Status:
NOT_YET_RECRUITING
Randomized Phase II Trial Evaluating DFS in The Absence of an Adjuvant Component of Perioperative Chemotherapy in Patients With Gastric Cancer
Lead Sponsor:
Nizhny Novgorod Regional Clinical Oncology Center
Conditions:
Gastric Cancer
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
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...
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 compon...
Eligibility Criteria
Inclusion
- \- 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.
Exclusion
- 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
Key Trial Info
Start Date :
April 15 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 1 2030
Estimated Enrollment :
228 Patients enrolled
Trial Details
Trial ID
NCT06942663
Start Date
April 15 2025
End Date
November 1 2030
Last Update
April 24 2025
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