PRODIGE 55-SOCRATE : A randomized phase II study to evaluate second-line ramucirumab alone or with paclitaxel in older patients with advanced gastric cancer
Key facts
- Where
- Rennes, FranciaországSee the site
- Phase
- 2. fázis
Where in Franciaország
- Centre Hospitalier Universitaire de RennesRennes, FranciaországNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Fondation Franc.Cancerologie Digestive
- Trial code
- EU 2024-513515-27-00
- Record updated
- 2025. január 20.
- Original description
The primary objective was to assess the 6-month overall survival and 4-month quality of life of ramucirumab alone or in combination with paclitaxel.Read full original descriptionShow less
The primary objective was to assess the 6-month overall survival and 4-month quality of life of ramucirumab alone or in combination with paclitaxel.
Inclusion: Histologically proven unresectable metastatic or locally advanced gastric or oesogastric junction adenocarcinoma, regardless of HER2 status; Patient ≥ 70 years; Estimated life expectancy > 3 months; Measurable or non-measurable disease according to RECIST 1.1 criteria; Documented progression on first-line chemotherapy or within 4 months of the last cycle of fluoropyrimidine- and platinum-salt-based or irinotecan-based (with or without anthracycline) chemotherapy for metastatic or locally advanced disease, or within 6 months of the last dose of fluoropyrimidine- and platinum-salt-based adjuvant therapy (immunotherapy is permitted); Adequate haematological, renal and hepatic function; QLQ-C30 and QLQ-ELD-14; Questionnaire gériatrique IADL; Signed informed consent.
Exclusion: History of life-threatening pulmonary embolism in the 6 months prior to randomisation; Serious or unhealed wound or peptic ulcer or fracture within 28 days prior to randomisation; Radiotherapy or major surgery within 28 days prior to commencement of protocol treatment, or minor surgery/implantable chamber insertion within 7 days prior to commencement of protocol treatment; Lack of effective contraception in patients and/or their partners until at least 6 months after the end of treatment with paclitaxel; Previous treatment with taxanes; Previous treatment with an antiangiogenic agent; Digestive perforation and/or fistula in the 6 months prior to randomisation; Chronic use of antiplatelet drugs, non-steroidal anti-inflammatory drugs, dipyridamole or clopidogrel or similar agents; Any arterial thromboembolic event in the 6 months prior to randomisation; Deep vein thrombosis or pulmonary embolism, or any other significant thrombosis in the 3 months preceding the start of protocol treatment; Uncompensated congestive heart failure or uncontrolled arrhythmia; Uncontrolled arterial hypertension despite properly observed antihypertensive treatment; Known allergy to paclitaxel or ramucirumab; Other concomitant cancer or history of cancer within 5 years,; Unresolved intestinal obstruction or sub-occlusion or inflammatory bowel disease (Crohn's, ulcerative colitis, etc.) or extensive bowel resection associated with chronic diarrhoea; Grade ≥ 3 digestive bleeding less than 3 months old; Known brain metastasis; Child-Pugh B or C cirrhosis, or cirrhosis resulting from cirrhosis; Person under guardianship, curatorship, safeguard of justice or person deprived of liberty; Unable to undergo medical monitoring of the trial for geographical, social or psychological reasons; Neuropathy grade ≥ 2 (NCI-CTCAE 4.0).