PETRA2 - CRC: PET/CT Scan as a Tool to Rationalize the Treatment of Patients With Advanced ColoRectal Cancer Undergoing First-line Medical Treatment
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Other: Advanced CRC patients undergoing first-line chemotherapy single cohort |
Procedure: PET/CT
PET/CT scan at baseline and 10-14 days after day 1 of first cycle chemotherapy
Drug: first-line chemotherapy
as prescribed by oncologist
|
Outcome Measures
Primary Outcome Measures
- change from baseline in highest value SUVmax (maximum standardized uptake values in PET/CT scan) [2 weeks]
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
Secondary Outcome Measures
- Change from baseline in SUVmaxsum, TLGmax and TLGmaxsum [one year]
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).
- correlation among SUVmax, SUVmaxsum, TLGmax, TLGsum with progression-free survival after first-line pharmacologic therapy [one year]
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
- correlation among SUVmax, SUVmaxsum, TLGmax, TLGsum with objective response [3 months]
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
- prognostic value of metabolic response (SUVmax, SUVmaxsum, TLGmax, TLGsum) and recist response [one year]
Other Outcome Measures
- prognostic value of metabolic response (SUVmax, SUVmaxsum, TLGmax, TLGsum) by different cut off values (other than 50% reduction) [one year]
Eligibility Criteria
Criteria
Inclusion Criteria:
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Diagnosis histologically confirmed colorectal carcinoma
-
stage IV disease
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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.
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At least one target or non-target lesion according to RECIST revised version 1.1.
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Age > or = 18 years .
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ECOG PS 0-2.
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Life expectancy > 3 months.
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Signed informed consent.
Exclusion Criteria:
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Uncontrolled diabetes (glucose > 200 mg/dl
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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).
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Pregnant or lactating females.
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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).
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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
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Inability to provide informed consent.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Istituto Nazionale dei Tumori | Napoli | Italy |
Sponsors and Collaborators
- National Cancer Institute, Naples
Investigators
- Principal Investigator: Secondo Lastoria, M.D., National Cancer Institute, Naples
- Principal Investigator: Francesco Perrone, M.D., Ph.D, National Cancer Institute Naples, Italy; Director Clinical Trials Unit
- Principal Investigator: Ciro Gallo, M.D., Ph.D, Second University of Naples, Italy; Chair of Medical Statistics
- Principal Investigator: Luigi Aloj, M.D., National Cancer Institute, Naples
- Principal Investigator: Corradina Caracò, M.D., National Cancer Institute, Naples
- Principal Investigator: Vincenzo Iaffaioli, M.D., National Cancer Institute, Naples
- Principal Investigator: Guglielmo Nasti, M.D., National Cancer Institute, Naples
- Principal Investigator: Antonio Avallone, M.D., National Cancer Institute, Naples
- Principal Investigator: Giovanni Romano, M.D., National Cancer Institute, Naples
- Principal Investigator: Paolo Delrio, M.D., National Cancer Institute, Naples
- Principal Investigator: Francesco Izzo, M.D., National Cancer Institute, Naples
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- PETRA2 - CRC