Trials / Active Not Recruiting
Active Not RecruitingNCT03760822
Second-Line Chemotherapy With Ramucirumab +/- Paclitaxel in Elderly Advanced Gastric or Gastroesophageal Junction Cancer Patients
- Status
- Active Not Recruiting
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 112 (actual)
- Sponsor
- Federation Francophone de Cancerologie Digestive · Academic / Other
- Sex
- All
- Age
- 70 Years
- Healthy volunteers
- Not accepted
Summary
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
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Ramucirumab | IV ramucirumab at 8 mg/kg on D1 and D15 |
| DRUG | Paclitaxel | IV paclitaxel at 80 mg/m² on D1, D8 and D15 |
Timeline
- Start date
- 2018-11-16
- Primary completion
- 2024-12-01
- Completion
- 2024-12-01
- First posted
- 2018-11-30
- Last updated
- 2024-07-08
Locations
38 sites across 1 country: France
Source: ClinicalTrials.gov record NCT03760822. Inclusion in this directory is not an endorsement.