PET/CT Scan as a Tool to Rationalize the Treatment of Patients With Advanced ColoRectal Cancer Undergoing First-line Medical Treatment
NCT ID: NCT02618850
Last Updated: 2023-03-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
260 participants
INTERVENTIONAL
2014-04-30
2024-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Advanced CRC patients undergoing first-line chemotherapy
single cohort
PET/CT
PET/CT scan at baseline and 10-14 days after day 1 of first cycle chemotherapy
first-line chemotherapy
as prescribed by oncologist
Interventions
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PET/CT
PET/CT scan at baseline and 10-14 days after day 1 of first cycle chemotherapy
first-line chemotherapy
as prescribed by oncologist
Eligibility Criteria
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Inclusion Criteria
* stage IV disease
* 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.
* At least one target or non-target lesion according to RECIST revised version 1.1.
* Age \> or = 18 years .
* ECOG PS 0-2.
* Life expectancy \> 3 months.
* Signed informed consent.
Exclusion Criteria
* 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).
* Pregnant or lactating females.
* 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).
* 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
* Inability to provide informed consent.
18 Years
ALL
No
Sponsors
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National Cancer Institute, Naples
OTHER
Responsible Party
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Principal Investigators
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Secondo Lastoria, M.D.
Role: PRINCIPAL_INVESTIGATOR
National Cancer Institute, Naples
Francesco Perrone, M.D., Ph.D
Role: PRINCIPAL_INVESTIGATOR
National Cancer Institute Naples, Italy; Director Clinical Trials Unit
Ciro Gallo, M.D., Ph.D
Role: PRINCIPAL_INVESTIGATOR
Second University of Naples, Italy; Chair of Medical Statistics
Luigi Aloj, M.D.
Role: PRINCIPAL_INVESTIGATOR
National Cancer Institute, Naples
Corradina Caracò, M.D.
Role: PRINCIPAL_INVESTIGATOR
National Cancer Institute, Naples
Vincenzo Iaffaioli, M.D.
Role: PRINCIPAL_INVESTIGATOR
National Cancer Institute, Naples
Guglielmo Nasti, M.D.
Role: PRINCIPAL_INVESTIGATOR
National Cancer Institute, Naples
Antonio Avallone, M.D.
Role: PRINCIPAL_INVESTIGATOR
National Cancer Institute, Naples
Giovanni Romano, M.D.
Role: PRINCIPAL_INVESTIGATOR
National Cancer Institute, Naples
Paolo Delrio, M.D.
Role: PRINCIPAL_INVESTIGATOR
National Cancer Institute, Naples
Francesco Izzo, M.D.
Role: PRINCIPAL_INVESTIGATOR
National Cancer Institute, Naples
Locations
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Istituto Nazionale dei Tumori
Napoli, , Italy
Countries
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Other Identifiers
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PETRA2 - CRC
Identifier Type: -
Identifier Source: org_study_id
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