Ignite Creation Date:
2025-12-24 @ 3:42 PM
Ignite Modification Date:
2025-12-31 @ 9:37 PM
Study NCT ID:
NCT01224392
Status:
COMPLETED
Last Update Posted:
2020-12-30
First Post:
2010-06-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Simultaneous Integrated Boost Preoperative Radiotherapy for Rectum Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012004', 'term': 'Rectal Neoplasms'}, {'id': 'D015179', 'term': 'Colorectal Neoplasms'}], 'ancestors': [{'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': 'D003108', 'term': 'Colonic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D059248', 'term': 'Chemoradiotherapy'}, {'id': 'D000069287', 'term': 'Capecitabine'}, {'id': 'D011878', 'term': 'Radiotherapy'}], 'ancestors': [{'id': 'D003131', 'term': 'Combined Modality Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D004358', 'term': 'Drug Therapy'}, {'id': 'D003841', 'term': 'Deoxycytidine'}, {'id': 'D003562', 'term': 'Cytidine'}, {'id': 'D011741', 'term': 'Pyrimidine Nucleosides'}, {'id': 'D011743', 'term': 'Pyrimidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D005472', 'term': 'Fluorouracil'}, {'id': 'D014498', 'term': 'Uracil'}, {'id': 'D011744', 'term': 'Pyrimidinones'}, {'id': 'D003853', 'term': 'Deoxyribonucleosides'}, {'id': 'D009705', 'term': 'Nucleosides'}, {'id': 'D009706', 'term': 'Nucleic Acids, Nucleotides, and Nucleosides'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 156}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-12', 'completionDateStruct': {'date': '2020-11-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-12-28', 'studyFirstSubmitDate': '2010-06-28', 'studyFirstSubmitQcDate': '2010-10-19', 'lastUpdatePostDateStruct': {'date': '2020-12-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2010-10-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2020-11-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'reduction in metabolic tumor activity', 'timeFrame': 'at baseline and at 5 to 6 weeks after neo-adjuvant therapy'}], 'secondaryOutcomes': [{'measure': 'histological downgrading (Dworak classification)', 'timeFrame': 'after the rectum surgery', 'description': 'pathological evaluation of surgical resection specimens'}, {'measure': 'number of R0, R1 and R2 resections', 'timeFrame': 'after the rectum surgery', 'description': 'pathological evaluation of surgical resection specimens'}, {'measure': 'acute and late toxicity, according to the National Cancer Institute (NCI) - Common Terminology Criteria for Adverse Events v3.0 (CTCAE)', 'timeFrame': 'at baseline, every 6 months after completion of radiotherapy and then yearly until 3 years'}, {'measure': 'local control', 'timeFrame': 'every 6 months in the first year after completion of radiotherapy and then yearly until 3 years'}, {'measure': 'progression free survival', 'timeFrame': 'every 6 months in the first year after completion of radiotherapy and then yearly until 3 years'}, {'measure': 'survival', 'timeFrame': 'every 6 months in the first year after completion of radiotherapy and then yearly until 3 years', 'description': 'overall survival'}, {'measure': 'quality of life', 'timeFrame': 'at baseline, every 6 months in the first year after completion of radiotherapy and then yearly until 3 years'}, {'measure': 'cost evaluation', 'timeFrame': 'during the treatment and follow-ups'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['colorectal cancer', 'colorectal neoplasms', 'radiotherapy', 'chemoradiotherapy', 'T3-4 rectal cancer'], 'conditions': ['Rectal Cancer']}, 'descriptionModule': {'briefSummary': 'The investigators propose a randomized non-inferiority trial that compares preoperative Fluoro Uracil (FU)-based chemoradiotherapy to radiotherapy with a simultaneous integrated boost. In patients with T3-4 rectal cancer, the latter approach is considered preferential with regard to toxicity and cost. The metabolic response of the tumor, as assessed by 18F-2-Fluoro-2-Deoxyglucose-Positron Emission tomography (18F-FDG PET) or PET-CT, will be used as a surrogate marker of cause specific outcome'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '95 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* histopathologically confirmed rectal adenocarcinoma with an inferior border within 15 cm of the anal verge\n* the tumor has to have evidence of T3 or T4 disease on Magnetic Resonance Imaging (MRI) or endoluminal ultrasound\n\nExclusion Criteria:\n\n* unresectable metastatic disease\n* Eastern Cooperative Oncology Group (ECOG) performance status \\> 3\n* patients not deemed fit for radiotherapy, capecitabine or surgery\n* pregnant or lactating patients\n* women with child bearing potential who lack effective contraception\n* patients below 18 years old'}, 'identificationModule': {'nctId': 'NCT01224392', 'acronym': 'RectumSIB', 'briefTitle': 'Simultaneous Integrated Boost Preoperative Radiotherapy for Rectum Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Universitair Ziekenhuis Brussel'}, 'officialTitle': 'Randomized Trial of Preoperative Radiotherapy With an Integrated Simultaneous Boost Compared to Chemoradiotherapy for T3-4 Rectal Cancer', 'orgStudyIdInfo': {'id': 'RectumSIB'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Concomitant chemoradiotherapy', 'description': 'Radiotherapy (23 x 2 Gy) + capecitabine 825mg/m2 p.o. twice daily, excluding weekends', 'interventionNames': ['Other: Chemoradiotherapy']}, {'type': 'EXPERIMENTAL', 'label': 'Radiotherapy with boost', 'description': 'Radiotherapy (23 x 2 Gy), with a simultaneous integrated boost up to 55.2 Gy on the primary tumor', 'interventionNames': ['Radiation: Radiotherapy with boost']}], 'interventions': [{'name': 'Chemoradiotherapy', 'type': 'OTHER', 'otherNames': ['Xeloda (capecitabine)'], 'description': 'Radiotherapy (23 x 2 Gy) + capecitabine 825mg/m2 p.o. twice daily, excluding weekends', 'armGroupLabels': ['Concomitant chemoradiotherapy']}, {'name': 'Radiotherapy with boost', 'type': 'RADIATION', 'otherNames': ['Preoperative radiotherapy'], 'description': 'Radiotherapy (23 x 2 Gy), with a simultaneous integrated boost up to 55.2 Gy on the primary tumor', 'armGroupLabels': ['Radiotherapy with boost']}]}, 'contactsLocationsModule': {'locations': [{'zip': '9010', 'city': 'Jette', 'state': 'Brussels Capital', 'country': 'Belgium', 'facility': 'UZ Brussel , Vrije Universiteit Brussel, dienst Radiotherapie', 'geoPoint': {'lat': 50.87309, 'lon': 4.33419}}, {'zip': '1090', 'city': 'Jette', 'country': 'Belgium', 'facility': 'UZ Brussel, Vrije Universiteit Brussel, dienst Radiotherapie', 'geoPoint': {'lat': 50.87309, 'lon': 4.33419}}], 'overallOfficials': [{'name': 'Mark De Ridder, Prof.Dr.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'UZ Brussel, Vrije Universiteit Brussel, dienst Radiotherapie'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universitair Ziekenhuis Brussel', 'class': 'OTHER'}, 'collaborators': [{'name': 'Vrije Universiteit Brussel', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Head of Radiotherapy Department', 'investigatorFullName': 'Mark De Ridder', 'investigatorAffiliation': 'Universitair Ziekenhuis Brussel'}}}}