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

NCT02618850 | Unknown

• 1 other identifier: PETRA2 - CRC
• Study Type: interventional
• Target: 260
• Locations: 1 country
• Sites: 1

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.

Conditions

Colorectal Cancer Stage IV

Keywords

metabolic response; chemotherapy; PET

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• 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

Other Outcomes (1)

• prognostic value of metabolic response (SUVmax, SUVmaxsum, TLGmax, TLGsum) by different cut off values (other than 50% reduction)

  one year

Study Arms (1)

Advanced CRC patients undergoing first-line chemotherapy

OTHER

single cohort

Procedure: PET/CT; Drug: first-line chemotherapy

Interventions

PET/CT PROCEDURE

PET/CT scan at baseline and 10-14 days after day 1 of first cycle chemotherapy

Advanced CRC patients undergoing first-line chemotherapy

first-line chemotherapy DRUG

as prescribed by oncologist

Advanced CRC patients undergoing first-line chemotherapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• National Cancer Institute, Naples: lead

Study Sites (1)

Istituto Nazionale dei Tumori

Napoli, Italy

Location

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

• Paolo Delrio, M.D.

  National Cancer Institute, Naples

  PRINCIPAL INVESTIGATOR

• Francesco Izzo, M.D.

  National Cancer Institute, Naples

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 13, 2015
• First Posted: December 2, 2015
• Study Start: April 1, 2014
• Primary Completion: December 1, 2024
• Study Completion: December 1, 2024
• Last Updated: March 24, 2023

Record last verified: 2023-03

Locations

IT (1)