Ignite Creation Date:
2025-12-25 @ 3:02 AM
Ignite Modification Date:
2026-03-03 @ 6:15 AM
Study NCT ID:
NCT03853733
Status:
RECRUITING
Last Update Posted:
2024-10-04
First Post:
2019-02-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Hypofractionated Palliative Radiotherapy in Patients With Advanced Non-operable Rectal Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012004', 'term': 'Rectal Neoplasms'}, {'id': 'D006471', 'term': 'Gastrointestinal Hemorrhage'}], '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'}, {'id': 'D006470', 'term': 'Hemorrhage'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2016-10-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-10', 'completionDateStruct': {'date': '2025-03-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-10-03', 'studyFirstSubmitDate': '2019-02-18', 'studyFirstSubmitQcDate': '2019-02-21', 'lastUpdatePostDateStruct': {'date': '2024-10-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-02-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-03-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Symptomatic response after palliative radiotherapy (bleeding)', 'timeFrame': 'two months afer the end of radiotherapy', 'description': 'number of patients with bleeding ( worst, no change, better or without)'}, {'measure': 'Symptomatic response after palliative radiotherapy (pain)', 'timeFrame': 'two months afer the end of radiotherapy', 'description': 'number of patients with pain ( worst, no change, better or without)'}, {'measure': 'Gastrointestinal toxicity after the end of radiotherapy', 'timeFrame': 'two months afer the end of radiotherapy', 'description': 'Gastrointestinal toxicity after the end of radiotherapy were reported according to CTCAE v4.0 scale'}, {'measure': 'Genitourinary toxicity after the end of radiotherapy', 'timeFrame': 'two months afer the end of radiotherapy', 'description': 'Genitourinary toxicity after the end of radiotherapy were reported according to CTCAE v4.0 scale.'}], 'secondaryOutcomes': [{'measure': 'palliative colostomy after the end of palliative radiotherapy', 'timeFrame': 'two months afer the end of radiotherapy', 'description': 'number of patients with colostomy'}]}, 'conditionsModule': {'keywords': ['palliative radiotherapy', 'rectal bleeding', 'hypofractionated radiotherapy'], 'conditions': ['Rectal Cancer']}, 'referencesModule': {'references': [{'type': 'BACKGROUND', 'citation': 'EP-1648: Palliative hipofractionated radiotherapy in non operable rectal cancer: preliminary results RSS Download PDF J. Lozano Galan, E. Rubio and J. Solé Radiotherapy and Oncology, 2018-04-01, Volume 127, Pages S887-S887'}]}, 'descriptionModule': {'briefSummary': 'Many patients with rectal cancer were not candidates for surgical resection because advanced age, comorbidities, or multiple synchronous metastases. In this scenario only comfort measures or different palliative radiotherapy regimens are applied, from single doses to treatments lasting several weeks. The aim of this prospective study is to describe the preliminary results of our protocol of hypofractionated palliative radiotherapy in patients with non-operable rectal cancer.', 'detailedDescription': 'Many patients with rectal cancer were not candidates for surgical resection because advanced age, comorbidities, or multiple synchronous metastases. In this scenario only comfort measures or different palliative radiotherapy regimens are applied, from single doses to treatments lasting several weeks. The aim of this prospective study is to describe the preliminary results of our protocol of hypofractionated palliative radiotherapy in patients with non-operable rectal cancer.\n\nPatients with rectal cancer who were not candidates for surgical resection because advanced age, comorbidities, or multiple synchronous metastases at the time of diagnosis were considered eligible.\n\nPatients were immobilized in the prone position with a belly-board in order to reduce small bowel irradiation. To limit organ motion patient were instructed to empty the bladder and drink 500cm3 of water 45-60 minutes before CT simulation and before every treatment fraction.\n\nA conformal three-dimensional radiotherapy technique was planned to deliver to the primary tumor and the enlarged pelvic nodes a total dose of 39Gy in 13 sessions of 3Gy in 17 days.\n\nSymptomatic response after the end of treatment has been measured for bleeding and pain and acute toxicity were reported according to CTCAEv4.0 scale.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with rectal cancer who were not candidates for surgical resection because advanced age, comorbidities, or multiple synchronous metastases at the time of diagnosis.', 'eligibilityCriteria': 'Inclusion criteria :\n\n1. Patients with rectal or sigmoidal cancer who were not candidates for surgical resection because advanced age, comorbidities, or multiple synchronous metastases at the time of diagnosis\n2. Patients with = or \\> 18 years old\n3. Patients treated with a radiotherapy dose of 39Gy in 13 fractions of 3 Gy\n\nExclusion criteria:\n\n1. Patients with a non rectum or sigma colo-rectal cancer.\n2. Patients with \\<18 years old.\n3. Patients treated with concurrent chemotherapy\n4. Patients candidates for surgical resection after radiotherapy'}, 'identificationModule': {'nctId': 'NCT03853733', 'briefTitle': 'Hypofractionated Palliative Radiotherapy in Patients With Advanced Non-operable Rectal Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Consorci Sanitari de Terrassa'}, 'officialTitle': 'Palliative Hypofractionated Radiotherapy in Non-operable Rectal Cancer: A Retrospective Study', 'orgStudyIdInfo': {'id': 'ONCORTCST2019-2'}}, 'armsInterventionsModule': {'interventions': [{'name': 'rectal cancer radiotherapy', 'type': 'RADIATION', 'description': 'Conformal three-dimensional radiotherapy to deliver to the primary tumor and the enlarged pelvic nodes a total dose of 39Gy in 13 sessions of 3Gy in 17 days.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '08227', 'city': 'Terrassa', 'state': 'Catalonia', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Joan Lozano, MD', 'role': 'CONTACT', 'email': 'jlozano@cst.cat', 'phone': '+34 937003690'}, {'name': 'Joan Lozano, MD', 'role': 'CONTACT', 'email': 'jlozano@cst.cat', 'phone': '34 937003690'}], 'facility': 'Consorci Sanitari de Terrassa', 'geoPoint': {'lat': 41.56667, 'lon': 2.01667}}], 'centralContacts': [{'name': 'Joan Lozano, MD', 'role': 'CONTACT', 'email': 'jlozano@cst.cat', 'phone': '+34 937003690'}, {'name': 'Joan Lozano, MD', 'role': 'CONTACT', 'email': 'jlozano@comb.cat', 'phone': '+34 937003690'}], 'overallOfficials': [{'name': 'Joan Lozano, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Consorci Sanitari de Terrassa'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Consorci Sanitari de Terrassa', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Joan Lozano Galan', 'investigatorAffiliation': 'Consorci Sanitari de Terrassa'}}}}