Ignite Creation Date:
2025-12-25 @ 4:18 AM
Ignite Modification Date:
2025-12-26 @ 3:18 AM
Study NCT ID:
NCT06712420
Status:
RECRUITING
Last Update Posted:
2025-04-16
First Post:
2024-10-22
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Neoadjuvant Chemotherapy for Locally Advanced Gall Bladder Cancer : a Randomized Control Trial (NEOGB)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005706', 'term': 'Gallbladder Neoplasms'}], 'ancestors': [{'id': 'D001661', 'term': 'Biliary Tract Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D001660', 'term': 'Biliary Tract Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005705', 'term': 'Gallbladder Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D020360', 'term': 'Neoadjuvant Therapy'}], 'ancestors': [{'id': 'D003131', 'term': 'Combined Modality Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 114}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2028-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-04-13', 'studyFirstSubmitDate': '2024-10-22', 'studyFirstSubmitQcDate': '2024-11-26', 'lastUpdatePostDateStruct': {'date': '2025-04-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-12-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-04', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'improvement in 3 year overall survival', 'timeFrame': '3 year', 'description': 'To compare the 3 year overall survival with Neoadjuvant chemotherapy and surgery versus upfront surgery in locally advanced resectable gall bladder cancer'}], 'secondaryOutcomes': [{'measure': 'post operative outcomes', 'timeFrame': '90 days', 'description': 'To compare mortality and morbidity rate in two groups'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['gallbladder, locally advanced, neoadjuvant'], 'conditions': ['Gall Bladder Carcinoma']}, 'descriptionModule': {'briefSummary': 'to study role of chemotherapy treatment for gall bladder cancer before surgery as compared to surgery directly', 'detailedDescription': 'Gallbladder cancer is a highly aggressive disease with a late presentation and poor prognosis. Complete surgical excision remains the only potentially curative treatment for early-stage gallbladder cancer.\n\nThe use and benefit of chemotherapy in gallbladder cancer before surgery , that is , in the neoadjuvant setting, is not well studied and, to our knowledge, neoadjuvant chemotherapy has not been evaluated in any randomized clinical trial.\n\nNeoadjuvant chemotherapy aims to achieve tumor downstaging, increase the radical surgical resection rate, reduce metastases. This study will compare the effectiveness of chemotherapy before surgery in locally advanced gall bladder cancer versus upfront surgery with respect to survival and completeness of resection of disease.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* ECOG 0-2\n* Locally advanced resectable GBC defined as Clinical T3/4 disease or Regional LN involvement on imaging studies.\n* Post cholecystectomy GBC with residual disease on imaging, History of bile spillage during primary surgery , history of piece-meal removal of gall bladder during simple cholecystectomy, Regional LN involvement on imaging studies.\n\nExclusion Criteria:\n\n1. Early GBC ( cT1/T2) without significant lymphadenopathy or liver infiltration on radiological imaging .\n2. Locally advanced disease requiring major hepatectomy or whipple's pancreatoduodenectomy.\n3. Post cholecystectomy GBC without any evidence of spillage of residual disease on radiological imaging.\n4. Obstructive jaundice due to involvement of biliary tree by tumour.\n5. Vascular involvement such as common hepatic artery, MPV right hepatic artery or right portal vein.\n6. Any distant metastasis or isolated port site metastasis\n7. Involvement of non-regional LN (e.g . Celiac LN, SMA lymph node, inter-aortocaval or left para-ortic LN).\n8. Poor performance status ECOG 3 or more.\n9. Pregnancy.\n10. Inability or unwillingness to follow study protocol"}, 'identificationModule': {'nctId': 'NCT06712420', 'acronym': 'NEOGB', 'briefTitle': 'Neoadjuvant Chemotherapy for Locally Advanced Gall Bladder Cancer : a Randomized Control Trial (NEOGB)', 'organization': {'class': 'OTHER', 'fullName': 'Rajiv Gandhi Cancer Institute & Research Center, India'}, 'officialTitle': 'Neoadjuvant Chemotherapy Versus Upfront Surgery for Locally Advanced Resectable Gall Bladder Cancer : A Randomized Trial', 'orgStudyIdInfo': {'id': 'RGCIRC/IRB-BHR/26/2024'}, 'secondaryIdInfos': [{'id': 'RES/SCM/61/2023/89', 'type': 'OTHER', 'domain': 'RAJIV GANDHI CANCER INSTITUTE AND REASEARCH CENTRE,INDIA'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'upfront surgery', 'description': 'after staging workup and biopsy, patient being taken up for upfront surgical exploration will undergo staging laparoscopy followed by exploration and interaortocaval lymphnode sampling. After ruling out distant metastasis, local resectability will be reassessed and curative surgery will be performed. . Post-operative complications were recorded and graded according Clavien Dindo classification', 'interventionNames': ['Procedure: curative surgery']}, {'type': 'EXPERIMENTAL', 'label': 'Neoadjuvant chemotherapy followed by surgery', 'description': 'NACT group will receive gemcitabine and platinum combination. Most common regimen comprised of gemcitabine (1000 mg/ m2 intravenously over 30-60 min) on days 1 and 8, and cisplatin (75 mg/ m2 intravenously over 2 h) on day 1, every 21 days. In case of renal compromise, carboplatin was used. Response was assessed using CECT abdomen and PET scan. Chemotherapy related toxicity will be graded according to Common Terminology Criteria for Adverse Events (CTCAE) v 5 .0.', 'interventionNames': ['Drug: neoadjuvant chemotherapy', 'Procedure: curative surgery']}], 'interventions': [{'name': 'neoadjuvant chemotherapy', 'type': 'DRUG', 'otherNames': ['NACT'], 'description': 'NACT group will receive gemcitabine and platinum combination. Most common regimen comprised of gemcitabine (1000 mg/ m2 intravenously over 30-60 min) on days 1 and 8, and cisplatin (75 mg/ m2 intravenously over 2 h) on day 1, every 21 days. In case of renal compromise, carboplatin was used. Response was assessed using CECT abdomen and PET scan. Chemotherapy related toxicity will be graded according to Common Terminology Criteria for Adverse Events (CTCAE) v 5 .0. PAtients will undergo curative surgery after neoadjuvant chemotherapy', 'armGroupLabels': ['Neoadjuvant chemotherapy followed by surgery']}, {'name': 'curative surgery', 'type': 'PROCEDURE', 'description': 'Patient being taken up for surgical exploration will undergo staging laparoscopy followed by exploration and interaortocaval lymphnode sampling. After ruling out distant metastasis, local resectability will be reassessed and curative surgery will be performed. . Post-operative complications were recorded and graded according Clavien Dindo classification', 'armGroupLabels': ['Neoadjuvant chemotherapy followed by surgery', 'upfront surgery']}]}, 'contactsLocationsModule': {'locations': [{'zip': '110085', 'city': 'Delhi', 'state': 'National Capital Territory of Delhi', 'status': 'RECRUITING', 'country': 'India', 'contacts': [{'name': 'Shivendra Singh, Mch', 'role': 'CONTACT', 'email': 'shiven_24@yahoo.co.in', 'phone': '+919818975024'}, {'name': 'Shaifali Goel, DrNB', 'role': 'CONTACT', 'email': 'doctor.shaifali@gmail.com', 'phone': '+918368382060'}], 'facility': 'Rajiv Gandhi Cancer Institute and Research Centre', 'geoPoint': {'lat': 28.65195, 'lon': 77.23149}}, {'zip': '110085', 'city': 'Delhi', 'state': 'National Capital Territory of Delhi', 'status': 'RECRUITING', 'country': 'India', 'contacts': [{'name': 'Shivendra Singh, Mch Surgical Gastroenterology', 'role': 'CONTACT', 'email': 'shiven_24@yahoo.com', 'phone': '+919818975024'}, {'name': 'Shaifali Goel, DrNB Surgical Gastroenterology', 'role': 'CONTACT', 'email': 'doctor.shaifali@gmail.com', 'phone': '+918368382060'}, {'name': 'Shivendra Singh, Mch Surgical Gastroenterology', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Rajiv Gandhi Cancer Institute and Research Centre', 'geoPoint': {'lat': 28.65195, 'lon': 77.23149}}, {'zip': '110085', 'city': 'Delhi', 'state': 'National Capital Territory of Delhi', 'status': 'RECRUITING', 'country': 'India', 'facility': 'Rajiv Gandhi Cancer Institute and Research Centre', 'geoPoint': {'lat': 28.65195, 'lon': 77.23149}}], 'centralContacts': [{'name': 'Shivendra Singh, Mch', 'role': 'CONTACT', 'email': 'shiven_24@yahoo.co.in', 'phone': '+919818975024'}, {'name': 'Shaifali Goel, DrNB', 'role': 'CONTACT', 'email': 'doctor.shaifali@gmail.com', 'phone': '+918368382060'}], 'overallOfficials': [{'name': 'Shivendra Singh, Mch Surgical gastroenterology', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Rajiv Gandhi Cancer Institute and Research Centre'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Institutional Policy'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Rajiv Gandhi Cancer Institute & Research Center, India', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'DOCTOR', 'investigatorFullName': 'Shaifali Goel', 'investigatorAffiliation': 'Rajiv Gandhi Cancer Institute & Research Center, India'}}}}