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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) (ONCOGRAM)

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ClinicalTrials.gov Identifier: NCT03133273
Recruitment Status : Recruiting
First Posted : April 28, 2017
Last Update Posted : September 6, 2019
Sponsor:
Collaborator:
Oncomédics
Information provided by (Responsible Party):
University Hospital, Limoges

Brief 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. 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

Condition or disease Intervention/treatment Phase
Colorectal Cancer Metastatic Chemotherapy Other: Oncogramme® Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 256 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention 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 (Participant)
Masking Description: The result of Oncogramme® will not give to the patient.
Primary Purpose: Other
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®
Actual Study Start Date : July 24, 2017
Estimated Primary Completion Date : July 24, 2022
Estimated Study Completion Date : July 24, 2022

Arm Intervention/treatment
No Intervention: Usual care
Patient is followed within the usual care for stage 4 colorectal cancer
Experimental: Oncogramme®
For patients in the Oncogramme® group, chemotherapy will be adapted to Oncogramme® results.
Other: 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.




Primary Outcome Measures :
  1. 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).


Secondary Outcome Measures :
  1. Response to first-line treatment administrated [ Time Frame: every month, up to 12 months ]
    Percentage of patients in each response category to first-line treatment administered, evaluated by RECIST in each of the two groups.

  2. Overall survival [ Time Frame: Month 6 and Year 1 ]
    The event study is the death of the patient during the 6 months and the year following the inclusion.

  3. Specific survival [ Time Frame: Month 6 and Year 1 ]
    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.

  4. Incremental Cost / Efficiency Ratio [ Time Frame: Year 1 ]
    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

  5. Incremental Cost / Utility Ratio [ Time Frame: Year 1 ]
    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.

  6. Quality of life [ Time Frame: Month 3, Month 6, Month 9 and Year 1 ]
    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.

  7. No adaptation of chemotherapy [ Time Frame: every month, up to 12 months ]
    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®

  8. Grade 3 and higher adverse events related to chemotherapy [ Time Frame: Year 1 ]
    Describe and compare in both groups the proportion of grade 3 and higher adverse events related to chemotherapy.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03133273


Contacts
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Contact: Muriel Mathonnet, MD +33555056701 muriel.mathonnet@unilim.fr
Contact: Isabelle Herafa +33555058606 isabelle.herafa@chu-limoges.fr

Locations
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France
CHU d'AMIENS Recruiting
Amiens, France, 80054
Contact: jean-Marc REGIMBEAU, MD         
Principal Investigator: jean-Marc REGIMBEAU, MD         
Bergonié Institut Terminated
Bordeaux, France, 33076
CH de BRIVE Withdrawn
Brive-la-Gaillarde, France, 19100
Clinique des Cédres Terminated
Brive-la-Gaillarde, France, 19100
CHU de TOURS Recruiting
Chambray-lès-Tours, France, 37170
Contact: Medhi OUAISSI, MD    247478614 ext +33    m.ouaissi@chu-tours.fr   
Principal Investigator: Medhi OUAISSI, MD         
Clermont-Ferrand University Hospital Recruiting
Clermont-Ferrand, France, 63003
Contact: Denis Pezet, MD    +33473750494    dpezet@chu-clermontferrand.fr   
Principal Investigator: Denis PEZET, MD         
Sub-Investigator: Anne DUBOIS, MD         
Sub-Investigator: Caroline PEROTIN, MD         
Sub-Investigator: Olivier ANTOMARCHI, MD         
Sub-Investigator: Adnan ABOUKASSEM, MD         
Sub-Investigator: Agnes VIMAL-BAGUET, MD         
Hospital Center Recruiting
Guéret, France, 23000
Contact: Li CHEN, MD    555517041 ext +33    l.chen@chgueret.fr   
Principal Investigator: Li CHEN, MD         
Sub-Investigator: Zekeriaou AMADOU, MD         
Sub-Investigator: Christos CHRISTOPOULOS, MD         
Sub-Investigator: GHASSAN NAKHAL, MD         
Limoges University Hospital Recruiting
Limoges, France, 87042
Contact: Muriel MATHONNET, MD    +33555056701    muriel.mathonnet@unilim.fr   
Contact: isabelle Herafa, MD    +33555058606    isabelle.herafa@chu-limoges.fr   
Principal Investigator: Muriel MATHONNET, MD         
Sub-Investigator: Stéphane BOUVIER, MD         
Sub-Investigator: Niki CHRISTOU, MD         
Sub-Investigator: Anne FABRE, MD         
Sub-Investigator: Abdelkader TAIBI, MD         
Sub-Investigator: Denis VALLEIX, MD         
Sub-Investigator: Paul CARRIER, MD         
Sub-Investigator: Roger DALOKO LONFO, MD         
Sub-Investigator: Etienne CHUFFART, MD         
Sub-Investigator: Sylviane DURAND-FONTANIER, MD         
Sub-Investigator: Sophiane DERBAL, MD         
Sub-Investigator: Frédéric THUILLIER, MD         
Sub-Investigator: Thibault RIVAILLE, MD         
Sub-Investigator: Valérie LEBRUN-LY, MD         
Sub-Investigator: Sandrine LAVAU-DENES, MD         
Sub-Investigator: Romain LEGROS, MD         
Nimes University Hospital Terminated
Nîmes, France, 30029
CHU de POITIERS Recruiting
Poitiers, France, 86021
Contact: David TOUGERON, MD    549443751 ext +33    david.tougeron@chu-poitiers.fr   
Principal Investigator: David TOUGERON, MD         
CH de Saint Junien Recruiting
Saint-Junien, France, 87200
Contact: Frédéric THUILLIER, MD       frederic.thuillier@chu-limoges.fr   
Principal Investigator: Frédéric THUILLIER, MD         
Sub-Investigator: Thibault RIVAILLE, MD         
Sub-Investigator: Sophiane DERBAL, MD         
Centre Médical MGEN Alfred Leune Active, not recruiting
Sainte-Feyre, France, 23000
Sponsors and Collaborators
University Hospital, Limoges
Oncomédics
Investigators
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Principal Investigator: Muriel Mathonnet, MD University Hospital, Limoges

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Responsible Party: University Hospital, Limoges
ClinicalTrials.gov Identifier: NCT03133273    
Other Study ID Numbers: I16014 (ONCOGRAM)
First Posted: April 28, 2017    Key Record Dates
Last Update Posted: September 6, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Hospital, Limoges:
Colorectal Cancer Metastatic
Chemosensitivity
Additional relevant MeSH terms:
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Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases