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

Primary Purpose

Colorectal Cancer Stage IV

Status

Active

Phase

Not Applicable

Locations

Italy

Study Type

Interventional

Intervention

PET/CT

first-line chemotherapy

About this trial

This is an interventional treatment trial for Colorectal Cancer Stage IV focused on measuring metabolic response, chemotherapy, PET

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

Istituto Nazionale dei Tumori

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Advanced CRC patients undergoing first-line chemotherapy

Arm Description

single cohort

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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).

correlation among SUVmax, SUVmaxsum, TLGmax, TLGsum with progression-free survival after first-line pharmacologic therapy

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

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

prognostic value of metabolic response (SUVmax, SUVmaxsum, TLGmax, TLGsum) and recist response

Full Information

NCT ID

NCT02618850

First Posted

April 13, 2015

Last Updated

March 23, 2023

Sponsor

National Cancer Institute, Naples

1. Study Identification

Unique Protocol Identification Number

NCT02618850

Brief Title

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

Acronym

PETRA2 - CRC

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

2. Study Status

Record Verification Date

March 2023

Overall Recruitment Status

Active, not recruiting

Study Start Date

April 2014 (undefined)

Primary Completion Date

December 2024 (Anticipated)

Study Completion Date

December 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

National Cancer Institute, Naples

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Colorectal Cancer Stage IV

Keywords

metabolic response, chemotherapy, PET

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

260 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Advanced CRC patients undergoing first-line chemotherapy

Arm Type

Other

Arm Description

single cohort

Intervention Type

Procedure

Intervention Name(s)

PET/CT

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

first-line chemotherapy

Intervention Description

as prescribed by oncologist

Primary Outcome Measure Information:

Title

change from baseline in highest value SUVmax (maximum standardized uptake values in PET/CT scan)

Description

Time Frame

2 weeks

Secondary Outcome Measure Information:

Title

Change from baseline in SUVmaxsum, TLGmax and TLGmaxsum

Description

Time Frame

one year

Title

correlation among SUVmax, SUVmaxsum, TLGmax, TLGsum with progression-free survival after first-line pharmacologic therapy

Description

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

Time Frame

one year

Title

correlation among SUVmax, SUVmaxsum, TLGmax, TLGsum with objective response

Description

Time Frame

3 months

Title

prognostic value of metabolic response (SUVmax, SUVmaxsum, TLGmax, TLGsum) and recist response

Time Frame

one year

Other Pre-specified Outcome Measures:

Title

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

Time Frame

one year

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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.

Overall Study Officials: