Colorectal Cancer MetastaticONCOGRAMNCT03133273
Study of the Therapeutic Response and Survival of Patients with Metastatic Colorectal Cancer (stage IV) and Treated According to the Guidelines of a Chemosensitivity Test, Oncogramme® (ONCOGRAM)
A study testing Oncogramme® in people with Colorectal Cancer Metastatic and Chemotherapy, run by University Hospital, Limoges at 13 sites in France.
Trial summary
Currently, chemotherapies are empirically administered to patients treated for colorectal cancer (CRC). Selection is based on the efficacy of a protocol previously determined on the largest number (consensus treatment), the decision-making process being weighted by patient's intrinsic criteria. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Cancer Metastatic, Chemotherapy
- What is being tested?
- Oncogramme®
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 256 participants
- Where
- 13 sitesFrance
- Study dates
- 24 Jul 2017to 3 Apr 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
- Age ≥ 18 years
- Patient with metastatic colon or rectal adenocarcinoma (Stage IV) who can benefit from standard systemic chemotherapy (monotherapy based on 5-FU, polychemotherapy type FOLFOX, FOLFIRI, FOLFIRINOX, associated or not with targeted therapies Adapted to the expression of BRAF and RAS, whatever the route of administration of the proposed, oral or intravenous therapies)
- Metastatic CRC diagnosed preoperatively on imaging or per-operative on macroscopic findings and proved by histological analysis (biopsy or surgical excision and if possible biopsies or excrescence on the metastatic sites)
- Measurable metastases according to RECIST
- Chemotherapy for curative or palliative purposes
- Patient with consent.
- Affiliate or beneficiary of a social security scheme.
Who cannot join
- Formal contraindication to paraclinic exploration essential for patient follow-up
- Exclusive use of radiotherapy, targeted therapy, immunotherapy or hormone therapy, exclusive palliative support
- Patient with an absolute contraindication to the administration of chemotherapy
- Pregnant, lactating or non-contraceptive women for childbearing age women
- Patient with a difficulty of understanding the protocol
- Patient under protective measures (guardianship, curatorship, etc.).
Trial locations and contacts
13 sites in 1 country.
13 sites in 1 country
France13 sites
CHU d'AMIENS
Amiens, 80054
Bergonié Institut
Bordeaux, 33076
Clinique des Cédres
Brive-la-Gaillarde, 19100
CHU de TOURS
Chambray-lès-Tours, 37170
Clermont-Ferrand University Hospital
Clermont-Ferrand, 63003
CHu de la Martinique
Fort-De-France, 97261
Hospital Center
Guéret, 23000
Limoges University Hospital
Limoges, 87042
Nimes University Hospital
Nîmes, 30029
CHU de POITIERS
Poitiers, 86021
CH de Saint Junien
Saint-Junien, 87200
Centre Médical MGEN Alfred Leune
Sainte-Feyre, 23000
CHU de Strasbourg
Strasbourg, 67000
About this study
Official title: Study of the Therapeutic Response and Survival of Patients with Metastatic Colorectal Cancer (stage IV) and Treated According to the Guidelines of a Chemosensitivity Test, Oncogramme®
Currently, chemotherapies are empirically administered to patients treated for colorectal cancer (CRC). Selection is based on the efficacy of a protocol previously determined on the largest number (consensus treatment), the decision-making process being weighted by patient's intrinsic criteria. However, each patient is unique, due to the inter- and intratumoral heterogeneity inherent in any cancer, partly explaining the unsatisfactory response rates observed for available chemotherapies. Functional sensitivity tests offer the possibility to adapt the treatment to each patient: they are based on an ex vivo study of the responses of the tumor cells (survival / death) to the different molecules / therapeutic combinations (chemotherapy or targeted therapy) likely to be administered to the patient. This response, translated into a tumor-specific sensitivity profile, can be used by the clinicians to determine the most appropriate therapeutic protocol. By increasing the therapeutic efficacy from the first line and reducing the deleterious side effects associated with multiple drug cycles, the sensitivity test transforms the consensus approach into personalized medicine, providing patients with improved progression free survival (PFS) associated with an improvement in the quality of life. Oncomedics has developed Oncogramme®, a CE-labeled in vitro diagnostic medical device that has already demonstrated the ability to predict chemosensitivity in a recent pilot study of metastatic CRC (prediction with 84% chance of success of tumor sensitivity to chemotherapy, vs. 50% maximum for chemotherapy administered according to the consensus method). The hypothesis that patients treated with a metastatic CRC for which systemic chemotherapy is adapted using Oncogramme® have better response rates, PFS and quality of life than patients treated according to usual practice, with optimization of the costs of care. To our knowledge, this is the only fully standardized test available, where each step and reagents of the procedure are mastered. The reliability of the procedure makes it possible to render a personalized result for each patient in 97% of the cases. In addition, the analysis is specifically centered on tumor cells using a method using fully defined, developed and validated media and reagents for each cancer, including CRC. The method of revealing the effect of the therapies identifies the proportion of dead cells in each condition, whatever their physiological state (proliferation / quiescence), by determining the percentage of living and killed cells, thus ensuring high sensitivity
- Conditions
- Colorectal Cancer Metastatic, Chemotherapy
- Being tested
- Oncogramme®
- Keywords
- Colorectal Cancer Metastatic, Chemosensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oncogramme®Other
Patient is followed within the usual care for stage 4 colorectal cancer, but an Oncogramme test will be made and chemotherapy will be adapted to the results.
| Study group | Role | What they receive |
|---|---|---|
| Usual care | No intervention | Patient is followed within the usual care for stage 4 colorectal cancer |
| Oncogramme® | Experimental | For patients in the Oncogramme® group, chemotherapy will be adapted to Oncogramme® results. Receives: Other: Oncogramme® |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurrence of the progression or death of the patient.
The event studied is the occurrence of the progression or death of the patient during the year following the inclusion in the study. The progression of the patient is determined by the RECIST (Response Evaluation Criteria in Solid Tumors).
Measured: Year 1
Secondary outcomes (8)
Response to first-line treatment administrated
Percentage of patients in each response category to first-line treatment administered, evaluated by RECIST in each of the two groups.
Measured: every month, up to 12 months
Overall survival
The event study is the death of the patient during the 6 months and the year following the inclusion.
Measured: Month 6 and Year 1
Specific survival
The event considered is death due to illness during the 6 months and the year following the inclusion. The attribution of the death to the illness will be made by the adjudication committee.
Measured: Month 6 and Year 1
Incremental Cost / Efficiency Ratio
Calculation of the Incremental Cost / Efficiency Ratio (ICER) expressed in euros per year of life gained without occurrence of death or progression to 1 year of the adapted chemotherapeutic treatment according to the results of Oncogramme® using EQ5D-5L s
Measured: Year 1
Incremental Cost / Utility Ratio
Calculation of the Incremental Cost / Utility Ratio (ICUR) expressed in euros per QALY gained at 1 year of the adapted chemotherapeutic treatment according to the results of Oncogramme® using EQ5D-5L scale.
Measured: Year 1
Quality of life
Compare the quality of life of patients at 3 months, 6 months, 9 months and 1 year between the two groups using the EQ5D-5L questionary score.
Measured: Month 3, Month 6, Month 9 and Year 1
No adaptation of chemotherapy
If there is no adaptation of the treatment to the results of Oncogramme®, describe the criteria that led to the failure to take into account the results of Oncogramme®
Measured: every month, up to 12 months
Grade 3 and higher adverse events related to chemotherapy
Describe and compare in both groups the proportion of grade 3 and higher adverse events related to chemotherapy.
Measured: Year 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2017
- Study start24 Jul 2017
- Primary completion3 Apr 2024
- Study completion3 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Colorectal Cancer MetastaticStudies of the same condition, open and under way.
- More trials run by University Hospital, LimogesThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Patients corresponding to the inclusion criteria and having a histologically proven metastatic CRC on biopsies or primary tumor excision and / or one or more metastatic sites will be recruited prospectively and randomized into two groups. 1. Usual care group: no Oncogramme will be made. 2. Oncogramme group: Taking of tumor fragments on the histological piece by an anatomopathological physician at the time of the histological examination and placing samples in the transport medium. The Oncogramme will be performed by Oncomedics on all specimens. Results will be returned to clinicians within 15 days. For both groups, the adjuvant treatment will be decided in the multidisciplinary consultation meeting (MCM), according to the recommendations in force and adapted to the general medical condition of the patient. For patients in the Oncogramme group, chemotherapy will be adapted to Oncogramme.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 256 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Limoges
- Sponsor type
- University, hospital or other
- Collaborators
- Oncomédics
- Responsible party
- Sponsor
- Investigators
- Muriel Mathonnet, MD, Principal investigator, University Hospital, Limoges
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03133273
- Sponsor's protocol ID
- I16014 (ONCOGRAM)
- Acronym
- ONCOGRAM
- Status last verified
- Oct 2024
- First submitted
- 20 Apr 2017
- Last updated
- 18 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Mathonnet M, Vanderstraete M, Bounaix Morand du Puch C, Giraud S, Lautrette C, Ouaissi M, Tabchouri N, Taibi A, Martin R, Herafa I, Tchalla A, Christou N; ONCOGRAM trial investigators. ONCOGRAM: study protocol for the evaluation of therapeutic response and survival of metastatic colorectal cancer patients treated according to the guidelines of a chemosensitivity assay, the Oncogramme(R). Trials. 2021 Aug 21;22(1):556. doi: 10.1186/s13063-021-05531-y.
PubMed 34419125
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of the Therapeutic Response and Survival of Patients with Metastatic Colorectal Cancer (stage IV) and Treated According to the Guidelines of a Chemosensitivity Test, Oncogramme®
- ClinicalTrials.gov ID
- NCT03133273
- Acronym / sponsor ID
- ONCOGRAM / I16014 (ONCOGRAM)
- Conditions
- Colorectal Cancer Metastatic, Chemotherapy
- Keywords
- Colorectal Cancer Metastatic, Chemosensitivity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 256 participants (actual)
- Lead sponsor
- University Hospital, LimogesUniversity, hospital or other
- Collaborators
- Oncomédics
- Study start
- 24 Jul 2017 (actual)
- Primary completion
- 3 Apr 2024 (actual)
- Study completion
- 3 Apr 2024 (actual)
- First posted
- 28 Apr 2017 (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.
Currently, chemotherapies are empirically administered to patients treated for colorectal cancer (CRC). Selection is based on the efficacy of a protocol previously determined on the largest number (consensus treatment), the decision-making process being weighted by patient's intrinsic criteria. However, each patient is unique, due to the inter- and intratumoral heterogeneity inherent in any cancer, partly explaining the unsatisfactory response rates observed for available chemotherapies. Functional sensitivity tests offer the possibility to adapt the treatment to each patient: they are based on an ex vivo study of the responses of the tumor cells (survival / death) to the different molecules / therapeutic combinations (chemotherapy or targeted therapy) likely to be administered to the patient. This response, translated into a tumor-specific sensitivity profile, can be used by the clinicians to determine the most appropriate therapeutic protocol. By increasing the therapeutic efficacy from the first line and reducing the deleterious side effects associated with multiple drug cycles, the sensitivity test transforms the consensus approach into personalized medicine, providing patients with improved progression free survival (PFS) associated with an improvement in the quality of life. Oncomedics has developed Oncogramme®, a CE-labeled in vitro diagnostic medical device that has already demonstrated the ability to predict chemosensitivity in a recent pilot study of metastatic CRC (prediction with 84% chance of success of tumor sensitivity to chemotherapy, vs. 50% maximum for chemotherapy administered according to the consensus method). The hypothesis that patients treated with a metastatic CRC for which systemic chemotherapy is adapted using Oncogramme® have better response rates, PFS and quality of life than patients treated according to usual practice, with optimization of the costs of care. To our knowledge, this is the only fully standardized test available, where each step and reagents of the procedure are mastered. The reliability of the procedure makes it possible to render a personalized result for each patient in 97% of the cases. In addition, the analysis is specifically centered on tumor cells using a method using fully defined, developed and validated media and reagents for each cancer, including CRC. The method of revealing the effect of the therapies identifies the proportion of dead cells in each condition, whatever their physiological state (proliferation / quiescence), by determining the percentage of living and killed cells, thus ensuring high sensitivity
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Patients corresponding to the inclusion criteria and having a histologically proven metastatic CRC on biopsies or primary tumor excision and / or one or more metastatic sites will be recruited prospectively and randomized into two groups. 1. Usual care group: no Oncogramme will be made. 2. Oncogramme group: Taking of tumor fragments on the histological piece by an anatomopathological physician at the time of the histological examination and placing samples in the transport medium. The Oncogramme will be performed by Oncomedics on all specimens. Results will be returned to clinicians within 15 days. For both groups, the adjuvant treatment will be decided in the multidisciplinary consultation meeting (MCM), according to the recommendations in force and adapted to the general medical condition of the patient. For patients in the Oncogramme group, chemotherapy will be adapted to Oncogramme.
| Arm | Type | Receives |
|---|---|---|
| Usual care | No intervention | –Patient is followed within the usual care for stage 4 colorectal cancer |
| Oncogramme® | Experimental | Other: Oncogramme®For patients in the Oncogramme® group, chemotherapy will be adapted to Oncogramme® results. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age ≥ 18 years
- Patient with metastatic colon or rectal adenocarcinoma (Stage IV) who can benefit from standard systemic chemotherapy (monotherapy based on 5-FU, polychemotherapy type FOLFOX, FOLFIRI, FOLFIRINOX, associated or not with targeted therapies Adapted to the expression of BRAF and RAS, whatever the route of administration of the proposed, oral or intravenous therapies)
- Metastatic CRC diagnosed preoperatively on imaging or per-operative on macroscopic findings and proved by histological analysis (biopsy or surgical excision and if possible biopsies or excrescence on the metastatic sites)
- Measurable metastases according to RECIST
- Chemotherapy for curative or palliative purposes
Key exclusion criteria (6 listed)
- Formal contraindication to paraclinic exploration essential for patient follow-up
- Exclusive use of radiotherapy, targeted therapy, immunotherapy or hormone therapy, exclusive palliative support
- Patient with an absolute contraindication to the administration of chemotherapy
- Pregnant, lactating or non-contraceptive women for childbearing age women
- Patient with a difficulty of understanding the 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 |
|---|---|---|
| Oncogramme®Patient is followed within the usual care for stage 4 colorectal cancer, but an Oncogramme test will be made and chemotherapy will be adapted to the results. | Other | Oncogramme® |
Primary outcome
Occurrence of the progression or death of the patient.
Time frame: Year 1
The event studied is the occurrence of the progression or death of the patient during the year following the inclusion in the study. The progression of the patient is determined by the RECIST (Response Evaluation Criteria in Solid Tumors).
8 secondary outcomes
Response to first-line treatment administrated
Time frame: every month, up to 12 months
Overall survival
Time frame: Month 6 and Year 1
Specific survival
Time frame: Month 6 and Year 1
Incremental Cost / Efficiency Ratio
Time frame: Year 1
Incremental Cost / Utility Ratio
Time frame: Year 1
Quality of life
Time frame: Month 3, Month 6, Month 9 and Year 1
No adaptation of chemotherapy
Time frame: every month, up to 12 months
Grade 3 and higher adverse events related to chemotherapy
Time frame: Year 1
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 18 Oct 2024.
- Derived from this study: PubMed 34419125Mathonnet M, Vanderstraete M, Bounaix Morand du Puch C, Giraud S, Lautrette C, Ouaissi M, Tabchouri N, Taibi A, Martin R, Herafa I, Tchalla A, Christou N; ONCOGRAM trial investigators. ONCOGRAM: study protocol for the evaluation of therapeutic response and survival of metastatic colorectal cancer patients treated according to the guidelines of a chemosensitivity assay, the Oncogramme(R). Trials. 2021 Aug 21;22(1):556. doi: 10.1186/s13063-021-05531-y.
- Individual participant dataSharing planned: No
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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.
Muriel Mathonnet, MD principal investigator
University Hospital, Limoges
13 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Oncogramme® in people with Colorectal Cancer Metastatic and Chemotherapy, run by University Hospital, Limoges at 13 sites 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 7 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: finished, as of the sponsor's last update on 18 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites 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?
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?
Occurrence of the progression or death of the patient. (time frame: Year 1). 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 NCT03133273, which also lists 1 linked publication.
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 18 Oct 2024.