PET/CT Scan as a Tool to Rationalize the Treatment of Patients With Advanced ColoRectal Cancer Undergoing First-line Medical Treatment (PETRA2 - CRC)

National Cancer Institute, Naples

Status

Active, not recruiting

Conditions

Colorectal Cancer Stage IV

Treatments

Procedure: PET/CT

Drug: first-line chemotherapy

Study type

Interventional

Funder types

Other

Identifiers

NCT02618850

PETRA2 - CRC

Details and patient eligibility

About

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.

Enrollment

260 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.