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A national, multicenter, open-label, randomized phase III study. The trial aim is to determine the best therapeutic strategies according with the HRQoL.
Treatment cohort will be determined based on three parameters:
The "Candidate" group will be defined according to (all the following criteria must be fulfilled):
The "Non-candidate" cohort group will be defined according to (at least one of those parameters is fulfilled):
Patients in the "Candidate group" will be randomized to:
Patients in the "Non-candidate" group cohort
- Not randomized, follow-up patients receiving: capecitabine + bevacizumab
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| "Candidate group" OPTIMOX plus bevacizumab (Arm A) | Active Comparator | Patients with :
Adapted FOLFOX7 (aFOLFOX7)-bevacizumab for 6 cycles and then Adapted LV5FU2 (aLV5FU2)-bevacizumab (until progression or or unacceptable limiting toxicity) |
|
| "Candidate group" - Capecitabine-bevacizumab (Arm B) | Active Comparator | Patients with :
This treatment regimen will be given until disease progression (PD) or unacceptable limiting toxicity, as follows: |
|
| "Non candidate group" - Capecitabine-bevacizumab | Active Comparator | Patients with:
This treatment regimen will be given until disease progression (PD) or unacceptable limiting toxicity, as follows: |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| OPTIMOX-bevacizumab | Drug | Induction Adapted FOLFOX7 (aFOLFOX7)-bevacizumab for 6 cycles (3 months)
then Maintenance Adapted LV5FU2 (aLV5FU2)-bevacizumab (until progression or or unacceptable limiting toxicity)
|
| Measure | Description | Time Frame |
|---|---|---|
| Health-related quality of life (HRQoL) at 6 months in the "candidate group". | Improvement of HRQoL at 6 months by 10 points compared to the score at inclusion on the following targeted dimensions: emotional functioning (4 items) and global health (2 items) (score from 6-30 with higher values representing better quality of life). | At 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Number of patients amenable to second-line therapy. | Proportion of patients amenable to second-line therapy. | until 58 months |
| Number of patient amenable to surgery and/or locoregional therapy. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Elisabeth CAROLA, MD | UCOG Picardie Groupe Hospitalier Public du Sud de l'Oise (GHPSO) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CH Abbeville | Abbeville | France | ||||
| CHU Amiens Hôpital sud |
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|
|
| Capecitabine plus bevacizumab | Drug |
|
|
|
Proportion of patients amenable to salvage surgery and/or locoregional therapy (e.g., radiofrequency ablation, stereotactic radiotherapy, …).
| until 58 months |
| Progression-free survival (PFS) | PFS is defined as time from date of first dose of study treatment to date of first documented PD or death due to any cause determined by the Investigator assessment in accordance to RECIST 1.1. Alive patients without progression will be censored at the last tumor assessment, either during study treatment period or during follow-up period. | until 58 months |
| Overall survival (OS) | OS defined as the time between the date of the first dose of study treatment and the death date. Alive patients will be censored at the last date known to be alive, either during study treatment period or during follow-up period. | Until 58 months |
| Other dimensions of health-related quality of life (HRQoL) and longitudinal HRQoL | HRQoL: all other dimensions of the QLQC-30 and QLQELD-14 questionnaires, and longitudinal analyses of the QLQC-30 and QLQELD-14 elderly specific module integrating all measurement times. | Until 58 months |
| Determination of instrumental activities of daily living (IADL) as prognostic factor for overall survival (OS). | IADL as prognostic factor for overall survival (OS) and treatment toxicity. | Until 58 months |
| G8 score at baseline. | To determine G8 score at baseline and to correlate the candidate group and the non-candidate group according to G8 score. | until 58 months |
| Performance status geriatric (PSG) score. | External analysis of PSG score as predictive for treatment efficacy: PFS and OS. | until 58 months |
| Amiens |
| France |
| Clinique de l'Europe | Amiens | France |
| CH Beauvais | Beauvais | France |
| Hôpital Duchenne | Boulogne-sur-Mer | France |
| Centre hospitalier de Cannes | Cannes | France |
| CH Compiègne Noyon | Compiègne | France |
| UCOG Picardie Groupe Hospitalier | Creil | France |
| CHU Henri Mondor | Créteil | France |
| Centre geroges François Leclerc | Dijon | France |
| Institut Daniel Hollard | Grenoble | France |
| Institut Hospitalier Franco-Britannique | Levallois-Perret | France |
| Hôpital Privé Jean Mermoz | Lyon | France |
| Institut Paoli-Calmettes | Marseille | France |
| CH Sud Ile de France | Melun | France |
| CH Mont de Marsan | Mont-de-Marsan | France |
| Centre Antoine Lacassagne | Nice | France |
| Hôpital des Diaconnesses Croix Saint Simon | Paris | France |
| Hôpital Saint Antoine | Paris | France |
| Institut Mutualiste Montsouris | Paris | France |
| CH Annecy Genevois | Pringy | France |
| CH Saint Malo | St-Malo | France |
| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
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| ID | Term |
|---|---|
| D002955 | Leucovorin |
| D000068258 | Bevacizumab |
| D000069287 | Capecitabine |
| ID | Term |
|---|---|
| D005575 | Formyltetrahydrofolates |
| D013763 | Tetrahydrofolates |
| D005492 | Folic Acid |
| D011622 | Pterins |
| D011621 | Pteridines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D003067 | Coenzymes |
| D045762 | Enzymes and Coenzymes |
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D005472 | Fluorouracil |
| D014498 | Uracil |
| D011744 | Pyrimidinones |
| D003853 | Deoxyribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
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