Gastric Cancer Clinical Trial
— SOCRATEOfficial title:
Second-Line Chemotherapy With Ramucirumab +/- Paclitaxel in Elderly Advanced Gastric or Gastroesophageal Junction Cancer Patients
Verified date | August 2023 |
Source | Federation Francophone de Cancerologie Digestive |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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: - Six months survival rate - Quality of life at 4 months as assessed by the following three target dimensions of the EORTC QLQ-ELD14 questionnaire: mobility, illness burden and worries about the future
Status | Active, not recruiting |
Enrollment | 112 |
Est. completion date | September 2024 |
Est. primary completion date | December 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 70 Years and older |
Eligibility | 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: - ANC = 1 500 / mm3, platelets = 100 000 / mm3, hemoglobin = 9 g/dL - Blood creatinine = 1.5 x ULN and creatinine clearance (MDRD formula) = 40 mL/min - Total bilirubin = 1.5 x ULN, AST and ALT = 3 x ULN (= 5 x ULN if hepatic metastasis) - INR = 1.5 or INR = 3 for patients taking AVK and PTT = 5 seconds above the ULN - Dipstick proteinuria = 1+ or 24 hour proteinuria < 1 g in total - 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: - Known cerebral metastasis - Prior treatment by taxanes - Prior treatment with an antiangiogenic - Neuropathy of grade = 2 (NCI-CTCAE 4.0) - Unresolved partial or total bowel obstruction, inflammatory bowel disease (such as Crohn's disease or ulcerative colitis) or extensive gastrointestinal (GI) resection combined with chronic diarrhea - GI perforation and/or fistulae in the 6 months preceding randomization. - GI bleeding within the last 3 months of grade = 3 (NCI-CTCAE 4.0) - Chronic use of antiplatelet drugs (including aspirin, but a daily intake of = 325 mg/day is accepted), non-steroidal anti-inflammatory drugs (ibuprofen, naproxen), dipyridamole, clopidogrel or similar agents - Any arterial thromboembolic event (such as myocardial infarction, unstable angina, cerebrovascular accident or transient ischemic attack) in the 6 months preceding randomization - A life-threatening episode of pulmonary embolism in the 6 months preceding randomization - Deep-vein thrombosis, pulmonary embolism (PE), or any other significant thromboembolism (venous port or catheter thrombosis or superficial venous thrombosis are not considered "significant" during the 3 months prior to first dose of protocol therapy - Uncompensated congestive heart failure or uncontrolled arrhythmia - Uncontrolled hypertension (= 140/90 mm Hg for > 4 weeks) despite properly observed antihypertensive therapy - Cirrhosis at a level of Chilg-Pugh B or C; or cirrhosis (any degree) with a history of hepatic encephalopathy or clinically meaningful ascites resulting from cirrhosis. Clinically meaningful ascites is defined as ascites from cirrhosis requiring diuretics or paracentesis - Serious or unhealed wound, peptic ulcer or fracture within 28 days of randomization - Radiotherapy or major surgery within 28 days of prior to first dose of protocol therapy, or minor surgery/subcutaneous venous access device placement within 7 days prior the first dose of protocol therapy - Known allergy to paclitaxel or ramucirumab - Another concomitant cancer or a history of cancer in the last 5 years, except cervical carcinoma in situ, cutaneous basal-cell or squamous-cell carcinoma, or any other carcinoma in situ deemed to be successfully treated - Lack of effective contraception in patients (man and/or women) of childbearing age, and/or their - Persons deprived of liberty or under supervision - Impossibility of undergoing medical monitoring during the trial for geographic, social or psychological reasons |
Country | Name | City | State |
---|---|---|---|
France | CH - | Abbeville | |
France | CH - Albi | 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-Jallieu | |
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 - | Dunkerque | |
France | CHI - Elbeuf Louviers Val de Reuil | Elbeuf | |
France | Clinique privée - CENTRE CARIO | Plérin |
Lead Sponsor | Collaborator |
---|---|
Federation Francophone de Cancerologie Digestive | Eli Lilly and Company |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Patient survival rate at 6 months | Rate of patients alive | at 6 months | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Secondary | Overall survival | Defined as time to death (whatever cause is) or for patients alive time to last news. | 6 months | |
Secondary | Time to treatment failure | Time between randomization and disease progression, treatment interruption or death | 6 months | |
Secondary | Progression-free survival | Progression-free survival (clinical and/or radiological) determined by the investigator based on RECIST V1.1 | 6 months |
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