Preoperative (Neoadjuvant) or Postoperative (Adjuvant) Therapy of Patients With Stages IB, II, IIIA Non-Small Cell Lung Cancer
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 250
- 主要终点
- Overall response rates
研究概览
简要总结
In this phase II study, we plan to evaluate several novel components of therapy. In patients with potentially resectable stages IIB (T3N0) and IIIA we will compare weekly paclitaxel and carboplatin with concomitant radiation therapy versus weekly paclitaxel and every 4 week carboplatin in the preoperative (neoadjuvant) setting. For patients with potentially resectable stage IB, IIA and IIB (T2N1) tumors, weekly paclitaxel and every 4 week carboplatin will be given pre-operatively (neoadjuvant). The feasibility of resection will be evaluated in the neoadjuvant group of patients. The continued study of concurrent radiation therapy with weekly paclitaxel and carboplatin will be evaluated in those patients with stage IIB (T3N0) and IIIA disease who initially had resection (adjuvant setting). Lastly, weekly paclitaxel and carboplatin every 4 weeks will be evaluated as an adjuvant program in patients who had completely resected stage IB, IIA and IIB (T2N1).
详细描述
Upon determination of eligibility, neo-adjuvant patients will be randomly assigned to one of two treatment arms:
- ARM A Paclitaxel + Carboplatin + Radiation Therapy + Surgery
- ARM B Paclitaxel + Carboplatin + Surgery
After surgery neo-adjuvant patients with a complete resection will either receive Paclitaxel + Carboplatin or no therapy, depending on their stage of disease at time of enrollment. Patients with incomplete resection Paclitaxel + Carboplatin + Radiation Therapy. Adjuvant patients who enter the study after complete resection will receive Paclitaxel + Carboplatin with or without Radiation Therapy based on initial stage of disease.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •To be included in this study, you must meet the following criteria:
- •Non-small cell lung cancer
- •Neoadjuvant candidates must have potentially resectable disease
- •Adjuvant candidates must have had complete resection
- •Clinical stage IB, II, or IIIA non-small cell lung cancer
- •ECOG performance status 0 or 1
- •Adequate bone marrow, liver and kidney function
- •No previous chemotherapy or radiation therapy for non-small cell lung cancer.
- •Give written informed consent.
排除标准
- •You cannot participate in this study if any of the following apply to you:
- •Stage IIIA with N2 nodes > 6 cm
- •Stage IIIB or IV disease
- •Age <18 years
- •ECOG performance status 2 or higher
- •Considered inoperable based on general medical condition
- •History of prior malignancy within five years
- •Women who are pregnant or lactating
- •Please note: There are additional inclusion/exclusion criteria. The study center will determine if you meet all of the criteria. If you do not qualify for the trial, study personnel will explain the reasons. If you do qualify, study personnel will explain the trial in detail and answer any questions you may have.
结局指标
主要结局
Overall response rates
次要结局
- Toxicity
- Resectability rates
- Survival
- Time to progression