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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Advanced CRC patients undergoing first-line chemotherapy | Other | single cohort |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PET/CT | Procedure | PET/CT scan at baseline and 10-14 days after day 1 of first cycle chemotherapy |
|
| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| prognostic value of metabolic response (SUVmax, SUVmaxsum, TLGmax, TLGsum) by different cut off values (other than 50% reduction) | one year |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| 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 |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Istituto Nazionale dei Tumori | Naples | Italy |
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| first-line chemotherapy | Drug | as prescribed by oncologist |
|
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 |
| Paolo Delrio, M.D. | National Cancer Institute, Naples | Principal Investigator |
| Francesco Izzo, M.D. | National Cancer Institute, Naples | Principal Investigator |
| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
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