Clinical trial NCT02618850: PET/CT Scan as a Tool to Rationalize the Treatment of Patients With Advanced ColoRectal Cancer Undergoing First-line Medical Treatment
Official title: 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)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Colorectal Cancer Stage IV
Keywords: metabolic response
chemotherapy
PET
Lead sponsor: National Cancer Institute, Naples
Sponsor class: OTHER
First posted: 2015-12-02
Enrollment: 260
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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 1.1.
* 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.

Primary outcomes:
measure: change from baseline in highest value SUVmax (maximum standardized uptake values in PET/CT scan)
timeFrame: 2 weeks
Secondary outcomes:
measure: Change from baseline in SUVmaxsum, TLGmax and TLGmaxsum
timeFrame: one year
measure: correlation among SUVmax, SUVmaxsum, TLGmax, TLGsum with progression-free survival after first-line pharmacologic therapy
timeFrame: one year
measure: correlation among SUVmax, SUVmaxsum, TLGmax, TLGsum with objective response
timeFrame: 3 months
measure: prognostic value of metabolic response (SUVmax, SUVmaxsum, TLGmax, TLGsum) and recist response
timeFrame: one year
Other outcomes:
measure: prognostic value of metabolic response (SUVmax, SUVmaxsum, TLGmax, TLGsum) by different cut off values (other than 50% reduction)
timeFrame: one year
Locations:
city: Napoli
country: Italy
facility: Istituto Nazionale dei Tumori
Study officials:
affiliation: National Cancer Institute, Naples
name: Secondo Lastoria, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: National Cancer Institute Naples, Italy; Director Clinical Trials Unit
name: Francesco Perrone, M.D., Ph.D
role: PRINCIPAL_INVESTIGATOR
affiliation: Second University of Naples, Italy; Chair of Medical Statistics
name: Ciro Gallo, M.D., Ph.D
role: PRINCIPAL_INVESTIGATOR
affiliation: National Cancer Institute, Naples
name: Luigi Aloj, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: National Cancer Institute, Naples
name: Corradina Caracò, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: National Cancer Institute, Naples
name: Vincenzo Iaffaioli, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: National Cancer Institute, Naples
name: Guglielmo Nasti, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: National Cancer Institute, Naples
name: Antonio Avallone, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: National Cancer Institute, Naples
name: Giovanni Romano, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: National Cancer Institute, Naples
name: Paolo Delrio, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: National Cancer Institute, Naples
name: Francesco Izzo, M.D.
role: PRINCIPAL_INVESTIGATOR
References: