Ignite Creation Date:
2025-12-24 @ 4:02 PM
Ignite Modification Date:
2025-12-27 @ 12:19 PM
Study NCT ID:
NCT04740866
Status:
UNKNOWN
Last Update Posted:
2021-02-09
First Post:
2021-02-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Adjuvant Radiotherapy Versus Observation After Radical Cystectomy in High Risk Urothelial Bladder Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D018714', 'term': 'Radiotherapy, Adjuvant'}], 'ancestors': [{'id': 'D003131', 'term': 'Combined Modality Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D011878', 'term': 'Radiotherapy'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2018-08-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-02', 'completionDateStruct': {'date': '2022-12-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-02-08', 'studyFirstSubmitDate': '2021-02-02', 'studyFirstSubmitQcDate': '2021-02-02', 'lastUpdatePostDateStruct': {'date': '2021-02-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-02-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Local Control', 'timeFrame': 'Two year', 'description': '2-year local-regional control rate'}], 'secondaryOutcomes': [{'measure': 'Disease Free Survival', 'timeFrame': 'Two year', 'description': '2-year disease free survival rate'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Adjuvant Radiotherapy', 'Neoadjuvant chemotherapy', 'Radical Cystectomy', 'high risk Urothelial Carcinoma Bladder', 'Local Control', 'Disease Free Survival (DFS)'], 'conditions': ['High-Risk Cancer', 'Urothelial Carcinoma Bladder']}, 'referencesModule': {'references': [{'pmid': '1612951', 'type': 'RESULT', 'citation': 'Zaghloul MS, Awwad HK, Akoush HH, Omar S, Soliman O, el Attar I. Postoperative radiotherapy of carcinoma in bilharzial bladder: improved disease free survival through improving local control. Int J Radiat Oncol Biol Phys. 1992;23(3):511-7. doi: 10.1016/0360-3016(92)90005-3.'}, {'pmid': '29188298', 'type': 'RESULT', 'citation': 'Zaghloul MS, Christodouleas JP, Smith A, Abdallah A, William H, Khaled HM, Hwang WT, Baumann BC. Adjuvant Sandwich Chemotherapy Plus Radiotherapy vs Adjuvant Chemotherapy Alone for Locally Advanced Bladder Cancer After Radical Cystectomy: A Randomized Phase 2 Trial. JAMA Surg. 2018 Jan 17;153(1):e174591. doi: 10.1001/jamasurg.2017.4591. Epub 2018 Jan 17.'}]}, 'descriptionModule': {'briefSummary': 'This is a prospective randomized clinical trial in high risk urothelial bladder cancer to compare adjuvant radiotherapy versus observation after radical cyctectomy. This is to clarify the benefit of adjuvant radiotherapy while limiting gastrointestinal toxicities for patients with pathological high-risk bladder cancer through assessing locoregional control (LRC).', 'detailedDescription': 'This is prospective randomized trial in high risk urothelial bladder cancer that includes 2 arms. The randomization will be done by permuted block method to 2 equal comparable groups. The total number of subjects will be 50 in each arm (Total=100 subjects).\n\nThis study include patients who may receive neoadjuvant chemotherapy \\[Gemcitabine+Cisplatin\\]) or not.\n\nArm (1) in this study (N=50) will received irradiation of both the bladder tumor bed and pelvic lymph nodes using IMRT technique. For Arm (2) (N=50) will undergo observation following radical cystectomy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nPatient with muscle-invasive urothelial cancer, who received neoadjuvant chemotherapy followed by radical cystectomy and urinary diversion with negative safety margin and belongs to one or more of the categories:\n\n* ≥ 18 years old.\n* PT3 or PT4a tumors.\n* Grade 3 urothelial cancer.\n* Positive infiltration of the dissected pelvic lymph nodes.\n\nExclusion Criteria:\n\n* Residual tumors upon cystectomy.\n* Previous pelvic irradiation.\n* Non-urothelial bladder tumors.\n* WHO performance status above 2.\n* Any psychological, familial, sociological or geographical condition that hamper compliance with the study and/ or follow up schedule.'}, 'identificationModule': {'nctId': 'NCT04740866', 'briefTitle': 'Adjuvant Radiotherapy Versus Observation After Radical Cystectomy in High Risk Urothelial Bladder Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Cairo University'}, 'officialTitle': 'Prospective Randomized Trial of Adjuvant Radiotherapy Versus Observation After Radical Cystectomy in High Risk Urothelial Bladder Cancer', 'orgStudyIdInfo': {'id': 'Bladder-03'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Adjuvant Radiotherapy', 'description': 'Irradiation of both the bladder tumor bed and pelvic lymph nodes using Intensity-Modulated Radiation-Therapy \\[IMRT\\] technique.', 'interventionNames': ['Radiation: Adjuvant Radiotherapy']}, {'type': 'NO_INTERVENTION', 'label': 'Observation after radical Cystectomy', 'description': 'observation following radical cystectomy'}], 'interventions': [{'name': 'Adjuvant Radiotherapy', 'type': 'RADIATION', 'description': 'Irradiation of both the bladder tumor bed and pelvic lymph nodes using Intensity-Modulated Radiation-Therapy (IMRT) technique. (\\[50Gy in 25 fractions conventional fractionation including tumor bed \\& pelvic lymph nodes\\]', 'armGroupLabels': ['Adjuvant Radiotherapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '11465', 'city': 'Cairo', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'Mohamed Zaghloul, MD', 'role': 'CONTACT', 'email': 'mszagh@yahoo.com', 'phone': '(20)01001720664'}, {'name': 'Mohamed Zaghloul, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'National Cancer Institute-Cairo University', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}], 'centralContacts': [{'name': 'Mohamed Zaghloul, MD', 'role': 'CONTACT', 'email': 'mszagh@yahoo.com', 'phone': '(20)-01001720664'}], 'overallOfficials': [{'name': 'Mohamed Zaghloul, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'mszagh@yahoo.com'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cairo University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Mohamed s. Zaghloul', 'investigatorAffiliation': 'Cairo University'}}}}