Ignite Creation Date:
2025-12-24 @ 5:18 PM
Ignite Modification Date:
2025-12-28 @ 5:04 AM
Study NCT ID:
NCT01104350
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-06-03
First Post:
2010-04-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Image-Guided Radiation Therapy for Bladder-Cancer Patients Undergoing Radiotherapy and Concurrent Gemcitabine Chemotherapy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001749', 'term': 'Urinary Bladder Neoplasms'}], 'ancestors': [{'id': 'D014571', 'term': 'Urologic Neoplasms'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D001745', 'term': 'Urinary Bladder Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000093542', 'term': 'Gemcitabine'}], 'ancestors': [{'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D003841', 'term': 'Deoxycytidine'}, {'id': 'D003562', 'term': 'Cytidine'}, {'id': 'D011741', 'term': 'Pyrimidine Nucleosides'}, {'id': 'D011743', 'term': 'Pyrimidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 19}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2010-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2026-04', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-06-02', 'studyFirstSubmitDate': '2010-04-14', 'studyFirstSubmitQcDate': '2010-04-14', 'lastUpdatePostDateStruct': {'date': '2025-06-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2010-04-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2026-04', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To determine the dose limiting toxicity and establish the maximal tolerated dose', 'timeFrame': '2 years'}], 'secondaryOutcomes': [{'measure': 'To determine the complete response rate of the primary tumor', 'timeFrame': '4-6 weeks following consolidation therapy'}, {'measure': 'To determine the long term toxicity', 'timeFrame': '2 years'}]}, 'conditionsModule': {'keywords': ['Bladder', 'Radiotherapy', 'Gemcitabine', 'Chemotherapy', '10-031'], 'conditions': ['Bladder Cancer']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.mskcc.org/mskcc/html/44.cfm', 'label': 'Memorial Sloan Kettering Cancer Center'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to test the safety of different amounts (doses) of external radiation therapy (high-energy x-rays that shrink or destroy cancer) combined with chemotherapy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* MSKCC-reviewed pathologically proven diagnosis of primary bladder urothelial carcinoma without evidence of regional (nodal) or distant spread (cT1-T4a, Nx or N0).\n* Karnofsky Performance Scale (KPS) ≥ 70%\n* Age ≥18 years old\n* Adequately functioning bladder, defined as continent and without the need for an indwelling catheter\n* Absolute neutrophil count (ANC) ≥ 1500/mL; platelets ≥ 100,000/mm3 serum bilirubin \\< 1.5 x the upper limit of normal (ULN); aspartate aminotransferase (AST) and/alanine aminotransferase (ALT) ≤ 1.5 × ULN\n* Adequate renal function: calculated creatinine clearance \\> 30 mL/min/1.73 m2 using the following formula modified Cockcroft and Gault Formula for estimated Creatinine Clearance\n* Patients must be considered able to tolerate systemic chemotherapy and pelvic radiation therapy.\n* Patients must have the ability to understand and the willingness to sign a written informed consent document\n\nExclusion Criteria:\n\n* Evidence of distant disease or histologically-proven nodal metastases. Patients with radiologic evidence of lymphadenopathy must have biopsy proof of N0 status.\n* Previous pelvic radiation therapy\n* Prior systemic chemotherapy non-cisplatin based neoadjuvant for urothelial carcinoma (prior intravesical chemotherapy or immunotherapy is permissible)\n* Prior cisplatin based neoadjuvant systemic chemotherapy for more than \\>4 cycles\n* Active inflammatory bowel disease (i.e., Crohn's disease or ulcerative colitis)\n* Women who are pregnant or lactating"}, 'identificationModule': {'nctId': 'NCT01104350', 'briefTitle': 'Image-Guided Radiation Therapy for Bladder-Cancer Patients Undergoing Radiotherapy and Concurrent Gemcitabine Chemotherapy', 'organization': {'class': 'OTHER', 'fullName': 'Memorial Sloan Kettering Cancer Center'}, 'officialTitle': 'Phase I Dose-Escalation Study of Image-Guided Radiation Therapy for Bladder-Cancer Patients Undergoing Radiotherapy and Concurrent Gemcitabine Chemotherapy', 'orgStudyIdInfo': {'id': '10-031'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Radiotherapy and Concurrent Gemcitabine Chemotherapy', 'description': 'This is a Phase I dose-escalation study examining the safety and tolerability of intensity modulated external radiation therapy using image-guidance in combination with gemcitabine chemotherapy as an alternative to radical cystectomy.', 'interventionNames': ['Other: external radiation therapy with gemcitabine']}], 'interventions': [{'name': 'external radiation therapy with gemcitabine', 'type': 'OTHER', 'description': 'All patients will undergo daily image-guided radiation therapy with concurrent twice weekly gemcitabine chemotherapy. Radiation therapy will begin 2-4 weeks after restaging cystoscopy/fiducial marker placement.\n\n* Dose level #1: 23.4 Gy/1.8 Gy × 13 fractions (total dose 68.4 Gy)\n* Dose level #2: 27.0 Gy/1.8 Gy × 15 fractions (total dose 72.0 Gy)\n* Dose level #3: 30.6 Gy/1.8 Gy × 17 fractions (total dose 75.6 Gy)', 'armGroupLabels': ['Radiotherapy and Concurrent Gemcitabine Chemotherapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '07920', 'city': 'Basking Ridge', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Memorial Sloan Kettering at Basking Ridge', 'geoPoint': {'lat': 40.70621, 'lon': -74.54932}}, {'zip': '11725', 'city': 'Commack', 'state': 'New York', 'country': 'United States', 'facility': 'Memorial Sloan Kettering Cancer Center @ Suffolk', 'geoPoint': {'lat': 40.84288, 'lon': -73.29289}}, {'zip': '10604', 'city': 'Harrison', 'state': 'New York', 'country': 'United States', 'facility': 'Memorial Sloan Kettering Westchester', 'geoPoint': {'lat': 40.96899, 'lon': -73.71263}}, {'zip': '10065', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Memorial Sloan Kettering Cancer Center', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'city': 'Rockville Centre', 'state': 'New York', 'country': 'United States', 'facility': 'Memorial Sloan Kettering at Mercy Medical Center', 'geoPoint': {'lat': 40.65871, 'lon': -73.64124}}], 'overallOfficials': [{'name': 'Marisa Kollmeier, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Memorial Sloan Kettering Cancer Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Memorial Sloan Kettering Cancer Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}