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PRODIGE 55-SOCRATE : A randomized phase II study to evaluate second-line ramucirumab alone or with paclitaxel in older patients with advanced gastric cancer
EU CTIS ID: 2024-513515-27-00
What this study is testing
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.
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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
You likely can't join if
- Known brain metastasis
- History of life-threatening pulmonary embolism 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
- Child-Pugh B or C cirrhosis, or cirrhosis resulting from cirrhosis.
See the full eligibility criteria
- 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
- Known brain metastasis
- History of life-threatening pulmonary embolism 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
- Child-Pugh B or C cirrhosis, or cirrhosis resulting from cirrhosis.
- 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.
- Known allergy to paclitaxel or ramucirumab
- Other concomitant cancer or history of cancer within 5 years,
- 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
- 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.
- Previous treatment with an antiangiogenic agent
- Neuropathy grade ≥ 2 (NCI-CTCAE 4.0)
- Unresolved intestinal obstruction or sub-occlusion or inflammatory bowel disease (Crohn's, ulcerative colitis, etc.) or extensive bowel resection associated with chronic diarrhoea.
- Digestive perforation and/or fistula in the 6 months prior to randomisation
- Grade ≥ 3 digestive bleeding less than 3 months old
- 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.
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.