Neoplasms

Digestive System Diseases

All Conditions

Rare Diseases

Stomach Neoplasms

Adenocarcinoma

Stomach Cancer

Antineoplastic Agents

All Drugs and Chemicals

Micronutrients

Irinotecan

Paclitaxel

Leucovorin

Fluorouracil

Albumin-Bound Paclitaxel

Ramucirumab

Tubulin Modulators

Antimitotic Agents

Angiogenesis Inhibitors

Growth Inhibitors

Ramucirumab 8 mg/kg i.v. infusion on day 1 and 15 of a 28-day cycle plus FOLFIRI (Irinotecan 180 mg/m2; i.v. bolus of 5-FU 400 mg/m2, i.v. infusion of leucovorin 400 mg/m2 , followed by a 46-hour continuous administration of 5-FU 2400 mg/m2 on day 1 and 15 of a 28-day cycle)

Ramucirumab 8 mg/kg i.v. infusion on day 1 and 15 of a 28-day cycle plus Paclitaxel 80 mg/m2 on day 1, 8, 15

Irinotecan 180 mg/m2; i.v. bolus of 5-FU 400 mg/m2, i.v. infusion of leucovorin\* 400 mg/m2 , followed by a 46-hour continuous administration of 5-FU 2400 mg/m2 on day 1 and 15 of a 28-day cycle

FOLFIRI

8 mg/kg i.v. infusion on day 1 and 15 of a 28-day cycle

Sylvie Lorenzen, Prof.

Claudia Pauligk

Daniel Pink

Peter Thuss-Patience

Peter Reichardt

Stephan Probst

Michael Stahl

Salah-Eddin Al-Batran

Eray Gökkurt

Jean-Charles Moulin

Florian Lordick

Sylvie Lorenzen

Hans-Georg Kopp

Thomas Ettrich

Carmelo Pozzo

Salah-Eddin Al-Batran, Prof

This clinical trial will evaluate whether it is beneficial in terms of prolongation of survival to combine FOLFIRI (standard treatment) with ramucirumab compared to the standard treatment of ramucirumab plus paclitaxel in patients with advanced gastric cancer after failure of one prior line of palliative chemotherapy. This trial aims to investigate the efficacy and safety of ramucirumab plus FOLFIRI (investigational arm A) compared to paclitaxel plus ramucirumab (control arm B).

Ramucirumab Plus FOLFIRI Versus Ramucirumab Plus Paclitaxel in Patients With Advanced or Metastatic Gastric Cancer, Who Failed One Prior Line of Palliative Chemotherapy

Ramucirumab Plus Irinotecan / Leucovorin / 5-FU Versus Ramucirumab Plus Paclitaxel in Patients With Advanced or Metastatic Adenocarcinoma of the Stomach or Gastroesophageal Junction, Who Failed One Prior Line of Palliative Chemotherapy - The Phase II/III RAMIRIS Study

OS Rate at 6 months is defined at the proportion of patients being known to be alive at 6 months after randomisation

duration from date of randomization to death

proportion of patients with complete or partial response (CR + PR) according to RECIST 1.1

duration from the first study drug administration to the first documented evidence of disease progression or death

proportion of patients with complete or partial response or stable disease (CR + PR + SD) according to RECIST 1.1

incidence and severity of adverse events according to CTC criteria

quality of life scores according to validated questionnaire EORTC-QLQ-C30

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Ramucirumab Plus FOLFIRI Versus Ramucirumab Plus Paclitaxel in Patients With Advanced or Metastatic Gastric Cancer, Who Failed One Prior Line of Palliative Chemotherapy	NCT03081143	Advanced Gastri...	FOLFIRI Ramucirumab Paclitaxel	18 Years -	Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest
Ramucirumab Plus FOLFIRI Versus Ramucirumab Plus Paclitaxel in Patients With Advanced or Metastatic Gastric Cancer, Who Failed One Prior Line of Palliative Chemotherapy	NCT03081143	Advanced Gastri...	FOLFIRI Ramucirumab Paclitaxel	18 Years -	Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest

Spots Global Cancer Trial Database for advanced gastric or egj cancer