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| Name | Class |
|---|---|
| Eli Lilly and Company | INDUSTRY |
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The primary objective is to evaluate six months survival rate and quality of life at 4 months of ramucirumab alone or in combination with paclitaxel in patients aged 70 years or more who have stomach or GEJ adenocarcinoma and whose first line of fluoropyrimidine- and platinumcontaining treatment has failed.
The co-primary endpoints are the following:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ramucirumab | Experimental | IV ramucirumab at 8 mg/kg on D1 and D15 |
|
| Ramucirumab + Paclitaxel | Active Comparator | IV ramucirumab at 8 mg/kg on D1 and D15 IV paclitaxel at 80 mg/m² on D1, D8 and D15 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ramucirumab | Drug | IV ramucirumab at 8 mg/kg on D1 and D15 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Patient survival rate at 6 months | Rate of patients alive | at 6 months |
| Quality of life at 4 months as assessed by the following dimension of the EORTC QLQ-ELD14 questionnaire: mobility | Derived from items 31,33 and 34of the ELD14 questionnaire. The score is from 0 to 100. The endpoint is defined as the difference of at least 10 points (clinical significance) between baseline score and 4-months score. | at 4 months |
| Quality of life at 4 months as assessed by the following dimension of the EORTC QLQ-ELD14 questionnaire: worries about the future | Derived from items 31,33 and 34of the ELD14 questionnaire. The score is from 0 to 100. The endpoint is defined as the difference of at least 10 points (clinical significance) between baseline score and 4-months score. | at 4 months |
| Quality of life at 4 months as assessed by the following dimension of the EORTC QLQ-ELD14 questionnaire: illness burden | Derived from items 43 and 44of the ELD14 questionnaire. The score is from 0 to 100. The endpoint is defined as the difference of at least 10 points (clinical significance) between baseline score and 4-months score | at 4 months |
| Measure | Description | Time Frame |
|---|---|---|
| Overall survival | Defined as time to death (whatever cause is) or for patients alive time to last news. | 6 months |
| Time to treatment failure | Time between randomization and disease progression, treatment interruption or death |
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Inclusion Criteria:
Histologically confirmed, unresectable, locally advanced or metastatic gastric or gastroesophageal junction (GEJ) adenocarcinoma, whatever HER2 status
Aged ≥ 70 years
WHO < 2
Estimated life expectancy > 3 months
Measurable or non-measurable disease according to RECIST 1.1 criteria
Documented progression during first-line fluoropyrimidine- and platinum- or irinotecan containing chemotherapy (with or without anthracycline), or during the 4 months following the last cycle of such chemotherapy administered for metastatic or locally advanced disease, or during the 6 months following the last dose of adjuvant therapy containing fluoropyrimidine and platinium (treatment by immunotherapy is allowed)
Adequate hepatic, renal and hematologic function:
EORTC QLQ-C30 + QLQ-ELD14, completed and faxed to the Randomization, Management and Analysis Center of the FFCD
IADL geriatric questionnaire, completed and faxed to Randomization Management and Analysis Center of FFCD
Signed informed consent
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Astrid Lièvre, Pr | CHU de Pontchaillou - Rennes | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CH - | Abbeville | France | ||||
| CH - Albi |
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| Paclitaxel | Drug | IV paclitaxel at 80 mg/m² on D1, D8 and D15 |
|
|
| 6 months |
| Progression-free survival | Progression-free survival (clinical and/or radiological) determined by the investigator based on RECIST V1.1 | 6 months |
| Albi |
| France |
| PRIVEE - L'Europe | Amiens | France |
| CAC - ICO Site Paul Papin | Angers | France |
| Privee - Hopital Prive | Antony | France |
| Ch - Victor Dupouy | Argenteuil | France |
| Ch - Metz Thionville Mercy | Ars-Laquenexy | France |
| Ch - Ght Unyon Auxerre | Auxerre | France |
| Privee - Institut Du Cancer Avignon Provence | Avignon | France |
| Ch - Cote Basque | Bayonne | France |
| Ch - Beauvais Ch | Beauvais | France |
| Chu - Jean Minjoz | Besançon | France |
| Privee - Tivoli | Bordeaux | France |
| PRIVEE - Polyclinique Saint Privat | Boujan-sur-Libron | France |
| Ch - Duchenne | Boulogne-sur-Mer | France |
| Ch - Pierre Oudot | Bourgoin | France |
| Privee - Pasteur Lanroze | Brest | France |
| Cac - François Baclesse | Caen | France |
| Chu - Côte de Nacre | Caen | France |
| Ch - Jean Rougier | Cahors | France |
| Privee - Infirmerie Protestante | Caluire-et-Cuire | France |
| CH - | Carcassonne | France |
| Ch - Castres Mazamet Chi | Castres | France |
| Prive - Médipole de Savoie | Challes-les-Eaux | France |
| Prive - Sainte Marie | Chalon-sur-Saône | France |
| CH - | Cholet | France |
| Ch - Hopitaux Civils de Colmar | Colmar | France |
| Hopitaux civils de Colmar | Colmar | France |
| Chu - Louis Mourier | Colombes | France |
| Prive - Saint Côme | Compiègne | France |
| Prive - Cédres | Cornebarrieu | France |
| Chu - Henri Mondor | Créteil | France |
| Prive - Centre Leonard de Vinci | Dechy | France |
| Cac - Gf Leclerc | Dijon | France |
| Chu - Francois Mitterrand | Dijon | France |
| CH - | Dunkirk | France |
| CHI - Elbeuf Louviers Val de Reuil | Elbeuf | France |
| Clinique privée - CENTRE CARIO | Plérin | France |
| ID | Term |
|---|---|
| D013274 | Stomach Neoplasms |
| ID | Term |
|---|---|
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D013272 | Stomach Diseases |
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| ID | Term |
|---|---|
| D000096662 | Ramucirumab |
| D017239 | Paclitaxel |
| D000068196 | Albumin-Bound Paclitaxel |
| ID | Term |
|---|---|
| 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 |
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |
| D000418 | Albumins |
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