NCT02128243

Trial of S-1 Maintenance Therapy in Metastatic Esophagogastric Cancer

Randomized Controlled Trial of S-1 Maintenance Therapy in Metastatic Esophagogastric Cancer

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 242 (actual)
• Sponsor: AIO-Studien-gGmbH · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The aim is to assess the relative efficacy of S-1 de-escalation therapy vs. continuation of chemotherapy after induction therapy in patients with metastatic esophagogastric cancer in terms of overall survival.

Detailed description

Open-label, multi-center, controlled, randomized, parallel-group phase II trial in patients with metastatic esophagogastric cancer having received induction chemotherapy. Patients will be registered before or after application of a three-months induction chemotherapy . This 12-week induction therapy will consist of one of the following regimens: FLO/mod. Folfox-6, Cisplatin/5-FU, Cisplatin/S-1, FLOT, EOX/EOF or XP. Regarding dose adjustments, Investigators should refer to Section 6.3 and to the summary of product characteristics of the chemotherapeutical agents. Patients having finished the preplanned induction therapy without tumor progression (i.e. with complete remission (CR), partial remission (PR), stable disease (SD) or non-CR/non-PD in patients with non-measurable disease only according to RECIST Criteria Version 1.1) at week 12, being able to swallow capsules and having Eastern Cooperative Oncology Group (ECOG) performance score of 0-1 will be randomized in a 2:1 ratio to receive Arm A or B. In Arm A patients will continue with S-1 de-escalation phase starting at week 13 until disease progression, toxicities requiring discontinuation, withdrawal of consent, pregnancy, death or lost to follow up whichever occurs first. In patients with drug-related severe toxicity S-1 dose will be adjusted or study treatment will be terminated. In Arm B patients will continue to receive the same polychemotherapy as during induction therapy until tumor progression, toxicities requiring discontinuation, withdrawal of consent, pregnancy, death or loss to follow up whichever occurs first.

Conditions

• Unresectable, Locally Advanced or Metastatic, Adenocarcinoma of the Stomach, or of the Gastro Esophageal Junction
• Gastric Neoplasm
• Gastroesophageal Junction Adenocarcinoma
• Esophageal Adenocarcinoma
• Gastric Adenocarcinoma
• Esophageal Neoplasms

Interventions

Type	Name	Description
DRUG	S-1 de-escalation	S-1 30 mg/m² bid d1-14 q21d
DRUG	Chemotherapy by Investigator's choice	Polychemotherapy administration as in induction therapy consists of a platinum and fluoropyrimidine compound as well as optional a taxane / an anthracycline compound. Two-Drug combinations: FLO / mod. FOLFOX-6; Cisplatin, S-1; Cisplatin, 5-FU; Cisplatin, Capecitabine (XP) Three-drug combinations: EOX/EOF FLOT

Timeline

• Start date: 2014-09-01
• Primary completion: 2020-10-08
• Completion: 2020-10-08
• First posted: 2014-05-01
• Last updated: 2021-03-26

Locations

1 site across 1 country: Germany