Ignite Creation Date:
2025-12-25 @ 1:39 AM
Ignite Modification Date:
2025-12-28 @ 10:29 PM
Study NCT ID:
NCT00409994
Status:
COMPLETED
Last Update Posted:
2019-03-18
First Post:
2006-12-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety Study of Rapamycin Administered Before and During Radiotherapy to Treat 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': 'D020123', 'term': 'Sirolimus'}], 'ancestors': [{'id': 'D018942', 'term': 'Macrolides'}, {'id': 'D007783', 'term': 'Lactones'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 44}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-03', 'completionDateStruct': {'date': '2018-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-03-14', 'studyFirstSubmitDate': '2006-12-11', 'studyFirstSubmitQcDate': '2006-12-11', 'lastUpdatePostDateStruct': {'date': '2019-03-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2006-12-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-08-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Phase I: Incidence of severe postoperative complications (grade IV or grade V),', 'timeFrame': 'within the first 6 weeks after surgery'}, {'measure': 'assessed according to CTCv3.0', 'timeFrame': 'within the first 6 weeks after surgery'}, {'measure': 'Phase II: Tumour blood flow assessed CT-PET + CTp', 'timeFrame': 'day 64'}], 'secondaryOutcomes': [{'measure': 'Phase I:Incidence of other acute toxicity, assessed according to CTCv 3.0', 'timeFrame': 'within the first 6 weeks after surgery'}, {'measure': 'Activation status of mTor related and dependent molecules in the tumour', 'timeFrame': 'within the first 6 weeks after surgery'}, {'measure': 'Phase II:Maximum standardised Uptake Value (SUV) of 18F-FDG, assessed bij PET-CT-scan', 'timeFrame': 'day 64'}, {'measure': 'Phase II:Incidence of acute side effects of rapamycin, assessed according to CTCv 4.0', 'timeFrame': 'day 8, 15, 22, 36, 50 and 64'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Colorectal cancer', 'M-tor inhibitor', 'Rapamycin'], 'conditions': ['Rectum Cancer']}, 'descriptionModule': {'briefSummary': 'Investigating the safety and the activity of Rapamycin, administered before and during preoperative radiotherapy in patients with an operable colorectal carcinoma. The phase I dose escalation study will be performed in three steps (2, 4 and 6 mg). Patients entered in phase II will follow the same tolerable treatment regimen as patients in phase I study.', 'detailedDescription': 'Treatment regimen Phase I A daily dose of Rapamycin will be taken during 13 days. At step 1 a dose of 2 mg will be given once a day; at step 2 a dose of 4 mg will be given once a day; at step 3 a dose of 6 mg will be given once a day.\n\nPreoperative radiotherapy (5x 5 Gy) will be administered at day 8-12, followed by TME-surgery at day 15.\n\nPhase II A daily dose of 6 mg Rapamycin will be taken for 14 days (unless the optimal dose found in the phase I study is lower).\n\nPreoperative radiotherapy (5x 5 Gy) will be administered at day 9-15, followed by TME-surgery 7-8 weeks post RT.\n\nSample size Phase I dose-escalation study Minimum 3 eligible patients per step, maximum 6 eligible patients per step. Phase II A total of 47 patients will be entered in this part of the study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Histologically proven rectum cancer\n* UICC TNM I-III\n* WHO performance status 0-2\n* Less than 10% weight loss the last 6 months\n* No recent (\\< 3 months) severe cardiac disease\n* Normal serum bilirubin and serum creatinin\n\nExclusion Criteria:\n\n* Concurrent chemotherapy with radiation\n* History of prior pelvis radiotherapy\n* Recent (\\<3 months) myocardial infarction\n* Uncontrolled infectious disease\n* Concurrent medication known as inhibitors of CYP3A4 susceptible to increase Rapamycin blood concentrations'}, 'identificationModule': {'nctId': 'NCT00409994', 'briefTitle': 'Safety Study of Rapamycin Administered Before and During Radiotherapy to Treat Rectum Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Maastricht Radiation Oncology'}, 'officialTitle': 'A Clinical Trial Testing Rapamycin, an mTOR-inhibitor, in Combination With Preoperative Radiotherapy in Operable Rectum Cancer: a Phase I and Phase II Study', 'orgStudyIdInfo': {'id': '04-16'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Rapamycine', 'description': 'rapamycine 6 mg dd', 'interventionNames': ['Drug: Rapamycin']}], 'interventions': [{'name': 'Rapamycin', 'type': 'DRUG', 'otherNames': ['Sirolimus'], 'description': 'dosis escalation: 2/4/6 mg rapamycin tablets, once daily during 13 days', 'armGroupLabels': ['Rapamycine']}]}, 'contactsLocationsModule': {'locations': [{'zip': '6202 AZ', 'city': 'Maastricht', 'state': 'Limburg', 'country': 'Netherlands', 'facility': 'Maastricht Radiation Oncology', 'geoPoint': {'lat': 50.84833, 'lon': 5.68889}}], 'overallOfficials': [{'name': 'Jeroen Buijsen, MD PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Maastricht Radiation Oncology'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Maastricht Radiation Oncology', 'class': 'OTHER'}, 'collaborators': [{'name': 'Academisch Ziekenhuis Maastricht', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}