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
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 228
- 主要终点
- Disease-free survival rates
研究概览
简要总结
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.
详细描述
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 component of perioperative chemotherapy, radical surgical intervention, with a histological tumor regression grade classified as pCR or TRG 4-5 according to the Mandard scale
Study design Patients will be randomized in a ratio of approximately 1:1:
Patients who achieve pCR will be randomly assigned to one of two groups:
- Group A (no adjuvant therapy): Patients will not receive adjuvant chemotherapy
- Group B (adjuvant therapy): Patients will receive the adjuvant component of perioperative chemotherapy
Patients who achieve a TRG of 4-5 on the Mandard scale will be randomly assigned to one of two groups:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •- 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.
排除标准
- •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
研究组 & 干预措施
Group A ( patients with pCR - no adjuvant therapy )
Patients will not receive adjuvant chemotherapy
干预措施: Surveillance (Other)
Group B ( patients with pCR - adjuvant therapy )
Patients will receive an adjuvant component of perioperative chemotherapy
干预措施: Adjuvant Chemotherapy (Drug)
Group C ( patients with TRG of 4-5 - no adjuvant therapy )
Patients will not receive adjuvant chemotherapy.
干预措施: Surveillance (Other)
Group D ( patients with TRG of 4-5 - adjuvant therapy )
Patients will receive an adjuvant component of perioperative chemotherapy
干预措施: Adjuvant Chemotherapy (Drug)
结局指标
主要结局
Disease-free survival rates
时间窗: 3 years
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.
次要结局
- Аssessment of the quality of life(3 years)