Ignite Creation Date:
2025-12-24 @ 6:43 PM
Ignite Modification Date:
2025-12-28 @ 3:25 PM
Study NCT ID:
NCT05622357
Status:
COMPLETED
Last Update Posted:
2022-11-18
First Post:
2022-11-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Prospective Study of Short Course Radiation Therapy Followed by Neoadjuvant Chemotherapy and Surgery in Locally Advanced Rectal Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 51}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-03-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-11', 'completionDateStruct': {'date': '2021-09-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-11-11', 'studyFirstSubmitDate': '2022-11-11', 'studyFirstSubmitQcDate': '2022-11-11', 'lastUpdatePostDateStruct': {'date': '2022-11-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-11-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-12-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'pathological complete response (pCR)', 'timeFrame': 'within 30 days', 'description': 'No residual disease in surgical specimen'}, {'measure': 'clinical complete response(cCR)', 'timeFrame': 'within 30 days', 'description': 'No residual disease after end of radiation and chemotherapy by examination,imaging and colonoscopy'}, {'measure': 'Sphincter saving surgery', 'timeFrame': 'within 6 months', 'description': 'Patients who were deemed abdomino-perineal resection before treatment start \\& were able to undergo low anterior resection after end of treatment'}], 'secondaryOutcomes': [{'measure': 'Local control', 'timeFrame': '3 years', 'description': 'defined as the period calculated from the date of end of treatment to the date of occurrence of loco-regional failure.'}, {'measure': 'Overall survival', 'timeFrame': '3 years', 'description': 'defined as period from diagnosis till last follow up or death from any cause'}, {'measure': 'Disease free survival', 'timeFrame': 'within 3 years', 'description': 'defined as the period calculated from the date of end of treatment to the date of occurrence of loco-regional failure or distant failure, whichever comes first.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['advanced rectal cancer- short course radiation - chemotherapy-surgery'], 'conditions': ['Locally Advanced Rectal Carcinoma']}, 'descriptionModule': {'briefSummary': 'The goal of this clinical trial is to investigate total neoadjuvant therapy (TNT) using short course radiation therapy (SCRT) followed by full course of chemotherapy then surgery in locally advanced rectal cancer. The main questions it aims to answer are:\n\n* Is total neoadjuvant treatment in this design safe \\& tolerable?\n* Impact of this design on treatment related outcomes in terms of pathological and clinical responses.', 'detailedDescription': 'Patients will be assigned to an experimental arm in which preoperative short course 5 x 5 Gy radiation therapy is followed by six cycles of combination chemotherapy (capecitabine and oxaliplatin) and surgery within 4-6 weeks'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Histopathological proof of rectal adenocarcinoma.\n* Tumors located within 15 cm and not less than 4 cm from anal verge.\n* Age: ≥ 18 years.\n* Locally advanced resectable rectal cancer (cT3/4 N0- Any T N+ve).\n* ECOG Performance Status: 0-2.\n\nExclusion Criteria:\n\n* Non-epithelial rectal malignancy such as sarcoma or lymphoma.\n* Unresectable tumors in which surgery will never be possible even if substantial tumor downsizing is seen.\n* Recurrent rectal cancer.\n* Previous history of malignancy within the last 5 years.\n* Previous pelvic irradiation.\n* Psychiatric or addictive disorder that would preclude study therapy.\n* Concurrent uncontrolled medical conditions.\n* Pregnancy or breast feeding.\n* Any contraindication to surgery.\n* Extensive peripheral neuropathy.'}, 'identificationModule': {'nctId': 'NCT05622357', 'briefTitle': 'Prospective Study of Short Course Radiation Therapy Followed by Neoadjuvant Chemotherapy and Surgery in Locally Advanced Rectal Cancer', 'organization': {'class': 'OTHER', 'fullName': 'National Cancer Institute, Egypt'}, 'officialTitle': 'Prospective Phase II Study of Hypofractionated Short Course Radiation Therapy Followed by Neoadjuvant Chemotherapy and Surgery in Locally Advanced Rectal Cancer', 'orgStudyIdInfo': {'id': '201617097'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Short course RT followed by full course of chemotherapy then surgery', 'description': 'Short course radiation therapy ( 25 Gy/ 5 fractions/ 1 week) , followed by 6 cycles of chemotherapy CAPOX, followed 4-6 weeks by surgery.', 'interventionNames': ['Radiation: short course radiation therapy followed by 6 cycles of CAPOX then surgery']}], 'interventions': [{'name': 'short course radiation therapy followed by 6 cycles of CAPOX then surgery', 'type': 'RADIATION', 'description': 'Short course RT 5 x5 Gy followed by 6 cycles CAPOX then surgery', 'armGroupLabels': ['Short course RT followed by full course of chemotherapy then surgery']}]}, 'contactsLocationsModule': {'locations': [{'zip': '11796', 'city': 'Cairo', 'state': 'الجيزة', 'country': 'Egypt', 'facility': 'National Cancer Institute', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Cancer Institute, Egypt', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Lecturer of Radiation Oncology', 'investigatorFullName': 'Yasser Anwar', 'investigatorAffiliation': 'National Cancer Institute, Egypt'}}}}