Metastatic Colorectal CancerTEP-PREDICTNCT05531045
18FFDG PET/CT for Early Evaluation of Chemotherapy Efficacy in Metastatic Colic Adenocarcinoma
An observational study of Metastatic Colorectal Cancer, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
The metastatic colo-rectal cancer (especially with hepatic metastatic lesions, but also peritoneal or pulmonary lesions) is a major public health issue, because of its frequency, the heavy treatments and the cost of new therapeutic molecules involved, in particular targeted therapies that can result in specific… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Colorectal Cancer
- What is being tested?
- PET/CT
- How many people
- 222 participants
- Where
- 1 siteFrance
- Study dates
- Sep 2022to Sep 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
Study population: Population fo patients with metastic colo-rectal cancer eligible to first line chemotherapy
Who may be able to join
- Histologically proved colo-rectal cancer
- Measurable metastatic disease according to RECIST 1.1 criteria
- Metastases considered potentially resectable (for example : hepatic, nodular peritoneal, lung lesions…) by the multidisciplinary committee meeting
- ECOG≤2
- Patient candidate to a first-line chemotherapy± targeted therapy according to standard protocols : LV5FU2, FOLFOX, FOLFIRI, FOLFIRINOX +/- bévacizumab, aflibercept , cétuximab, panitumumab
- In case of metachrone metastasis, adjuvant chemotherapy stopped for more than 6 months before relapse diagnosis
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- Predictable life expectancy of more than 6 months
- Signed informed consent
- Age > 18 years
Who cannot join
- Patient with another evolutive neoplastic disease
- Patient participating in another study evaluating an imaging technique using ionizing radiations
- Brain metastasis
- Absence of health insurance coverage
- Pregnant of breastfeeding woman
- Hypersensitivity to FDG or to one of the excipients of used specialty
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site
Hôpital Saint Louis
Paris, 75010
Thomas Aparico, MD, thomas.aparico@aphp.fr
About this study
Official title: 18F-FDG Positron Emission Tomography/Tomodensitometry for Early Evaluation of Chemotherapy Efficacy in Metastatic Colic Adenocarcinoma
The metastatic colo-rectal cancer (especially with hepatic metastatic lesions, but also peritoneal or pulmonary lesions) is a major public health issue, because of its frequency, the heavy treatments and the cost of new therapeutic molecules involved, in particular targeted therapies that can result in specific adverse events. The first-line treatment often consists of a polychemotherapy, which can be associated to a targeted therapy. According to the therapeutic response, patient condition and disease extent, some patients may benefit from prognosis-changing treatments such as surgery of metastases. However, the best morphological response is most of time evidenced after only 6 or 8 cycles of treatment, corresponding to 3 to 4 months. Therapeutic evaluation with FDG PET/CT is validated in several neoplasia (lymphoma, breast cancer). Data on FDG PET evaluation of colic cancer chemotherapy are currently insufficient to propose its use in the usual clinical setting. We thus are going to study the performance of early FDG PET therapeutic evaluation to predict response to first-line chemotherapy in patients with potentially resectable metastases. If early PET diagnostic performances prove satisfying, this approach could become of paramount importance to tailor therapeutic strategy for these patients, with the possibility of early modification of chemotherapy protocol, which is now possible thanks to the existence of therapeutic alternatives (chemotherapy intensification, replacement of oxaliptaine by irinotecan or conversely, replacement of an anti-EGFR by an anti-angiogenic or conversely).
- Conditions
- Metastatic Colorectal Cancer
- Being tested
- PET/CT
- 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/CTDiagnostic test
FDG PET/CT assessed after 2 cycles of chemotherapy with PERCIST criteria
| Study group | Role | What they receive |
|---|---|---|
| Cohort | FDG PET/CT assessed after 2 cycles of chemotherapy Receives: Diagnostic Test: PET/CT |
What is being measured
The primary outcome is the main question the study is designed to answer.
early metabolic response assessed by PERCIST criteria
Measured: 4 months
Secondary outcomes (9)
Resection of metastases defined by a R0 or R1 resection (macroscopically complete surgery with disease-free margins or minimal residual disease) after the end of first line chemotherapy
Measured: at the end of first line chemotherapy, an average of 12 months
Best morphological response during the course of first line chemotherapy
Measured: at the end of first line chemotherapy, an average of 12 months
percentage of cases where early metabolic response evaluation would have led to a modification of the therapeutic strategy/management
Measured: Month 2
Progression Free Survival
Measured: 36 months
Overall Survival
Measured: 36 months
ΔSUVmax (EORTC criteria) between Pre-therapeutic and 2 cycles PET assessment
Measured: 2 months
ΔSULpeak (PERCIST criteria) between Pre-therapeutic and 2 cycles PET assessment
Measured: 2 months
ΔMTV between Pre-therapeutic and 2 cycles PET assessment
Measured: 2 months
ΔTLG between Pre-therapeutic and 2 cycles PET assessment
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2022
- Study startSep 2022 (estimated)
- Primary completionJan 2025 (estimated)
- Study completionSep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Colorectal CancerStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 222 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Thomas Aparicio, MD, Study director, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05531045
- Sponsor's protocol ID
- APHP180576
- Acronym
- TEP-PREDICT
- Status last verified
- Aug 2022
- First submitted
- 11 Aug 2022
- Last updated
- 7 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 7 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 18F-FDG Positron Emission Tomography/Tomodensitometry for Early Evaluation of Chemotherapy Efficacy in Metastatic Colic Adenocarcinoma
- ClinicalTrials.gov ID
- NCT05531045
- Acronym / sponsor ID
- TEP-PREDICT / APHP180576
- Conditions
- Metastatic Colorectal Cancer
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 222 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- Sep 2022 (estimated)
- Primary completion
- Jan 2025 (estimated)
- Study completion
- Sep 2027 (estimated)
- First posted
- 7 Sep 2022 (actual)
- 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 metastatic colo-rectal cancer (especially with hepatic metastatic lesions, but also peritoneal or pulmonary lesions) is a major public health issue, because of its frequency, the heavy treatments and the cost of new therapeutic molecules involved, in particular targeted therapies that can result in specific adverse events. The first-line treatment often consists of a polychemotherapy, which can be associated to a targeted therapy. According to the therapeutic response, patient condition and disease extent, some patients may benefit from prognosis-changing treatments such as surgery of metastases. However, the best morphological response is most of time evidenced after only 6 or 8 cycles of treatment, corresponding to 3 to 4 months. Therapeutic evaluation with FDG PET/CT is validated in several neoplasia (lymphoma, breast cancer). Data on FDG PET evaluation of colic cancer chemotherapy are currently insufficient to propose its use in the usual clinical setting. We thus are going to study the performance of early FDG PET therapeutic evaluation to predict response to first-line chemotherapy in patients with potentially resectable metastases. If early PET diagnostic performances prove satisfying, this approach could become of paramount importance to tailor therapeutic strategy for these patients, with the possibility of early modification of chemotherapy protocol, which is now possible thanks to the existence of therapeutic alternatives (chemotherapy intensification, replacement of oxaliptaine by irinotecan or conversely, replacement of an anti-EGFR by an anti-angiogenic or conversely).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cohort | – | Diagnostic Test: PET/CTFDG PET/CT assessed after 2 cycles of chemotherapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Population fo patients with metastic colo-rectal cancer eligible to first line chemotherapy
Key inclusion criteria (9 listed)
- Histologically proved colo-rectal cancer
- Measurable metastatic disease according to RECIST 1.1 criteria
- Metastases considered potentially resectable (for example : hepatic, nodular peritoneal, lung lesions…) by the multidisciplinary committee meeting
- ECOG≤2
- Patient candidate to a first-line chemotherapy± targeted therapy according to standard protocols : LV5FU2, FOLFOX, FOLFIRI, FOLFIRINOX +/- bévacizumab, aflibercept , cétuximab, panitumumab
Key exclusion criteria (6 listed)
- Patient with another evolutive neoplastic disease
- Patient participating in another study evaluating an imaging technique using ionizing radiations
- Brain metastasis
- Absence of health insurance coverage
- Pregnant of breastfeeding woman
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/CTFDG PET/CT assessed after 2 cycles of chemotherapy with PERCIST criteria | Diagnostic test | Cohort |
Primary outcome
early metabolic response assessed by PERCIST criteria
Time frame: 4 months
9 secondary outcomes
Resection of metastases defined by a R0 or R1 resection (macroscopically complete surgery with disease-free margins or minimal residual disease) after the end of first line chemotherapy
Time frame: at the end of first line chemotherapy, an average of 12 months
Best morphological response during the course of first line chemotherapy
Time frame: at the end of first line chemotherapy, an average of 12 months
percentage of cases where early metabolic response evaluation would have led to a modification of the therapeutic strategy/management
Time frame: Month 2
Progression Free Survival
Time frame: 36 months
Overall Survival
Time frame: 36 months
ΔSUVmax (EORTC criteria) between Pre-therapeutic and 2 cycles PET assessment
Time frame: 2 months
ΔSULpeak (PERCIST criteria) between Pre-therapeutic and 2 cycles PET assessment
Time frame: 2 months
ΔMTV between Pre-therapeutic and 2 cycles PET assessment
Time frame: 2 months
ΔTLG between Pre-therapeutic and 2 cycles PET assessment
Time frame: 2 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Sep 2022.
- Individual participant dataSharing planned: Undecided
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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.
Thomas Aparicio, MD study director
Assistance Publique - Hôpitaux de Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Metastatic Colorectal Cancer, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
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 9 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: opening soon, as of the sponsor's last update on 7 Sep 2022. 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 France. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Laetitia Vercellino, MD (+33142499411, laetitia.vercellino@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
early metabolic response assessed by PERCIST criteria (time frame: 4 months). 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 7 Sep 2022.