NCT06942663Not yet recruitingPhase 2
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 · Last updated 24 Apr 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 228 (estimated)
- First submitted
- 17 Apr 2025
- Start date
- 15 Apr 2025
- Primary completion date
- 1 Nov 2027
- Lead sponsor
- Nizhny Novgorod Regional Clinical Oncology Center
- Diseases
- Gastric and esophageal cancer
- NCT number
- NCT06942663
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 228
- From 15 Apr 2025 to the primary completion date, 1 Nov 2027
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Lack of a neoadjuvant component of perioperative chemotherapy or insufficient number of courses
- The time after surgical treatment is more than 12 weeks
- Severe uncontrolled concomitant chronic or acute diseases
- The presence of a second malignant tumor (with the exception of previously cured malignant neoplasms)
Other illness
- Stage IV of the disease
- Her2-positive and/or MSI\\dMMR stomach cancer
- Any conditions that, in the opinion of the doctor, interfere with the examination procedures
Other
- With incomplete tumor response to treatment
Who the study is looking for
- \- 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.
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.