Ignite Creation Date:
2025-12-24 @ 9:19 PM
Ignite Modification Date:
2025-12-25 @ 7:06 PM
Study NCT ID:
NCT03541304
Status:
COMPLETED
Last Update Posted:
2023-04-14
First Post:
2018-05-18
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
High Dose Radiotherapy for the Treatment of Rectal Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012004', 'term': 'Rectal Neoplasms'}], 'ancestors': [{'id': 'D015179', 'term': 'Colorectal Neoplasms'}, {'id': 'D007414', 'term': 'Intestinal Neoplasms'}, {'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D012002', 'term': 'Rectal Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 48}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-04', 'completionDateStruct': {'date': '2021-12-16', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-04-13', 'studyFirstSubmitDate': '2018-05-18', 'studyFirstSubmitQcDate': '2018-05-18', 'lastUpdatePostDateStruct': {'date': '2023-04-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-05-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-03-16', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'clinical response rate', 'timeFrame': 'evaluate 5 weeks after radiotherapy', 'description': 'the rate of clinical response in the whole group'}], 'secondaryOutcomes': [{'measure': 'short term and long term side effects', 'timeFrame': 'from the complete to 3 years after treatment', 'description': 'short term and long term toxicity related to high dose radiotherapy'}, {'measure': 'progression free survival', 'timeFrame': '3 years', 'description': 'defined as the time from the date of trial entry until disease progression, relapse, or death from any cause.'}, {'measure': 'overall survival', 'timeFrame': '3 years', 'description': 'calculated from the date of trial entry until death from any cause or was censored at last follow-up'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['high dose radiotherapy', 'rectal cancer'], 'conditions': ['Rectal Cancer']}, 'descriptionModule': {'briefSummary': 'While surgery remains the standard treatment for rectal cancer, some patients still firmly refuse surgery for various reasons. Here, we conducted this retrospective observation study to discuss the feasibility of high-dose radiotherapy combined with chemotherapy in treating rectal cancer We retrospectively collect data of rectal cancer patients who were treated with high-dose radiotherapy plus chemotherapy in Sun Yat-sen University Cancer Center from April 1st, 2006 to July 30th, 2017. Patients gave up surgery before any treatment would have received one course of high dose radiotherapy (GTV60-70Gy/30-35f). Patients with tumor residual after neoadjuvant chemoradiotherapy but insisted non-operative treatment would have received 2 courses of radiotherapy (1st: GTV 45-50Gy/25f, 2nd: GTV 30/15f). The chemotherapy regimens included Capox, FOLFOX, or capecitabine at the discretion of the treating physician.\n\nAfter treatment, patients were followed every 3 months for the first two years, at least every 6 months in the year thereafter. Recurrence, early and late toxicity were recorded.\n\nAnalyses were performed using SPSS software, version 19.0 (SPSS, Chicago, IL). Local recurrence and distant metastasis rate, progression free survival, and overall survival were calculated using the Kaplan Meier Method and were compared by log-rank test.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'This retrospective study included subjects identified from the database of the Sun Yat-sen University Cancer Center in the period of April 2006 to July 2017.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. pathologically confirmed diagnosis of rectal adenocarcinoma located within 15cm from the anal verge;\n2. pelvic radiation with a total dose ≥60Gy for the treatment of rectal cancer;\n3. refused surgery as the initial treatment;\n4. a complete set of clinical information and follow-up data.\n\nExclusion Criteria:\n\n1. patients with terminal cancer who received palliative treatment;\n2. patients received any treatment before admission to Sun Yat-sen University Cancer Center;\n3. patients with second primary cancer.'}, 'identificationModule': {'nctId': 'NCT03541304', 'briefTitle': 'High Dose Radiotherapy for the Treatment of Rectal Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Sun Yat-sen University'}, 'officialTitle': 'Efficacy and Toxicity of High Dose Radiotherapy Wich Concurrent Chemotherapy for the Treatment of Rectal Cancer', 'orgStudyIdInfo': {'id': '2018-FXY-079'}}, 'contactsLocationsModule': {'locations': [{'zip': '510060', 'city': 'Guangzhou', 'state': 'Guangdong', 'country': 'China', 'facility': 'Sun Yat-sen University Cancer Center', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sun Yat-sen University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Yuan-hong Gao', 'investigatorAffiliation': 'Sun Yat-sen University'}}}}