Ignite Creation Date:
2025-12-24 @ 5:03 PM
Ignite Modification Date:
2026-04-23 @ 2:00 PM
Study NCT ID:
NCT02618850
Status:
UNKNOWN
Last Update Posted:
2023-03-24
First Post:
2015-04-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
PET/CT Scan as a Tool to Rationalize the Treatment of Patients With Advanced ColoRectal Cancer Undergoing First-line Medical Treatment
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'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': 'D003108', 'term': 'Colonic Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D012002', 'term': 'Rectal Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 260}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2014-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-03', 'completionDateStruct': {'date': '2024-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-03-23', 'studyFirstSubmitDate': '2015-04-13', 'studyFirstSubmitQcDate': '2015-11-27', 'lastUpdatePostDateStruct': {'date': '2023-03-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-12-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2024-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'prognostic value of metabolic response (SUVmax, SUVmaxsum, TLGmax, TLGsum) by different cut off values (other than 50% reduction)', 'timeFrame': 'one year'}], 'primaryOutcomes': [{'measure': 'change from baseline in highest value SUVmax (maximum standardized uptake values in PET/CT scan)', 'timeFrame': '2 weeks', 'description': 'To validate as prognostic factor, in terms of overall survival,early metabolic response, defined as a reduction of more than 50% of the highest value of SUVmax recorded at PET/CT scan after one cycle of chemotherapy, compared to the highest value of SUVmax recorded baseline examination'}], 'secondaryOutcomes': [{'measure': 'Change from baseline in SUVmaxsum, TLGmax and TLGmaxsum', 'timeFrame': 'one year', 'description': 'to describe and validate early metabolic response as a prognostic factor (in terms of progression free survival), using the sum of the SUVmax (SUVmaxsum) , the highest value of TLG (TLGmax), the sum of TLG ( TLGmaxsum).'}, {'measure': 'correlation among SUVmax, SUVmaxsum, TLGmax, TLGsum with progression-free survival after first-line pharmacologic therapy', 'timeFrame': 'one year', 'description': 'prognostic role of early metabolic response (defined according the above reported 4 parameters) in terms of progression free survival after a first line pharmacologic therapy'}, {'measure': 'correlation among SUVmax, SUVmaxsum, TLGmax, TLGsum with objective response', 'timeFrame': '3 months', 'description': 'To describe the association between early metabolic response (defined according the above reported 4 parameters) and objective response according RECIST criteria, measured after 3 cycles of chemotherapy'}, {'measure': 'prognostic value of metabolic response (SUVmax, SUVmaxsum, TLGmax, TLGsum) and recist response', 'timeFrame': 'one year'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['metabolic response', 'chemotherapy', 'PET'], 'conditions': ['Colorectal Cancer Stage IV']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to test whether an early metabolic response, measured by PET/CT scan after the first cycle of chemotherapy, is able to predict which patients with advanced CRC have a better prognosis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Diagnosis histologically confirmed colorectal carcinoma\n* stage IV disease\n* patients eligible for standard first-line treatment medical therapy (chemotherapy, and when indicated in association with EGFR inhibitor and/or antiangiogenic) for advanced disease, at diagnosis or after primary surgery.\n* At least one target or non-target lesion according to RECIST revised version 1.1.\n* Age \\> or = 18 years .\n* ECOG PS 0-2.\n* Life expectancy \\> 3 months.\n* Signed informed consent.\n\nExclusion Criteria:\n\n* Uncontrolled diabetes (glucose \\> 200 mg/dl\n* Any other malignancies within 5 years (except for adequately treated carcinoma in situ of the cervix or basal or squamous cell skin cancer or surgically resected prostate cancer with normal PSA).\n* Pregnant or lactating females.\n* Previous medical therapy for metastatic disease (prior surgery, radiation therapy are permitted, as well as adjuvant medical therapy completed at least 6 months prior to study entry).\n* Any poorly controlled illness (including active infections, significant hepatic, renal, metabolic or cardiac disease, myocardial infarction within previous 12 months) that may, according to physician's judgement, interfere with the patient's ability to undergo chemotherapy and/or the examinations within the study protocol\n* Inability to provide informed consent."}, 'identificationModule': {'nctId': 'NCT02618850', 'acronym': 'PETRA2 - CRC', 'briefTitle': 'PET/CT Scan as a Tool to Rationalize the Treatment of Patients With Advanced ColoRectal Cancer Undergoing First-line Medical Treatment', 'organization': {'class': 'OTHER', 'fullName': 'National Cancer Institute, Naples'}, 'officialTitle': 'Study of the Role of Metabolic Response Measured by PET/CT Scan After 1 Cycle of First-line Therapy in Patients With Advanced Colorectal Cancer (CRC)', 'orgStudyIdInfo': {'id': 'PETRA2 - CRC'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Advanced CRC patients undergoing first-line chemotherapy', 'description': 'single cohort', 'interventionNames': ['Procedure: PET/CT', 'Drug: first-line chemotherapy']}], 'interventions': [{'name': 'PET/CT', 'type': 'PROCEDURE', 'description': 'PET/CT scan at baseline and 10-14 days after day 1 of first cycle chemotherapy', 'armGroupLabels': ['Advanced CRC patients undergoing first-line chemotherapy']}, {'name': 'first-line chemotherapy', 'type': 'DRUG', 'description': 'as prescribed by oncologist', 'armGroupLabels': ['Advanced CRC patients undergoing first-line chemotherapy']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Napoli', 'country': 'Italy', 'facility': 'Istituto Nazionale dei Tumori', 'geoPoint': {'lat': 40.87618, 'lon': 14.5195}}], 'overallOfficials': [{'name': 'Secondo Lastoria, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'National Cancer Institute, Naples'}, {'name': 'Francesco Perrone, M.D., Ph.D', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'National Cancer Institute Naples, Italy; Director Clinical Trials Unit'}, {'name': 'Ciro Gallo, M.D., Ph.D', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Second University of Naples, Italy; Chair of Medical Statistics'}, {'name': 'Luigi Aloj, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'National Cancer Institute, Naples'}, {'name': 'Corradina Caracò, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'National Cancer Institute, Naples'}, {'name': 'Vincenzo Iaffaioli, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'National Cancer Institute, Naples'}, {'name': 'Guglielmo Nasti, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'National Cancer Institute, Naples'}, {'name': 'Antonio Avallone, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'National Cancer Institute, Naples'}, {'name': 'Giovanni Romano, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'National Cancer Institute, Naples'}, {'name': 'Paolo Delrio, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'National Cancer Institute, Naples'}, {'name': 'Francesco Izzo, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'National Cancer Institute, Naples'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Cancer Institute, Naples', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}