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

NCT06942663 | Not Yet Recruiting Phase 2

• 1 other identifier: JAGC - 1
• Study Type: interventional
• Target: 228
• Locations: 0 countries
• Sites: N/A

Brief 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

Gastric Cancer

Outcome Measures

Primary Outcomes (1)

• Disease-free survival rates

  Comparison of 3-year DFS in the group receiving the adjuvant component of perioperative chemotherapy and in the group without it and comparison of the indicators of 3-year DFS with TRG 4-5 on the Mandard scale in the group receiving the adjuvant component of perioperative chemotherapy and in the group without it.

  3 years

Secondary Outcomes (1)

• Аssessment of the quality of life

  3 years

Study Arms (4)

Group A ( patients with pCR - no adjuvant therapy )

EXPERIMENTAL

Patients will not receive adjuvant chemotherapy

Other: Surveillance

Group B ( patients with pCR - adjuvant therapy )

ACTIVE COMPARATOR

Patients will receive an adjuvant component of perioperative chemotherapy

Drug: Adjuvant Chemotherapy

Group C ( patients with TRG of 4-5 - no adjuvant therapy )

EXPERIMENTAL

Patients will not receive adjuvant chemotherapy.

Other: Surveillance

Group D ( patients with TRG of 4-5 - adjuvant therapy )

ACTIVE COMPARATOR

Patients will receive an adjuvant component of perioperative chemotherapy

Drug: Adjuvant Chemotherapy

Interventions

Surveillance OTHER

Close monitoring for disease recurrence.

Group A ( patients with pCR - no adjuvant therapy ); Group C ( patients with TRG of 4-5 - no adjuvant therapy )

Adjuvant Chemotherapy DRUG

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).

Group B ( patients with pCR - adjuvant therapy ); Group D ( patients with TRG of 4-5 - adjuvant therapy )

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- Obtaining informed consent to participate in the study.
• Morphologically confirmed gastric adenocarcinoma.
• The presence of localized or locally advanced gastric cancer (cT2-4a and/or N+)
• The full volume of the planned neoadjuvant component of perioperative chemotherapy was performed
• Radical surgical intervention was performed for the primary tumor of gastric cancer
• The histological degree of tumor regression after surgical resection was classified TRG1 and without metastasis to regional lymph nodes N0 or TRG 4-5 based on the Mandard tumor Regression scale.
• ECOG score 0 - I.
• Absence of severe uncontrolled concomitant chronic and acute diseases.
• Adequate liver and bone marrow function
• Neutrophils \> 1.5\*109/l
• Hemoglobin \>85 g/l
• Platelets \>100\*109/l
• Increased transaminases and/or bilirubin \< 2 art.

You may not qualify if:

• Lack of a neoadjuvant component of perioperative chemotherapy or insufficient number of courses
• The time after surgical treatment is more than 12 weeks
• Stage IV of the disease
• Her2-positive and/or MSI\\dMMR stomach cancer
• Severe uncontrolled concomitant chronic or acute diseases
• The presence of a second malignant tumor (with the exception of previously cured malignant neoplasms)
• Any conditions that, in the opinion of the doctor, interfere with the examination procedures
• With incomplete tumor response to treatment

Sponsors & Collaborators

• Nizhny Novgorod Regional Clinical Oncology Center: lead

MeSH Terms

Conditions

Stomach Neoplasms

Interventions

Chemotherapy, Adjuvant

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases

Intervention Hierarchy (Ancestors)

Combined Modality Therapy; Therapeutics; Drug Therapy

Study Officials

• Sergey Gamayunov, DMS

  RESEARCH INSTITUTE OF CLINICAL ONCOLOGY "NIZHNY NOVGOROD REGIONAL CLINICAL ONCOLOGICAL DISPENSARY"

  STUDY DIRECTOR

Central Study Contacts

Petryakova Alex Julia, MD

CONTACT

79873940672; petryakovajulia@mail.ru

MIKHAIL Anat OSIPOV, MD, PhD

CONTACT

89052075653; ocipovmixail@mail.ru

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 17, 2025
• First Posted: April 24, 2025
• Study Start: April 15, 2025
• Primary Completion (Estimated): November 1, 2027
• Study Completion (Estimated): November 1, 2030
• Last Updated: April 24, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share