Ignite Creation Date:
2025-12-24 @ 10:34 PM
Ignite Modification Date:
2026-02-23 @ 1:11 AM
Study NCT ID:
NCT01257035
Status:
TERMINATED
Last Update Posted:
2013-06-17
First Post:
2010-12-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Predictive Value of 18F-FAZA in Rectum 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': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 21}}, 'statusModule': {'whyStopped': "The logistics of this trial (incl. supply of tracer) in connection with the patients' treatment course caused the inclusion rate to be very slow.", 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2010-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-06', 'completionDateStruct': {'date': '2012-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-06-14', 'studyFirstSubmitDate': '2010-12-08', 'studyFirstSubmitQcDate': '2010-12-08', 'lastUpdatePostDateStruct': {'date': '2013-06-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-12-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Response to chemoradiotherapy measured by TRG', 'timeFrame': '8 weeks after chemoradiation treatment'}], 'secondaryOutcomes': [{'measure': 'Recurrence free survival', 'timeFrame': 'From date of inclusion till date of verified recurrence'}, {'measure': 'Survival', 'timeFrame': 'From date of inclusion till date of death by any cause'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Rectum cancer', 'FAZA', '18F-FAZA-PET/CT', 'Radiotherapy', 'Chemoradiotherapy'], 'conditions': ['Locally Advanced Rectum Cancer']}, 'descriptionModule': {'briefSummary': 'The primary purpose of the study is to investigate 18F-FAZA-PETs role as predictor of response to neoadjuvant chemoradiation of locally advanced rectum cancer.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with locally advanced rectum cancer receiving preoperative radiation treatment and concomitant chemotherapy at the Dept. of Oncology, Vejle Hospital.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Histopatologically verified adenocarcinoma in the rectum\n* T4 tumor eller T3 tumor \\< 10 cm from the anus and \\< 5 mm from the mesorectal fascie measured by MR scan. At the distal part of the rectum the distance to the mesorectal fascie is \\< 5 mm and therefore all T3 tumors are included in this area\n* Suitable for preoperative radiation and chemotherapy\n* No distant metastases\n* Age \\>18 years\n* Hematology ANC ≥1.5x10\\^9/l. Thrombocytes ≥ 100x10\\^9/l.\n* Biochemistry Bilirubin ≤ 3 x UNL. ALAT ≤ 5 x UNL\n* Creatinine ≤ UNL\n* Contraception for fertile women\n* Written and orally informed consent\n\nExclusion Criteria:\n\n* Other malignant disease within 5 years, excl. non-melanotic skin cancer\n* Previous radiation treatment of the pelvis\n* Pregnant or breastfeeding women\n* Surgery within 6 weeks prior to enrollment\n* Serious concurrent medical disease\n* Enrollment in study "A prospective observational study of patients with rectum cancer after concomitant radiation and chemotherapy", where the patients are potientially not operated.'}, 'identificationModule': {'nctId': 'NCT01257035', 'acronym': 'FAZA', 'briefTitle': 'Predictive Value of 18F-FAZA in Rectum Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Vejle Hospital'}, 'officialTitle': 'The Predictive Value of 18F-FAZA-PET/CT in Neoadjuvant Radiation for Patients With Locally Advanced Rectum Cancer', 'orgStudyIdInfo': {'id': 'S-20100054'}}, 'armsInterventionsModule': {'armGroups': [{'label': '18F-FAZA-PET/CT', 'interventionNames': ['Other: 18F-FAZA-PET/CT']}], 'interventions': [{'name': '18F-FAZA-PET/CT', 'type': 'OTHER', 'description': 'Contrast fluid injected prior to scan', 'armGroupLabels': ['18F-FAZA-PET/CT']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Vejle', 'country': 'Denmark', 'facility': 'Vejle Hospital', 'geoPoint': {'lat': 55.70927, 'lon': 9.5357}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Vejle Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Aarhus University Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}