NCT03706027招募中不适用
Three- Versus Five-Fraction Regimens of Stereotactic Body Radiotherapy for Peripheral Early-Stage Non-Small-Cell Lung Cancer: A Prospective Randomized Phase II Study
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- frequency of grade 3 treatment related toxicities or higher
研究概览
简要总结
This study's goal is to find out if the kind of side effects people experience from radiation is different depending on the schedule of their radiation treatment. Patients will be randomly assigned to either the 3 Fraction or 5 Fraction schedule of radiation. After patients complete radiation treatment, they will follow up with their radiation oncologist.
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
- •Histological confirmation of non-small cell cancer will not be required as primary goal of this phase II trial is to look at toxicity. However, all primary non-small cell lung cancers otherwise of following types are eligible: squamous cell carcinoma, adenocarcinoma, large cell carcinoma, bronchioalveolar cell carcinoma, or non-small cell carcinoma not otherwise specified.
- •Eligible patients must have appropriate staging studies identifying them as specific subsets of AJCC stage I or II based on only one of the following combinations of TNM staging:
- •T1, N0, M0
- •T2 (≤ 5 cm), N0, M0
- •Patients with hilar or mediastinal lymph nodes ≤ 1cm and no abnormal hilar or mediastinal uptake on PET will be considered N
- •Patients with > 1 cm hilar or mediastinal lymph nodes on CT or abnormal PET (including suspicious but non-diagnostic uptake) may still be eligible if directed tissue biopsy of all abnormally identified areas are negative for cancer. All patients with suspicious nodes will be evaluated for mediastinal and hilar staging with bronchoscopy and (if amenable) bronchoscopic biopsy (preferably navigational biopsy and/or endobronchial US guided biopsy).
- •Zubrod performance status 0-2 within 4 weeks of study entry.
- •Women of childbearing potential and male participants must use an effective contraceptive method.
- •Evaluations required at time of study entry:
- •History & Physical by a radiation oncologist within 4 weeks of study entry;
- •Vitals within 4 weeks of study entry;
- •Evaluation by a thoracic surgeon (either via clinical examination and/or input at multidisciplinary tumor board) prior to study entry;
- •PFTs: Routine spirometry, lung volumes, diffusion capacity, and arterial blood gases within 8 weeks prior to study entry;
- •CT Chest within 6 weeks of study entry (preferably with intravenous contrast, unless medically contraindicated) - to include the entirety of both lungs, the mediastinum, liver, and adrenal glands; primary tumor dimension will be measured on this CT;
- •Whole body positron emission tomography (PET) scan using FDG with adequate visualization of the primary tumor and draining lymph node basins in the hilar and mediastinal regions within 6 weeks prior to study entry.
- •Informed consent signed by the subject and a member of the study team.
排除标准
- •Patients with central tumors. Specifically; central location implies a tumor inside the zone of the proximal bronchial tree defined as a volume 2 cm in all directions around the proximal bronchial tree (carina, right and left main bronchi, right and left upper lobe bronchi, intermedius bronchus, right middle lobe bronchus, lingular bronchus, right and left lower lobe bronchi
- •Evidence of regional or distant metastases after appropriate staging studies.
- •Synchronous primary NSCLC.
- •Those with prior malignancy in the past 2 years other than non-melanomatous skin cancer or in situ cancer or thyroid cancer.
- •Previous lung or mediastinal radiotherapy.
- •Plans for the patient to receive concomitant antineoplastic therapy (including standard fractionated radiotherapy, chemotherapy, biological therapy, vaccine therapy, and surgery) while on this protocol.
- •Patients with active systemic, pulmonary or pericardial infection.
- •Pregnant or lactating women, as treatment involves unforeseeable risks to the embryo or fetus.
研究组 & 干预措施
Stereotactic body radiotherapy- 3 fractions
Active Comparator
干预措施: radiation therapy-3 fractions (Device)
Stereotactic body radiotherapy- 5 fractions
Active Comparator
干预措施: Radiation therapy-5 fractions (Device)
结局指标
主要结局
frequency of grade 3 treatment related toxicities or higher
时间窗: 1 year
Toxicities will be assessed using the National Cancer Institute common toxicities criteria version 4.0. The rates of grade 3 or higher adverse events at 1 year will be calculated as the proportion of patients who have any adverse event of interest by the end of year 1 among the total analyzable patients in each arm.
次要结局
- mean survival time of patients with overall survival(3 years)
- proportion of patients with disease-free survival(3 years)
- proportions of patients with primary tumor control(3 years)
研究者
Deepinder P Singh, MD
Associate Professor
University of Rochester
研究点 (2)
Loading locations...
相似试验
招募中
不适用
Two-fraction Versus Five-fraction Stereotactic Radiotherapy for Localized Prostate CancerPROSTATE CANCERNCT06027892Rabin Medical Center562
招募中
3 期
Stereotactic Body Radiotherapy vs Conventional Palliative Radiotherapy for Painful Non-Spine Bone MetastasesCancer MetastaticNCT06391242Canadian Cancer Trials Group230
招募中
3 期
Palliative Steroeotactic Body Radiotherapy vs Palliative Standard Radiotherapy in Patients With Advanced Head and Neck CancerAdvanced Head and Neck CancerNCT06641791Canadian Cancer Trials Group196
进行中（未招募）
不适用
Phase II Multi-center Trial Evaluating 5 Fraction Stereotactic Partial Breast Irradiation Using GammapodBreast CancerNCT03581136University of Texas Southwestern Medical Center74
已完成
2 期
Stereotactic Radiotherapy Plus Temozolomide for Refractory Brain MetastasesBrain MetastasesNCT02654106Chinese Academy of Medical Sciences65