Phase III, Randomized, Open-label Study of Adjuvant Chemotherapy Combined With Chemoradiotherapy Versus Adujvant Chemotherapy After Standard D2 Resection for Locally Advanced Proximal Gastric Adenocarcinoma
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 408
- 试验地点
- 1
- 主要终点
- disease-free survival
研究概览
简要总结
This study evaluates the addition of adjuvant chemoradiotherapy to adjuvant chemotherapy in the treatment of locally advanced proximal gastric adenocarcinoma after standard D2 radical resection.
详细描述
Because of its special anatomical structure, local recurrence rate of locally advanced proximal gastric adenocarcinoma is still high after radical operation.
As a local/regional therapy, radiotherapy combined with concurrent chemotherapy can kill local residual tumor cells and reduce the risk of local and regional recurrence.
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Voluntary Participation and Written Signature of Informed Consent.
- •Age 18-70, gender unlimited.
- •Gross pathology confirmed that the tumor center was within 1 cm to 5 cm of the EGJ line. Histopathologically diagnosed as adenocarcinoma.
- •No neoadjuvant therapy.
- •Transabdominal standard D2 radical operation was performed and R0 resection was performed. Ascites cytology was negative.
- •The pathological stages were IIB, IIIA, IIIB and IIIC.
- •There was no intraperitoneal implantation and distant metastasis. CT should be routinely performed to evaluate the tumor bed before radiotherapy. Positron emission tomography (PET-CT) could be accepted to determine whether there was residual or distant metastasis.
- •Physical condition score ECOG 0-
- •No history of serious heart and lung diseases, abnormal hematological examination and immunodeficiency: hemoglobin (Hb) > 9 g/dL; white blood cell (WBC) > 3 x 109/L; neutrophil (ANC) > 1.5 x 109/L; platelet (Pt) > 100 x 109/L; bilirubin < 1.5 times the upper limit of normal value; glutathione transaminase (ALT) & alanine transaminase (AST) = 2.5 times the upper limit of normal value; serum creatinine < 1.5 times the normal value Upper limit.
- •No other systemic tumors were found.
- •Fertile men or women are willing to take contraceptive measures in the trial.
- •The daily energy intake is more than 1500 kcal.
排除标准
- •Those who had a history of malignant tumors (except skin basal cell carcinoma, thyroid papillary adenocarcinoma and cervical carcinoma in situ, who survived for more than 3 years after treatment).
- •Patients with a history of neoadjuvant radiotherapy and chemotherapy before operation.
- •Study participants who participated in other clinical trials within 30 days before treatment.
- •Pregnancy, lactation or fertility without contraceptive measures.
- •Drug addiction and other adverse drug addiction, long-term alcoholism and AIDS patients.
- •Those with uncontrollable infections, seizures, or loss of self-awareness due to mental illness.
- •Those with a history of severe allergy or specific constitution.
- •Researchers believe that it is not appropriate to participate in this experiment.
研究组 & 干预措施
Adujvant CT+CRT
Four to six weeks after D2 radical surgery, adjuvant chemotherapy was initiated with SOX regimen , repeated every three weeks, and adjuvant radiotherapy was started at the end of two cycles of adjuvant chemotherapy , with synchronous tegiol single drug chemotherapy. And the original SOX regimen was continued for 4 cycles after 3-4 weeks of radiotherapy.
干预措施: Adjuvant Chemoradiotherapy (Radiation)
Adujvant CT+CRT
Four to six weeks after D2 radical surgery, adjuvant chemotherapy was initiated with SOX regimen , repeated every three weeks, and adjuvant radiotherapy was started at the end of two cycles of adjuvant chemotherapy , with synchronous tegiol single drug chemotherapy. And the original SOX regimen was continued for 4 cycles after 3-4 weeks of radiotherapy.
干预措施: Adjuvant Chemotherapy (Drug)
Adujvant CT
The adjuvant chemotherapy was started 4-6 weeks after D2 radical operation. The SOX regimen was repeated every 3 weeks for 8 cycles.
干预措施: Adjuvant Chemotherapy (Drug)
结局指标
主要结局
disease-free survival
时间窗: 3 year
after primary treatment the patient survives without any signs or symptoms of cancer.
次要结局
未报告次要终点