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 : March 11, 2021
|Condition or disease||Intervention/treatment||Phase|
|Colorectal Cancer Metastatic Chemotherapy||Other: Oncogramme®||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||256 participants|
|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.
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 Description:||The result of Oncogramme® will not give to the patient.|
|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|
No Intervention: Usual care
Patient is followed within the usual care for stage 4 colorectal cancer
For patients in the Oncogramme® group, chemotherapy will be adapted to Oncogramme® results.
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.
- 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).
- 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.
- 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.
- 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.
- 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
- 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.
- 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.
- 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®
- 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.
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
|Contact: Muriel Mathonnet, MDemail@example.com|
|Contact: Isabelle Herafafirstname.lastname@example.org|
|Amiens, France, 80054|
|Contact: jean-Marc REGIMBEAU, MD|
|Principal Investigator: jean-Marc REGIMBEAU, MD|
|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 email@example.com|
|Principal Investigator: Medhi OUAISSI, MD|
|Clermont-Ferrand University Hospital||Recruiting|
|Clermont-Ferrand, France, 63003|
|Contact: Denis Pezet, MD +33473750494 firstname.lastname@example.org|
|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|
|CHu de la Martinique||Recruiting|
|Fort-De-France, France, 97261|
|Contact: Emmanuel RIVKINE, MD email@example.com|
|Principal Investigator: Emmanuel RIVKINE, MD|
|Guéret, France, 23000|
|Contact: Li CHEN, MD 555517041 ext +33 firstname.lastname@example.org|
|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 email@example.com|
|Contact: isabelle Herafa, MD +33555058606 firstname.lastname@example.org|
|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||Terminated|
|Poitiers, France, 86021|
|CH de Saint Junien||Terminated|
|Saint-Junien, France, 87200|
|Centre Médical MGEN Alfred Leune||Active, not recruiting|
|Sainte-Feyre, France, 23000|
|Principal Investigator:||Muriel Mathonnet, MD||University Hospital, Limoges|