NCT06942663

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

Randomized Phase II Trial Evaluating DFS in the Absence of an Adjuvant Component of Perioperative Chemotherapy in Patients With Stage IB-III Gastric Cancer Who Achieved pCR or TRG4-5 on the Mandard Scale on Neoadjuvant Chemotherapy

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 228 (estimated)
• Sponsor: Nizhny Novgorod Regional Clinical Oncology Center · Other Government
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Population: patients with localized or locally advanced gastric cancer ( cT2-4a and/or N+ according to TNM, 8th revision, 2017) after having undergone the full extent of the planned neoadjuvant component of perioperative chemotherapy, radical surgical intervention, with a histological tumor regression grade classified as pCR or TRG 4-5 according to the Mandard scale Study design Patients will be randomized in a ratio of approximately 1:1: Patients who achieve pCR will be randomly assigned to one of two groups: * Group A (no adjuvant therapy): Patients will not receive adjuvant chemotherapy * Group B (adjuvant therapy): Patients will receive the adjuvant component of perioperative chemotherapy Patients who achieve a TRG of 4-5 on the Mandard scale will be randomly assigned to one of two groups: * Group C (adjuvant therapy): Patients will not receive adjuvant chemotherapy. * Group D (no adjuvant therapy): Patients will receive the adjuvant component of perioperative chemotherapy. Patients in the groups with adjuvant therapy will receive treatment until progression or maximal effect of therapy is detected (the longest duration of treatment is 3 months).

Conditions

• Gastric Cancer

Interventions

Type	Name	Description
OTHER	Surveillance	Close monitoring for disease recurrence.
DRUG	Adjuvant Chemotherapy	The adjuvant chemotherapy regimen will be standardized based on current clinical guidelines and may include combinations of agents such as fluoropyrimidines and oxaliplatin with or without docetaxel. Treatment until the progression of the process is detected or the maximum effect of therapy is achieved (the maximum duration of treatment is 3 months).

Timeline

• Start date: 2025-04-15
• Primary completion: 2027-11-01
• Completion: 2030-11-01
• First posted: 2025-04-24
• Last updated: 2025-04-24