Ignite Creation Date:
2025-12-25 @ 3:48 AM
Ignite Modification Date:
2026-02-25 @ 6:52 PM
Study NCT ID:
NCT02603302
Status:
UNKNOWN
Last Update Posted:
2016-06-14
First Post:
2015-11-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Radiation Dose Escalation in Locally Advanced 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': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 48}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2016-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-06', 'completionDateStruct': {'date': '2018-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2016-06-11', 'studyFirstSubmitDate': '2015-11-06', 'studyFirstSubmitQcDate': '2015-11-10', 'lastUpdatePostDateStruct': {'date': '2016-06-14', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-11-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pathologic complete response', 'timeFrame': 'Through study completion, an average of 2 years', 'description': 'Pathologic evaluation of the surgical specimen'}], 'secondaryOutcomes': [{'measure': 'Disease free survival', 'timeFrame': '2 years', 'description': 'Evaluation of disease free survival'}, {'measure': 'Overall survival', 'timeFrame': '2 years', 'description': 'Evaluation of overall survival'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['rectal cancer', 'radiotherapy', 'escalated dose', 'interval'], 'conditions': ['Rectal Cancer']}, 'descriptionModule': {'briefSummary': 'This is a one arm study where patients with locally advanced rectal cancer will receive neoadjuvant treatment with escalated dose radiotherapy (with 3D conformal radiotherapy, up to 59,4 Gy) and radiosensitizing chemotherapy. Then, patients will operated (total mesorectal excision) after 8 weeks of interval. Primary endpoint will be pCR (pathologic complete response).', 'detailedDescription': 'Introduction:\n\nRectal cancer is a highly prevalent disease all over the world. In Brazil, it is the second most common cancer among women (after breast tumors), with an estimated incidence of 17.2 cases per 100,000 inhabitants and is the third most common cancer in men (after prostate and lung cancers), with an estimated incidence of 15.4 cases per 100,000 inhabitants.\n\nGoals:\n\nThe aim of this study is to evaluate the pathologic complete response (pCR) of patients with locally advanced rectal cancer (LARC) treated with neoadjuvant radiochemotherapy (RCT) employing anticancer drugs at standard dose and interval extended to surgery with or without adjuvant neoplastic therapy.\n\nProcedures:\n\nNeoadjuvant chemoradiotherapy with radiation dose escalation associated with radiosensitizing therapy and surgery with a total mesorectal excision (TME), 8 weeks after completing neoadjuvant treatment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Locally advanced rectal cancer, 0-15 cm from anal verge, cT3/4 or cN+\n\nExclusion Criteria:\n\n* Metastatic disease, previous chemotherapy, previous radiotherapy, previous malignant non-skin tumor'}, 'identificationModule': {'nctId': 'NCT02603302', 'acronym': 'RaDE', 'briefTitle': 'Radiation Dose Escalation in Locally Advanced Rectal Cancer', 'organization': {'class': 'OTHER', 'fullName': 'University of Brasilia'}, 'officialTitle': 'Phase II Study of Neoadjuvant Radiotherapy Dose Escalation in Association With Chemotherapy for the Treatment of Locally Advanced Rectal Cancer', 'orgStudyIdInfo': {'id': '01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Locally advanced rectal cancer', 'description': 'RT (3D conformal RT) 45 Gy to the whole pelvis + boost 14.4 Gy to the GTV + Chemotherapy with 5-FU\n\nSurgery 8 weeks after the neoadjvuant treatment.', 'interventionNames': ['Radiation: Dose Escalation Radiotherapy', 'Procedure: Delayed surgery']}], 'interventions': [{'name': 'Dose Escalation Radiotherapy', 'type': 'RADIATION', 'description': 'RT (3D conformal RT) 45 Gy to the whole pelvis + boost 14.4 Gy to the GTV Chemotherapy with 5-FU', 'armGroupLabels': ['Locally advanced rectal cancer']}, {'name': 'Delayed surgery', 'type': 'PROCEDURE', 'description': 'Surgery after 8 weeks with TME (total mesorectal excision)', 'armGroupLabels': ['Locally advanced rectal cancer']}]}, 'contactsLocationsModule': {'locations': [{'zip': '7676105', 'city': 'BrasÃlia', 'state': 'Federal District', 'status': 'RECRUITING', 'country': 'Brazil', 'contacts': [{'name': 'Marcos Santos, MD PHD', 'role': 'CONTACT', 'email': 'marcosrxt@gmail.com', 'phone': '+55 61 83554308'}], 'facility': 'Brasilia Univeristy Hospital', 'geoPoint': {'lat': -15.77972, 'lon': -47.92972}}], 'centralContacts': [{'name': 'Marcos Santos, MD PhD', 'role': 'CONTACT', 'email': 'marcosrxt@gmail.com', 'phone': '+ 55 61 83554308'}], 'overallOfficials': [{'name': 'Marcos Santos, MD PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'BrasÃlia University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES', 'description': 'We may share data in requested by metanalists'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Brasilia', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD PhD', 'investigatorFullName': 'Marcos Santos', 'investigatorAffiliation': 'University of Brasilia'}}}}