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Second-Line Chemotherapy With Ramucirumab +/- Paclitaxel in Elderly Advanced Gastric or Gastroesophageal Junction Cancer Patients

NCT03760822 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 112

Last updated 2024-07-08

No results posted yet for this study

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

  • Stomach Cancer
  • Stomach Neoplasm
  • Gastric Cancer
  • Gastroesophageal Junction Adenocarcinoma

Interventions

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

Sponsors & Collaborators

  • Eli Lilly and Company

    collaborator INDUSTRY

  • Federation Francophone de Cancerologie Digestive

    lead OTHER

Principal Investigators

  • Astrid Lièvre, Pr · CHU de Pontchaillou - Rennes

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-11-16
Primary Completion
2024-12-31
Completion
2024-12-31

Countries

  • France

Study Locations

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Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03760822 on ClinicalTrials.gov