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)

National Cancer Institute, Naples1 site in 1 country260 target enrollmentApril 2014

ConditionsColorectal Cancer Stage IV

InterventionsPET/CT first-line chemotherapy

Drugsfirst-line chemotherapy

Overview

Phase: Not Applicable
Intervention: PET/CT
Conditions: Colorectal Cancer Stage IV
Sponsor: National Cancer Institute, Naples
Enrollment: 260
Locations: 1
Primary Endpoint: change from baseline in highest value SUVmax (maximum standardized uptake values in PET/CT scan)
Status: Active, not recruiting
Last Updated: 3 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

April 2014

End Date

December 2024

Last Updated

3 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

National Cancer Institute, Naples

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Diagnosis histologically confirmed colorectal carcinoma
•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.
•Age \> or = 18 years .
•ECOG PS 0-
•Life expectancy \> 3 months.
•Signed informed consent.

Exclusion Criteria

•Uncontrolled diabetes (glucose \> 200 mg/dl
•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.

Arms & Interventions

Advanced CRC patients undergoing first-line chemotherapy

single cohort

Intervention: PET/CT

Advanced CRC patients undergoing first-line chemotherapy

single cohort

Intervention: first-line chemotherapy

Outcomes

Primary Outcomes

change from baseline in highest value SUVmax (maximum standardized uptake values in PET/CT scan)

Time Frame: 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 Outcomes

Change from baseline in SUVmaxsum, TLGmax and TLGmaxsum(one year)
correlation among SUVmax, SUVmaxsum, TLGmax, TLGsum with progression-free survival after first-line pharmacologic therapy(one year)
correlation among SUVmax, SUVmaxsum, TLGmax, TLGsum with objective response(3 months)
prognostic value of metabolic response (SUVmax, SUVmaxsum, TLGmax, TLGsum) and recist response(one year)