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

NCT06942663 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 228

Last updated 2025-04-24

No results posted yet for this study

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.

Conditions

Interventions

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).

Sponsors & Collaborators

  • Nizhny Novgorod Regional Clinical Oncology Center

    lead OTHER_GOV

Principal Investigators

  • Sergey Gamayunov, DMS · RESEARCH INSTITUTE OF CLINICAL ONCOLOGY "NIZHNY NOVGOROD REGIONAL CLINICAL ONCOLOGICAL DISPENSARY"

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

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

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Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06942663 on ClinicalTrials.gov