Metastatic Colorectal CancerCD3-OncoQuantNCT02364024
Validation Study of Linear Quantification of CD3+ Cells in Localized Colorectal Carcinomas
An observational study of Metastatic Colorectal Cancer, run by Federation Francophone de Cancerologie Digestive.
Trial summary
The purpose of this study is to confirm that linear quantification of CD3+ cells is a prognostic biomarker in localized colorectal carcinomas. Read more about this study
- Who is it for?
- Ages 18 to 74 years
- Conditions the study is for
- Metastatic Colorectal Cancer
- How many people
- 856 participants
- Where
- No sites listed yet
- Study dates
- Nov 2005to Apr 2017
- Phase
- Observational
- 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 to 74 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patient of both gender who have underwent surgical resection of stage III colorectal carcinoma
Who may be able to join
- Patient included in PETACC08 study
- Signed informed consent for translational study
- FFPE tumor sample available for CD3 staining
Who cannot join
- Patient who have withdrawn their consent for PETACC08 and/or for PETACC08 translational study
About this study
Official title: Biomarker Validation Study of Linear Quantification of CD3 Positive Cells in Localized Colorectal Carcinomas, Based on the Cohort of Patient Included in PETACC8 International Phase III Trial (NCT00265811)
The purpose of this study is to confirm that linear quantification of CD3+ cells is a prognostic biomarker in localized colorectal carcinomas.
Read the detailed description
Adult patients of both gender who have underwent surgical resection of stage III colorectal carcinoma and randomised to receive a chemotherapy FOLFOX or FOLFOX + Cetuximab in the PETACC8 trial.
- Conditions
- Metastatic Colorectal Cancer
- Keywords
- Colon and rectum carcinoma, Immune response, Biomarker, Prognosis
- Medical subject headings
- Colorectal Neoplasms, Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Arm A | Patients with no or low immune response (score 1 or 2) with linear quantification of CD3+ cells | |
| Arm B | Patients with high immune response (score 3 or 4) with linear quantification of CD3+ cells |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to Recurrence (TTR)
TTR is defined by the time between randomisation and the first event occured (Local or metastatic recurrence or death due to disease recurrence) whichever occured first or last follow-up ( Last news for patients without event (censored data))
Measured: 2 years
Secondary outcomes (2)
Overall Survival (OS)
Overall survival is defined as the time from randomization to death any cause or last follow-up news (censored data).
Measured: until death
Disease-Free Survival (DFS)
DFS is defined by the time between randomisation and the first event occured (Local or metastatic recurrence or second cancer or death (all causes)) whichever occured first or last follow-up ( Last news for patients without event (censored data))
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Feb 2015 (estimated)
- Study startNov 2005
- Primary completionMay 2009
- Study completionApr 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Metastatic Colorectal CancerStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 856 participants (actual)
Sponsor and investigators
- Lead sponsor
- Federation Francophone de Cancerologie Digestive
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Emile Jean-François, Pr, Study director, Fédération Fancophone de Cancérologie Digestive
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02364024
- Sponsor's protocol ID
- PETACC8-BIO1
- Acronym
- CD3-OncoQuant
- Status last verified
- Jul 2018
- First submitted
- 10 Feb 2015
- Last updated
- 6 Jul 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
Taieb J, Tabernero J, Mini E, Subtil F, Folprecht G, Van Laethem JL, Thaler J, Bridgewater J, Petersen LN, Blons H, Collette L, Van Cutsem E, Rougier P, Salazar R, Bedenne L, Emile JF, Laurent-Puig P, Lepage C; PETACC-8 Study Investigators. Oxaliplatin, fluorouracil, and leucovorin with or without cetuximab in patients with resected stage III colon cancer (PETACC-8): an open-label, randomised phase 3 trial. Lancet Oncol. 2014 Jul;15(8):862-73. doi: 10.1016/S1470-2045(14)70227-X. Epub 2014 Jun 11.
PubMed 24928083Emile JF, Julie C, Le Malicot K, Lepage C, Tabernero J, Mini E, Folprecht G, Van Laethem JL, Dimet S, Boulagnon-Rombi C, Allard MA, Penault-Llorca F, Bennouna J, Laurent-Puig P, Taieb J; PETACC8 Study Investigators; Austrian Breast and Colorectal cancer Study Group (ABCSG); Belgian Group of Digestive Oncology (BGDO); Lone Norgard Petersen; Federation Francophone de Cancerologie Digestive (FFCD); Federation Nationale des Centres de Lutte Contre le Cancer (UNICANCER); Federation Nationale des Centres de Lutte Contre le Cancer Association Europeenne de Recherche en Oncologie (AERO); Arbeitsgemeinschaft Internistische Onkologie (AIO); Gruppo Italiano per lo Studio dei Carcinomi dell'Apparato Digerente (GISCAD); Gruppo Oncologico dell'Italia Meridionale (GOIM); Istituto Oncologico Romagnolo (IOR); Gruppo Cooperativo Chirurgico Italiano (GOCCI); Gruppo Oncologico Nord Ovest (GONO); Gruppo Oncologico Italiano di Ricerca Clinica (GOIRC); Gruppo Cooperativo do Cancro Digestivo da Associacao Portuguesa de Investigacao Oncologica (GCCD, APIO); Grupo Espanol para el Tratamiento de los Tumores Digestivos (TTD); John Allen Bridgewater. Prospective validation of a lymphocyte infiltration prognostic test in stage III colon cancer patients treated with adjuvant FOLFOX. Eur J Cancer. 2017 Sep;82:16-24. doi: 10.1016/j.ejca.2017.04.025. Epub 2017 Jun 23.
PubMed 28651158
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Biomarker Validation Study of Linear Quantification of CD3 Positive Cells in Localized Colorectal Carcinomas, Based on the Cohort of Patient Included in PETACC8 International Phase III Trial (NCT00265811)
- ClinicalTrials.gov ID
- NCT02364024
- Acronym / sponsor ID
- CD3-OncoQuant / PETACC8-BIO1
- Conditions
- Metastatic Colorectal Cancer
- Keywords
- Colon and rectum carcinoma, Immune response, Biomarker, Prognosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 856 participants (actual)
- Lead sponsor
- Federation Francophone de Cancerologie DigestiveUniversity, hospital or other
- Study start
- Nov 2005
- Primary completion
- May 2009 (actual)
- Study completion
- Apr 2017 (actual)
- First posted
- 16 Feb 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 confirm that linear quantification of CD3+ cells is a prognostic biomarker in localized colorectal carcinomas.
Detailed description
Adult patients of both gender who have underwent surgical resection of stage III colorectal carcinoma and randomised to receive a chemotherapy FOLFOX or FOLFOX + Cetuximab in the PETACC8 trial.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm A | – | –Patients with no or low immune response (score 1 or 2) with linear quantification of CD3+ cells |
| Arm B | – | –Patients with high immune response (score 3 or 4) with linear quantification of CD3+ cells |
Who may qualify
- Ages
- 18 to 74 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patient of both gender who have underwent surgical resection of stage III colorectal carcinoma
Key inclusion criteria (3 listed)
- Patient included in PETACC08 study
- Signed informed consent for translational study
- FFPE tumor sample available for CD3 staining
Key exclusion criteria (1 listed)
- Patient who have withdrawn their consent for PETACC08 and/or for PETACC08 translational study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Time to Recurrence (TTR)
Time frame: 2 years
TTR is defined by the time between randomisation and the first event occured (Local or metastatic recurrence or death due to disease recurrence) whichever occured first or last follow-up ( Last news for patients without event (censored data))
2 secondary outcomes
Overall Survival (OS)
Time frame: until death
Disease-Free Survival (DFS)
Time frame: 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jul 2018.
- Background: PubMed 24928083Taieb J, Tabernero J, Mini E, Subtil F, Folprecht G, Van Laethem JL, Thaler J, Bridgewater J, Petersen LN, Blons H, Collette L, Van Cutsem E, Rougier P, Salazar R, Bedenne L, Emile JF, Laurent-Puig P, Lepage C; PETACC-8 Study Investigators. Oxaliplatin, fluorouracil, and leucovorin with or without cetuximab in patients with resected stage III colon cancer (PETACC-8): an open-label, randomised phase 3 trial. Lancet Oncol. 2014 Jul;15(8):862-73. doi: 10.1016/S1470-2045(14)70227-X. Epub 2014 Jun 11.
- Results publication: PubMed 28651158Emile JF, Julie C, Le Malicot K, Lepage C, Tabernero J, Mini E, Folprecht G, Van Laethem JL, Dimet S, Boulagnon-Rombi C, Allard MA, Penault-Llorca F, Bennouna J, Laurent-Puig P, Taieb J; PETACC8 Study Investigators; Austrian Breast and Colorectal cancer Study Group (ABCSG); Belgian Group of Digestive Oncology (BGDO); Lone Norgard Petersen; Federation Francophone de Cancerologie Digestive (FFCD); Federation Nationale des Centres de Lutte Contre le Cancer (UNICANCER); Federation Nationale des Centres de Lutte Contre le Cancer Association Europeenne de Recherche en Oncologie (AERO); Arbeitsgemeinschaft Internistische Onkologie (AIO); Gruppo Italiano per lo Studio dei Carcinomi dell'Apparato Digerente (GISCAD); Gruppo Oncologico dell'Italia Meridionale (GOIM); Istituto Oncologico Romagnolo (IOR); Gruppo Cooperativo Chirurgico Italiano (GOCCI); Gruppo Oncologico Nord Ovest (GONO); Gruppo Oncologico Italiano di Ricerca Clinica (GOIRC); Gruppo Cooperativo do Cancro Digestivo da Associacao Portuguesa de Investigacao Oncologica (GCCD, APIO); Grupo Espanol para el Tratamiento de los Tumores Digestivos (TTD); John Allen Bridgewater. Prospective validation of a lymphocyte infiltration prognostic test in stage III colon cancer patients treated with adjuvant FOLFOX. Eur J Cancer. 2017 Sep;82:16-24. doi: 10.1016/j.ejca.2017.04.025. Epub 2017 Jun 23.
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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.
Emile Jean-François, Pr study director
Fédération Fancophone de Cancérologie Digestive
Questions about this trial
What is this clinical trial studying?
An observational study of Metastatic Colorectal Cancer, run by Federation Francophone de Cancerologie Digestive.
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 3 inclusion and 1 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: finished, as of the sponsor's last update on 6 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Time to Recurrence (TTR) (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02364024, which also lists 2 linked publications.
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 6 Jul 2018; AzTrials last refreshed its copy on 2 Nov 2026.