Colorectal Cancer Stage IVPETRA2 - CRCNCT02618850
PET/CT Scan as a Tool to Rationalize the Treatment of Patients With Advanced ColoRectal Cancer Undergoing First-line Medical Treatment
A study testing PET/CT and first-line chemotherapy in people with Colorectal Cancer Stage IV, run by National Cancer Institute, Naples at 1 site in Italy.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Cancer Stage IV
- What is being tested?
- PET/CT and first-line chemotherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 260 participants
- Where
- 1 siteItaly
- Study dates
- Apr 2014to Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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)
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
- Being tested
- PET/CT, first-line chemotherapy
- Keywords
- metabolic response, chemotherapy, PET
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PET/CTProcedure or surgery
PET/CT scan at baseline and 10-14 days after day 1 of first cycle chemotherapy
first-line chemotherapyDrug
as prescribed by oncologist
| Study group | Role | What they receive |
|---|---|---|
| Advanced CRC patients undergoing first-line chemotherapy | Other | single cohort Receives: Procedure: PET/CT; Drug: first-line chemotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 2 weeks
Secondary outcomes (4)
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).
Measured: one year
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
Measured: one year
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
Measured: 3 months
prognostic value of metabolic response (SUVmax, SUVmaxsum, TLGmax, TLGsum) and recist response
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2015 (estimated)
- Study startApr 2014
- Primary completionDec 2024 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal Cancer Stage IVStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 260 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute, Naples
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Secondo Lastoria, M.D., Principal investigator, National Cancer Institute, NaplesFrancesco Perrone, M.D., Ph.D, Principal investigator, National Cancer Institute Naples, Italy; Director Clinical Trials UnitCiro Gallo, M.D., Ph.D, Principal investigator, Second University of Naples, Italy; Chair of Medical StatisticsLuigi Aloj, M.D., Principal investigator, National Cancer Institute, NaplesCorradina Caracò, M.D., Principal investigator, National Cancer Institute, NaplesVincenzo Iaffaioli, M.D., Principal investigator, National Cancer Institute, NaplesGuglielmo Nasti, M.D., Principal investigator, National Cancer Institute, NaplesAntonio Avallone, M.D., Principal investigator, National Cancer Institute, Naples
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02618850
- Sponsor's protocol ID
- PETRA2 - CRC
- Acronym
- PETRA2 - CRC
- Status last verified
- Mar 2023
- First submitted
- 13 Apr 2015
- Last updated
- 24 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT02618850
- Acronym / sponsor ID
- PETRA2 - CRC / PETRA2 - CRC
- Conditions
- Colorectal Cancer Stage IV
- Keywords
- metabolic response, chemotherapy, PET
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 260 participants (estimated)
- Lead sponsor
- National Cancer Institute, NaplesUniversity, hospital or other
- Study start
- Apr 2014
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 2 Dec 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Advanced CRC patients undergoing first-line chemotherapy | Other | Procedure: PET/CT, Drug: first-line chemotherapysingle cohort |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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 .
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PET/CTPET/CT scan at baseline and 10-14 days after day 1 of first cycle chemotherapy | Procedure or surgery | Advanced CRC patients undergoing first-line chemotherapy |
| first-line chemotherapyas prescribed by oncologist | Drug | Advanced CRC patients undergoing first-line chemotherapy |
Primary outcome
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
4 secondary outcomes
Change from baseline in SUVmaxsum, TLGmax and TLGmaxsum
Time frame: one year
correlation among SUVmax, SUVmaxsum, TLGmax, TLGsum with progression-free survival after first-line pharmacologic therapy
Time frame: one year
correlation among SUVmax, SUVmaxsum, TLGmax, TLGsum with objective response
Time frame: 3 months
prognostic value of metabolic response (SUVmax, SUVmaxsum, TLGmax, TLGsum) and recist response
Time frame: one year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Secondo Lastoria, M.D. principal investigator
National Cancer Institute, Naples
Francesco Perrone, M.D., Ph.D principal investigator
National Cancer Institute Naples, Italy; Director Clinical Trials Unit
Ciro Gallo, M.D., Ph.D principal investigator
Second University of Naples, Italy; Chair of Medical Statistics
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PET/CT and first-line chemotherapy in people with Colorectal Cancer Stage IV, run by National Cancer Institute, Naples at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change from baseline in highest value SUVmax (maximum standardized uptake values in PET/CT scan) (time frame: 2 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Mar 2023.