Regorafenib Combined With Irinotecan as Second-line in Patients With Metastatic Gastro-oesophageal Adenocarcinomas

Conditions

• Adenocarcinoma of the Gastroesophageal Junction
• Adenocarcinoma of the Stomach

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Regorafenib and Irinotecan — COMBINATION_PRODUCT
  Irinotecan (180 mg/m² on D1 and D15 of a 4-week cycle) combined with regorafenib (160 mg daily on D2-8 and D16-22 of a 4-week cycle) administered until progression of disease or unacceptable toxicity
• Irinotecan — DRUG
  Irinotecan (180 mg/m² on D1 and D15 of a 4-week cycle) administered until progression of disease or unacceptable toxicity

Study Details

Trial evaluating the efficacy of regorafenib combined with irinotecan compared to irinotecan alone in second-line treatment of patients with metastatic gastro-oesophageal adenocarcinomas.

Key Dates

Start date

Feb 7, 2019

Status verified

Oct 2023

Primary completion

May 19, 2022

Completion

May 19, 2022

Study Design

Enrollment

89 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Regorafenib and Irinotecan
  Irinotecan 180 mg/m² on Day1 and Day 15 of a 4 week cycle combined with regorafenib 160 mg daily on Day2-8 and D16-22 of a 4 week cycle administered until progression of disease or unacceptable toxicity.
• Active Comparator: Irinotecan
  Irinotecan 180 mg/m² on Day1 and Day 15 of a 4 week cycle administered until progression of disease or unacceptable toxicity

Primary Outcome Measure

To compare the efficacy of regorafenib combined with irinotecan versus irinotecan alone in terms of overall survival (OS) [ Time Frame: expected duration of 10 months from randomisation ]