Clinical trial · Interventional
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Gastric Cancer | Malignant Gastric Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Adjuvant Chemotherapy | Drug | Adjuvant Chemotherapy | ALIAS |
| Surveillance | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (4)
- type
- EXPERIMENTAL
- label
- Group A ( patients with pCR - no adjuvant therapy )
- description
- Patients will not receive adjuvant chemotherapy
- interventionNames
- Other: Surveillance
- type
- ACTIVE_COMPARATOR
- label
- Group B ( patients with pCR - adjuvant therapy )
- description
- Patients will receive an adjuvant component of perioperative chemotherapy
- interventionNames
- Drug: Adjuvant Chemotherapy
- type
- EXPERIMENTAL
- label
- Group C ( patients with TRG of 4-5 - no adjuvant therapy )
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * \- 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 Criteria: * 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
References
Publications (0)
Data not yet available