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

Colorectal Cancer Stage IV Clinical Trial

— 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)

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02618850
• Other study ID #: PETRA2 - CRC
• Status: Active, not recruiting
• Phase: N/A
• Start date: April 2014
• Est. completion date: December 2024

Study information

• Verified date: March 2023
• Source: National Cancer Institute, Naples
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 260
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Colorectal Cancer Stage IV
• Colorectal Neoplasms

Intervention

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

Locations

Country	Name	City	State
Italy	Istituto Nazionale dei Tumori	Napoli

Sponsors (1)

Lead Sponsor	Collaborator
National Cancer Institute, Naples

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	prognostic value of metabolic response (SUVmax, SUVmaxsum, TLGmax, TLGsum) by different cut off values (other than 50% reduction)		one year
Primary	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	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).	one year
Secondary	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	one year
Secondary	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	3 months
Secondary	prognostic value of metabolic response (SUVmax, SUVmaxsum, TLGmax, TLGsum) and recist response		one year