PET/CT Scan as a Tool to Rationalize the Treatment of Patients With Advanced ColoRectal Cancer Undergoing First-line Medical Treatment

Study Overview
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Brief Summary
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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.

Official Title
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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)

Conditions
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Colorectal Cancer Stage IV

Intervention / Treatment
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* Procedure: PET/CT
* Drug: first-line chemotherapy


Participation Criteria
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Eligibility Criteria
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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 1.1. Age > or = 18 years . ECOG PS 0-2. 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Advanced CRC patients undergoing first-line chemotherapy<br>single cohort | Procedure: PET/CT<br>* PET/CT scan at baseline and 10-14 days after day 1 of first cycle chemotherapy<br>Drug: first-line chemotherapy<br>* as prescribed by oncologist<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change from baseline in highest value SUVmax (maximum standardized uptake values in PET/CT scan) | 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 | 2 weeks | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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PET, metabolic response, chemotherapy