Adjuvant Chemotherapy Versus Observation in Fully Resected Stage I Lung Adenocarcinoma With High Risk of Post-operative Recurrence
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Recurrence free survival (RFS)
研究概览
简要总结
This is a clinical trial from Eastern Cooperative Thoracic Oncology Project (ECTOP), numbered as ECTOP-1004. Solid subtype, micropapillary subtype, vascular involvement, pleural involvement and low differentiation are high risk factors of post-operative recurrence for early-stage lung adenocarcinoma patients. The purpose of this clinical trial is to determine whether the widely used adjuvant chemotherapy strategy cisplatin/ pemetrexed is more effective than no further treatment for Stage pI lung adenocarcinoma patients with high post-operative recurrence risk - in terms of no dose related toxicities, premature treatment withdrawal or death.
详细描述
Background:
Management of lung cancer varies according to the clinical and pathological stage. For stage I lung adenocarcinoma, radical surgery is the preferred initial treatment and adjuvant chemotherapy is usually not recommended due to a fine prognosis and relatively low post-operative recurrence rate. Still, a number of stage pI patients will suffer a relapse after surgery, among which are highly associated with solid subtype, micropapillary subtype, vascular involvement, pleural involvement and low differentiation. Recently, some retrospective researches have shown a significant survival benefit of adjuvant chemotherapy for such stage pI high-recurrent-risk patients, but there lacks evidence from prospective randomized clinical trails.
Objective:
- Major: to compare disease free survival and over all survival of fully resected stage pI high-recurrent-risk patients from both arms (adjuvant chemotherapy vs. observation)
- To assess the safety and efficacy of chemotherapy regimen cisplatin plus pemetrexed to fully resected stage pI high-recurrent-risk patients.
- To collect clinical pathological characteristics and prognosis information of stage pI patients with solid subtype, micropapillary subtype, vascular involvement, pleural involvement and low differentiation.
- To determine the association among age, gender, smoking history, pathological subtypes, histological differentiation, pleural involvement, vascular involvement and driving mutations.
Randomization:
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
- •Stage pI lung adenocarcinoma confirmed through formalin-fixed paraffin-embedded tumor tissue, complete resection with mediastinal lymph node dissection
- •Meet one of following conditions: a, Solid predominant adenocarcinomas; b, micropapillary predominant adenocarcinoma; c, low differentiation, unable to identify histological subtypes; d, pleural involvement; e, vascular involvement with solid subtype component or micropapillary component.
- •Aged 18-70 years old.
- •Eastern Cooperative Oncology Group score standard (ECOG) status 0-
- •Medical condition permits adjuvant chemotherapy.
- •Patients accept the clinical trial protocol and Informed Consent Form (ICF) signed.
排除标准
- •Concurrent other malignancies
- •Prior chemotherapy and/or radiation therapy for lung cancer
- •Central type lung cancer
- •Concurrent other unresected suspicious nodules or masses in lung
- •Medical condition that will not permit treatment or follow up according to the protocol, or ECOG status >
- •Pregnant or nursing women.
研究组 & 干预措施
Cisplatin plus pemetrexed
Drug: cisplatin 75mg/m2 iv Drug: pemetrexed 500mg/m2 iv
干预措施: cisplatin plus pemetrexed (Drug)
结局指标
主要结局
Recurrence free survival (RFS)
时间窗: up to 5 years
from date of randomization until the date of showing signs of relapse, including evidence of medical image or pathology.
次要结局
- Overall survival (OS)(up to 5 years)
研究者
Haiquan Chen
Chief,department of thoracic surgery, Fudan University Shanghai Cancer Center
Fudan University