drugset / Trial / NCT06942663

Randomized Phase II Trial Evaluating DFS in The Absence of an Adjuvant Component of Perioperative Chemotherapy in Patients With Gastric Cancer

NCT06942663 ↗

Phase 2 Not yet recruiting 228 enrolled Nizhny Novgorod Regional Clinical Oncology Center
RandomizedParallel-groupOpen-labelTreatment

Summary

This single-center, open-label, randomized phase II trial (JAGC-1) will evaluate whether adjuvant chemotherapy can be safely omitted in patients with stage IB-III gastric cancer (cT2-4a and/or N+) who have achieved a pathological complete response (pCR) or TRG 4-5 on the Mandard scale, following neoadjuvant chemotherapy and surgery. The study aims to compare disease-free survival and quality of life in patients receiving or not receiving adjuvant chemotherapy after neoadjuvant treatment and surgery.

Timeline

Start
2025-04-15
Primary completion
2027-11-01
Completion
2030-11-01

Drugs

EvaluationDrugModalityDoseRoute
Comparator Docetaxel Small molecule — —
Comparator Oxaliplatin Small molecule — —

Indications