Ignite Creation Date:
2025-12-24 @ 11:30 PM
Ignite Modification Date:
2025-12-25 @ 9:18 PM
Study NCT ID:
NCT05493956
Status:
UNKNOWN
Last Update Posted:
2022-09-09
First Post:
2022-08-03
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Randomised Study of Consolidation CTRT Versus Observation After First Line Chemotherapy in Advanced Gallbladder Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D059248', 'term': 'Chemoradiotherapy'}, {'id': 'D019370', 'term': 'Observation'}], 'ancestors': [{'id': 'D003131', 'term': 'Combined Modality Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D004358', 'term': 'Drug Therapy'}, {'id': 'D011878', 'term': 'Radiotherapy'}, {'id': 'D008722', 'term': 'Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Consolidation chemoradiation'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 120}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2019-04-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-08', 'completionDateStruct': {'date': '2023-02', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-09-07', 'studyFirstSubmitDate': '2022-08-03', 'studyFirstSubmitQcDate': '2022-08-06', 'lastUpdatePostDateStruct': {'date': '2022-09-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-08-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Overall survival', 'timeFrame': 'one year', 'description': 'Time from diagnosis to death'}], 'secondaryOutcomes': [{'measure': 'Progression free survival', 'timeFrame': 'one year', 'description': 'time from diagnosis to evidence of disease progression'}, {'measure': 'Toxicity due to consolidation chemoradiation', 'timeFrame': '24 weeks', 'description': 'Toxicity during and after completion of chemo-radiotherapy'}, {'measure': 'Hepatobiliary symptom index', 'timeFrame': '24 weeks', 'description': 'Hepatobiliary symptom index ((physical, social, emotional and functional well being according to Fact-hep score)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Gallbladder Cancer Unresectable']}, 'descriptionModule': {'briefSummary': 'This will be a phase III randomized trial of advanced gall bladder cancers. 140 patients will be randomized. Randomisation will be on a 1:1 ratio between the experimental arm and the control arm.\n\nObservation Arm : 6 cycles of Chemotherapy with Gemcitabine and Cisplatin will be followed by observation Chemotherapy followed by Chemo-radiotherapy Arm (CTRT): 6 cycles of Chemotherapy with Gemcitabine and Cisplatin will be followed by Concurrent Chemo-radiation with capecitabine (experimental arm).', 'detailedDescription': 'Treatment:\n\nChemotherapy followed by Chemo-radiotherapy:\n\nPatients in experimental arm will be administered 6 cycles of gemcitabine 1000 mg/m2 d 1+8 and cisplatin 25mg/m2 d 1+8 repeated 3 weekly followed by abdominal radiotherapy using a standardized 3 dimensional conformal radiotherapy (3DCRT) technique on a linear accelerator operating at beam energy of \\>= 6MV.The total target dose of RT will be 45Gy in 25 fractions of 1.8 Gy to GBC and lymphatics (GBC, liver infiltration, periportal coeliac, superior mesenteric and paraortic lymphnodes till L2) followed by a boost of 9 Gy to the GBC. GBC mass alongwith liver infiltration would be GTV, and a 5mm margin around it would be GB\\_CTV. Nodal CTV would be delineated after combining PV, CA, SMA and aortic nodes. A Boolean of GB\\_CTV and Nodal CTV would be Final CTV. PTV margin would be 1 cm around Final CTV. DVH constraints would be : mean liver dose\\<30 Gy (liver would be delineated after subtracting GB\\_CTV), mean kidney dose \\<18 Gy (combining both kidneys). Other OAR to be delineated: stomach, bowel and their doses to be noted. Concurrent capecitabine to be given @1250 mg/m2 (Monday to Friday). Weekly clinical ,haemogram, LFT assessments will be done during the treatment.\n\nToxicities documented during adjuvant therapy will be recorded using the CTCAE version 3.0 (NCI 2006 scale). Toxicities arising more than 90 days since the completion of radiation therapy and attributed to radiation will be assessed according to CTCAE criteria and counted as late radiation toxicities.\n\nObservation : enrolled patients will be administered 6 cycles of gemcitabine 1000 mg/m2 d 1+8 and cisplatin 25mg/m2 d 1+8 repeated 3 weekly for 6 cycles and then kept on observation.\n\nQOL forms would be taken at baseline (before randomization, 2nd week RT and one week after completion of RT.)\n\nFollow-up:\n\nInterim analysis will be done at 50% recruitment or at 1.5 years of study whichever is earlier. After completion of treatment patients will be followed up and assessed clinically every month till disease progression. A CECT abdomen at 2 months would be done to assess response to treatment. Patients who develop symptoms of disease progression would be advised CECT scan to confirm disease progression before administering second-line chemotherapy (CAPIRI). Quality of Life assessment: This will be done using FACT hepatic scale at the time of randomization, second week of radiotherapy and one month after completion of radiotherapy.\n\nIn the control arm it will be assessed at the time of randomization, and at one month and 3 months of follow-up. Sample size estimation Assuming 2 year survival probability of the patients were 0.25 and 0.08 in the treatment (group1) and control (group2), at minimum two sided 95% confidence interval and 80% power of the study, overall sample size came out to be 132 subjects (66 in the group1 and 66 in the group2) using a two-sided log rank test. The proportion dropping out in each of the treatment and control group was 0.10 (ie10%). The proportion of switching from the treatment to control or control to treatment is assumed to be Nil.\n\nTherefore in this study 70-70 patients will be included in the treatment and control groups (total 140).\n\nSample size was estimated using power analysis and sample size version-8 (PASS-2008).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Rt hepatic artery involvement\n* Rt Branch of portal vein and main PV involvement\n* CBD/CHD/primary biliary confluence involvement\n* Duodenum, pancreas, colon involvement\n* omental metastases, liver involvement limited to segment 4,5\n* Nodes in the hepato-duodenal, peripancreatic, common hepatic artery region, Para or preaortic region\n* Good performance status\n* BMI \\>15\n* Have normal organ and marrow function\n\nExclusion Criteria:\n\n* Multiple liver Metastasis as evident on CT scan abdomen .\n* Presence of ascites\n* Presence of jaundice (obstructive jaundice)\n* Poor performance status (KPS\\<70)'}, 'identificationModule': {'nctId': 'NCT05493956', 'acronym': 'RACE-GB', 'briefTitle': 'A Randomised Study of Consolidation CTRT Versus Observation After First Line Chemotherapy in Advanced Gallbladder Cancer', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Sanjay Gandhi Postgraduate Institute of Medical Sciences'}, 'officialTitle': 'A Randomised Study of Consolidation CTRT Versus Observation After First Line Chemotherapy in Advanced Gallbladder Cancer: RACE-GB Study', 'orgStudyIdInfo': {'id': '2019-30-IP-108'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Consolidation chemoradiation', 'description': '6 cycles of Chemotherapy with Gemcitabine and Cisplatin will be followed by Concurrent Chemo-radiation with capecitabine', 'interventionNames': ['Radiation: chemoradiation']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Observation', 'description': '6 cycles of Chemotherapy with Gemcitabine and Cisplatin will be followed by observation', 'interventionNames': ['Radiation: chemoradiation']}], 'interventions': [{'name': 'chemoradiation', 'type': 'RADIATION', 'otherNames': ['Observation'], 'description': 'Radiation dose of 54 Gy will be given alongwith concurrent capecitabine', 'armGroupLabels': ['Consolidation chemoradiation', 'Observation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '226014', 'city': 'Lucknow', 'state': 'Uttar Pradesh', 'status': 'RECRUITING', 'country': 'India', 'contacts': [{'name': 'Sushma Agrawal, MD', 'role': 'CONTACT'}, {'name': 'Rahul Rahul', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Ashish Singh', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Prabhakar Mishra', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Rajan Saxena', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Sanjay Gandhi Postgraduate Institute of Medical Sciences', 'geoPoint': {'lat': 26.83928, 'lon': 80.92313}}], 'centralContacts': [{'name': 'Sushma Agrawal, MD', 'role': 'CONTACT', 'email': 'sushmaagrawal@yahoo.co.uk', 'phone': '91522249', 'phoneExt': '4454'}], 'overallOfficials': [{'name': 'Sushma Agrawal, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'SGPGIMS'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sanjay Gandhi Postgraduate Institute of Medical Sciences', 'class': 'OTHER_GOV'}, 'collaborators': [{'name': 'American Society of Clinical Oncology', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}