': 'Drug Therapy'}, {'id': 'D006979', 'term': 'Hyperthermia, Induced'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 367}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2013-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-05', 'completionDateStruct': {'date': '2026-05', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-05-07', 'studyFirstSubmitDate': '2013-06-13', 'studyFirstSubmitQcDate': '2013-06-20', 'lastUpdatePostDateStruct': {'date': '2024-05-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2013-06-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2026-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Overall survival', 'timeFrame': '5 years', 'description': 'From the date of surgery to the date of death or to the end of follow-up'}], 'secondaryOutcomes': [{'measure': 'Recurrence-free survival', 'timeFrame': '5 years', 'description': 'From the date of surgery to the date of recurrence or to the end of follow-up'}, {'measure': 'Recurrence-free survival', 'timeFrame': '3 years', 'description': 'From the date of surgery to the date of recurrence or to the end of follow-up'}, {'measure': 'Locoregional-free survival', 'timeFrame': '5 years', 'description': 'From the date of surgery to the date of locoregional recurrence or to the end of follow-up'}, {'measure': 'Treatment-related morbidity', 'timeFrame': 'During the 60th postoperative days', 'description': 'Common Terminology Criteria for Adverse Events v4.0'}, {'measure': 'Treatment-related mortality', 'timeFrame': 'During the 60th postoperative days'}, {'measure': 'Score QLQ-C30', 'timeFrame': '3 months (M3), 6 months (M6) and 12 months (M12) after surgery +/- HIPEC procedure.', 'description': 'Quality of life is assessed with EORTC questionnaire QLQ-C30'}, {'measure': 'Score QLQ-STO 22', 'timeFrame': '3 months (M3), 6 months (M6) and 12 months (M12) after surgery +/- HIPEC procedure.', 'description': 'Quality of life is assessed with EORTC questionnaire QLQ-STO 22'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Gastric adenocarcinoma', 'HIPEC', 'Oxaliplatin', 'Signet ring cell'], 'conditions': ['Gastric Adenocarcinoma']}, 'referencesModule': {'references': [{'pmid': '24628950', 'type': 'DERIVED', 'citation': 'Glehen O, Passot G, Villeneuve L, Vaudoyer D, Bin-Dorel S, Boschetti G, Piaton E, Garofalo A. GASTRICHIP: D2 resection and hyperthermic intraperitoneal chemotherapy in locally advanced gastric carcinoma: a randomized and multicenter phase III study. BMC Cancer. 2014 Mar 14;14:183. doi: 10.1186/1471-2407-14-183.'}]}, 'descriptionModule': {'briefSummary': 'A prospective, opened, multicentric, randomised, phase III trial with two arms:\n\n* Arm A: curative gastrectomy with D1-D2 lymph node dissection + HIPEC with oxaliplatin\n* Arm B: curative gastrectomy with D1-D2 lymph node dissection\n\nMain objective: Compare overall 5-year survival rates in patients surgically treated for advanced gastric adenocarcinoma (T3, T4 and/or N+ and/or with positive peritoneal cytology), treated either with curative gastrectomy and adjuvant HIPEC, or with curative gastrectomy alone.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18 \\< age ≤ 75 years old\n* White blood cells \\> 3,500/mm3, neutrophils ≥ 1,500/mm3, platelets ≥ 100,000/mm3\n* Good renal functions, serum creatinine values being \\< 1.5 mg/dl and creatinine clearance \\> 60 ml/min\n* Performance Status ≤1, Karnofsky Index ≥ 70%\n* Serum bilirubin ≤ 2 mg/dl\n* Having given written informed consent prior to any procedure related to the study.\n* Covered by a Health System where applicable, and/or in compliance with the recommendations of the national laws in force relating to biomedical research\n* Not under any administrative or legal supervision\n* Histologically evidenced resectable T3 or T4 gastric adenocarcinoma for which a curative gastrectomy is scheduled, with invasion into the serosa AND/OR lymph node metastasis (determined from data obtained by endoscopic ultrasound and chest, abdomen and pelvis CT scan) AND/OR positive peritoneal cytology (sampled during the preoperative laparoscopy).\n\nAND/OR\n\n* Perforated gastric adenocarcinoma AND/OR\n* Siewert III adenocarcinoma of the cardia for which a gastrectomy by exclusive abdominal laparotomy is scheduled\n* Females of childbearing age potential and male subjects with partners of childbearing potential using efficient contraceptive measures (as judged by the investigator).Subjects randomised in the arm with HIPEC should be informed and accept that these requirements should also extend to :\n\n * 4 months after the treatment with Oxaliplatin for female subjects,\n * 6 months after the treatment with Oxaliplatin for male subjects.\n\nExclusion Criteria:\n\n* Prior malignant tumors with detectable signs of recurrence\n* Gastric stump adenocarcinoma\n* Presence of comorbidities, notably serious chronic diseases or organ failure General conditions\n* Any subject in exclusion period of a previous study according to applicable regulations\n* Pregnancy or breastfeeding\n* Females of childbearing age potential or male subjects with partners of childbearing potential not using medically accepted contraceptive measures, as judged by the investigator Interfering substance\n* Contraindication to any drug contained in the chemotherapy regimen Specific to the study\n* Life threatening toxicity before surgery\n* Distant metastases (liver, lung. ovaries, etc)\n* Tumoral infiltration of the head or body of the pancreas\n* Patients presenting an adenocarcinoma of the cardia Siewert I or II\n* Existence of macroscopic peritoneal implants\n* Patients with clinically significant ascites (\\> 500 cc) even if cytology is negative for cancer cells, in the absence of other non-malignant causes of ascites'}, 'identificationModule': {'nctId': 'NCT01882933', 'acronym': 'GASTRICHIP', 'briefTitle': 'D2 Resection and HIPEC (Hyperthermic Intraperitoneal Chemoperfusion) in Locally Advanced Gastric Carcinoma', 'organization': {'class': 'OTHER', 'fullName': 'Hospices Civils de Lyon'}, 'officialTitle': 'GASTRICHIP : D2 Resection and HIPEC (Hyperthermic Intraperitoneal Chemoperfusion) in Locally Advanced Gastric Carcinoma. A Randomized and Multicentric Phase III Study.', 'orgStudyIdInfo': {'id': '2012.761'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Curative Gastrectomy + HIPEC', 'description': 'Curative gastrectomy with D1-D2 lymph node dissection + HIPEC with oxaliplatin', 'interventionNames': ['Drug: HIPEC (Hyperthermic Intraperitoneal Chemoperfusion) with oxaliplatin', 'Procedure: Curative gastrectomy']}, {'type': 'OTHER', 'label': 'Curative Gastrectomy', 'description': 'Curative gastrectomy with D1-D2 lymph node dissection', 'interventionNames': ['Procedure: Curative gastrectomy']}], 'interventions': [{'name': 'HIPEC (Hyperthermic Intraperitoneal Chemoperfusion) with oxaliplatin', 'type': 'DRUG', 'description': 'After the D2 resection is complete HIPEC can start. A roller pump forces the chemotherapy solution (oxaliplatin 250 mg/m² with 2 Liters of G5%/m²) into the abdomen through the inflow catheter and pulls it out through the drains. A heat exchanger keeps the intraperitoneal fluid at 42°-43°C.', 'armGroupLabels': ['Curative Gastrectomy + HIPEC']}, {'name': 'Curative gastrectomy', 'type': 'PROCEDURE', 'description': 'All the patients will undergo a D1-D2 gastrectomy carried out according to Japanese guidelines and to the European recommendations for the preservation of spleen and pancreas', 'armGroupLabels': ['Curative Gastrectomy', 'Curative Gastrectomy + HIPEC']}]}, 'contactsLocationsModule': {'locations': [{'zip': '80054', 'city': 'Amiens', 'country': 'France', 'facility': "Département de Chirurgie Digestive, CHU d'Amiens", 'geoPoint': {'lat': 49.9, 'lon': 2.3}}, {'zip': '49033', 'city': 'Angers', 'country': 'France', 'facility': 'Service de Chirurgie Digestive Oncologique, CLCC Paul Papin', 'geoPoint': {'lat': 47.47156, 'lon': -0.55202}}, {'zip': '49100', 'city': 'Angers', 'country': 'France', 'facility': "Département de Chirurgie Digestive - CHU d'Angers", 'geoPoint': {'lat': 47.47156, 'lon': -0.55202}}, {'zip': '25030', 'city': 'Besançon', 'country': 'France', 'facility': 'Service de Chirurgie Digestive, Hôpital Jean Minjoz, CHU Besançon', 'geoPoint': {'lat': 47.24878, 'lon': 6.01815}}, {'zip': '14076', 'city': 'Caen', 'country': 'France', 'facility': 'Service de Chirurgie Viscérale, CLCC François Baclesse', 'geoPoint': {'lat': 49.18585, 'lon': -0.35912}}, {'zip': '63003', 'city': 'Clermont-Ferrand', 'country': 'France', 'facility': 'Service de Chirurgie Viscérale, CHU Estaing', 'geoPoint': {'lat': 45.77969, 'lon': 3.08682}}, {'zip': '21079', 'city': 'Dijon', 'country': 'France', 'facility': 'Service de Chirurgie Digestive, Hôpital du Bocage', 'geoPoint': {'lat': 47.31344, 'lon': 5.01391}}, {'zip': '38043', 'city': 'Grenoble', 'country': 'France', 'facility': "Service de Chirurgie Digestive et de l'Urgence, Hôpital Michallon", 'geoPoint': {'lat': 45.17869, 'lon': 5.71479}}, {'zip': '59067', 'city': 'Lille', 'country': 'France', 'facility': 'Service de Chirurgie Digestive et Générale, Hôpital Huriez', 'geoPoint': {'lat': 50.63391, 'lon': 3.05512}}, {'zip': '69373', 'city': 'Lyon', 'country': 'France', 'facility': 'Service de Chirurgie Digestive, CLCC Léon Bérard', 'geoPoint': {'lat': 45.74906, 'lon': 4.84789}}, {'zip': '13005', 'city': 'Marseille', 'country': 'France', 'facility': "Service d'Oncologie Digestive, Hôpital de la Timone", 'geoPoint': {'lat': 43.29695, 'lon': 5.38107}}, {'zip': '34298', 'city': 'Montpellier', 'country': 'France', 'facility': "Service de Chirurgie Digestive, CRLC Val d'Aurelle", 'geoPoint': {'lat': 43.61093, 'lon': 3.87635}}, {'zip': '44805', 'city': 'Nantes', 'country': 'France', 'facility': 'Service de Chirurgie Digestive, CLCC René Gauducheau', 'geoPoint': {'lat': 47.21725, 'lon': -1.55336}}, {'zip': '06200', 'city': 'Nice', 'country': 'France', 'facility': 'Service de Chirurgie Digestive, Hôpital Archet II', 'geoPoint': {'lat': 43.70313, 'lon': 7.26608}}, {'zip': '75005', 'city': 'Paris', 'country': 'France', 'facility': 'Service de Chirurgie Digestive, Institut Curie', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '75010', 'city': 'Paris', 'country': 'France', 'facility': 'Service de Chirurgie Viscérale et Oncologique, Hôpital Saint-Louis', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '75012', 'city': 'Paris', 'country': 'France', 'facility': 'Service de Chirurgie Générale et Digestive, Hôpital Saint-Antoine, APHP', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '75475', 'city': 'Paris', 'country': 'France', 'facility': 'Service de Chirurgie Digestive, Hôpital Lariboisière', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '69495', 'city': 'Pierre-Bénite', 'country': 'France', 'facility': 'Service de Chirurgie Générale Digestive et Endocrinienne, Centre Hospitalier Lyon Sud, Hospices Civils de Lyon', 'geoPoint': {'lat': 45.70359, 'lon': 4.82424}}, {'zip': '86021', 'city': 'Poitiers', 'country': 'France', 'facility': 'Service de Chirurgie Viscérale, CHU de Poitiers', 'geoPoint': {'lat': 46.58261, 'lon': 0.34348}}, {'zip': '51092', 'city': 'Reims', 'country': 'France', 'facility': 'Service de Chirurgie Générale et Viscérale, CHU de Reims - Hôpital Robert Debré', 'geoPoint': {'lat': 49.26526, 'lon': 4.02853}}, {'zip': '76031', 'city': 'Rouen', 'country': 'France', 'facility': 'Service de Chirurgie Digestive et de Physiologie Digestive, Hôpital Ch. Nicolle', 'geoPoint': {'lat': 49.44313, 'lon': 1.09932}}, {'zip': '42055', 'city': 'Saint-Etienne', 'country': 'France', 'facility': 'Service de Chirurgie Digestive, Hôpital Nord', 'geoPoint': {'lat': 45.43389, 'lon': 4.39}}, {'zip': '67200', 'city': 'Strasbourg', 'country': 'France', 'facility': 'Service de Chirurgie Viscérale et Digestive, Hôpital de Hautepierre', 'geoPoint': {'lat': 48.58392, 'lon': 7.74553}}, {'zip': '31059', 'city': 'Toulouse', 'country': 'France', 'facility': 'Service de Chirurgie Générale et Digestive, Hôpital Purpan', 'geoPoint': {'lat': 43.60426, 'lon': 1.44367}}, {'zip': '54511', 'city': 'Vandœuvre-lès-Nancy', 'country': 'France', 'facility': 'Service de Chirurgie Digestive Oncologique, CLCC Alexis Vautrin', 'geoPoint': {'lat': 48.66115, 'lon': 6.17114}}, {'zip': '94805', 'city': 'Villejuif', 'country': 'France', 'facility': 'Département de Chirurgie Digestive et Hépatobiliaire, Institut Gustave Roussy', 'geoPoint': {'lat': 48.7939, 'lon': 2.35992}}, {'zip': '28805', 'city': 'Alcalá de Henares', 'country': 'Spain', 'facility': 'Hospital Universitario Principe de Asturias', 'geoPoint': {'lat': 40.48205, 'lon': -3.35996}}, {'zip': '08970', 'city': 'Barcelona', 'country': 'Spain', 'facility': 'Hospital Sant Joan Despí Moises Broggi', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'zip': '28033', 'city': 'Madrid', 'country': 'Spain', 'facility': 'Md Anderson Cancer Center', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'zip': '28040', 'city': 'Madrid', 'country': 'Spain', 'facility': 'Fundación Jiménez Díaz Hospital', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'zip': '28046', 'city': 'Madrid', 'country': 'Spain', 'facility': 'Hospital Universitario de La Paz', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'zip': '28942', 'city': 'Madrid', 'country': 'Spain', 'facility': 'Hospital Universitario de Fuenlabrada', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}], 'overallOfficials': [{'name': 'Olivier GLEHEN, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Service de Chirurgie Générale Digestive et Endocrinienne, Centre Hospitalier Lyon Sud, Hospices Civils de Lyon'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hospices Civils de Lyon', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}