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

March 23, 2023 updated by: National Cancer Institute, Naples

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)

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

260

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Napoli, Italy
        • Istituto Nazionale dei Tumori

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
change from baseline in highest value SUVmax (maximum standardized uptake values in PET/CT scan)
Time Frame: 2 weeks
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
Time Frame: one year
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
Time Frame: one year
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
Time Frame: 3 months
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
Time Frame: one year
one year

Other Outcome Measures

Outcome Measure
Time Frame
prognostic value of metabolic response (SUVmax, SUVmaxsum, TLGmax, TLGsum) by different cut off values (other than 50% reduction)
Time Frame: one year
one year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Cancer Institute, Naples

Investigators

  • Principal Investigator: Secondo Lastoria, M.D., National Cancer Institute, Naples
  • 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: 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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2014

Primary Completion (Anticipated)

December 1, 2024

Study Completion (Anticipated)

December 1, 2024

Study Registration Dates

First Submitted

April 13, 2015

First Submitted That Met QC Criteria

November 27, 2015

First Posted (Estimate)

December 2, 2015

Study Record Updates

Last Update Posted (Actual)

March 24, 2023

Last Update Submitted That Met QC Criteria

March 23, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PETRA2 - CRC

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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