Patient-Reported Outcomes Following Chemoradiotherapy for Locally Advanced Non-small Cell Lung Cancer: A Randomized Trial Comparing Two Radiotherapy Schedules
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 55
- 试验地点
- 2
- 主要终点
- PRO-CTCAE adverse events with score ≥ 3, observed 6 weeks after initiation of chemoradiotherapy
研究概览
简要总结
The primary objective of this study is to evaluate patient-reported outcomes during and after concurrent chemoradiotherapy for locally-advanced non-small cell lung cancer. Patients will be randomized to a standard 6-week radiotherapy course or a 4-week radiotherapy course using dose-painting based on pre-treatment Positron Emission Tomography (PET) findings.
详细描述
This study is open for patients with non-small cell lung cancer. This study offers such patients the chance for a shorter and more personalized treatment course utilizing PET imaging.
Patients will be stratified based on performance status and tumor size and randomized to one of two treatment plans:
- PET-based, dose-painted, accelerated chemoradiotherapy over 4 weeks (20 radiotherapy fractions)
- Standard chemoradiotherapy over 6 weeks (30 radiotherapy fractions)
All patients will receive standard weekly doses of chemotherapy (carboplatin and paclitaxel) during radiotherapy. This may be followed by adjuvant systemic therapy, at the discretion of the treating physicians.
All patients will undergo standard evaluations prior to enrollment, during treatment, and after treatment. Additionally, patient-reported outcomes will be assessed periodically using a Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) tool.
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
- •Pathologically proven (either histologic or cytologic) diagnosis of NSCLC with any of the following stages according to the American Joint Committee on Cancer (AJCC) Staging Manual, 7th edition,
- •Stage IIIA or IIIB
- •Stage II NSCLC with contraindication to curative surgical resection
- •Stage IV disease with solitary brain metastasis that has been treated radically (e.g.: with surgical resection and/or stereotactic radiosurgery) and thoracic disease that would be classified as stage II-III
- •Appropriate diagnostic/staging workup, including:
- •Complete history and physical examination
- •PET/CT within 42 days prior to study entry demonstrating hypermetabolic pulmonary lesion(s) and/or thoracic lymph node(s). If PET/CT was obtained more than 42 days prior to study entry and is not repeated, chest CT within 28 days prior to study entry demonstrating stable disease is required.
- •MRI of the brain or head CT with contrast within 42 days prior to study entry
- •No prior chemotherapy or thoracic radiotherapy for lung cancer
- •Eastern Cooperative Oncology Group (ECOG) Performance Status 0-2
- •Age > 18
- •Able to read and write in one of the following languages, in which the Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) tool is available: English, Danish, German, Italian, Japanese, Korean, Spanish
- •Laboratory studies obtained within 28 days prior to study entry demonstrating adequate bone marrow and end organ function
- •Women of childbearing potential must have a negative serum or urine pregnancy test within 72 hours prior to the start of study therapy, agree to utilize an adequate method of contraception throughout treatment and for at least 4 weeks after study therapy is completed, and be advised of the importance of avoiding pregnancy during trial participation and the potential risks of an unintentional pregnancy.
- •All patients must sign study specific informed consent prior to study entry.
排除标准
- •Pleural or pericardial effusion (A patient with pleural effusion may be enrolled the effusion is sampled by thoracentesis and cytology is negative or the effusion is seen on axial imaging but not on chest x-ray and deemed too small to tap under CT or ultrasound guidance.)
- •Prisoners or subjects who are compulsorily detained (involuntarily incarcerated) for treatment of either a psychiatric or physical (e.g., infectious) illness
- •Women who are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study period and for at least 4 weeks after cessation of study therapy
- •have a positive pregnancy test at baseline
- •are pregnant or breastfeeding
- •Poorly controlled diabetes (defined as fasting glucose level > 200 mg/dL) despite attempts to improve glucose control by fasting duration and adjustment of medications. Patients with diabetes will preferably be scheduled for PET/CT imaging in the morning, and instructions for fasting and use of medications will be provided in consultation with the patients' primary physicians
研究组 & 干预措施
Standard chemoradiotherapy
Patients receiving standard radiotherapy will receive a total dose of 60 Gy in 30 fractions over 6 weeks, delivered to all involved lesions (tumors and lymph nodes).
干预措施: Standard chemoradiotherapy (Combination Product)
PET-based, dose-painted, accelerated chemoradiotherapy,
For patients receiving PET-based, dose-painted, accelerated chemoradiotherapy, lesions with Metabolic Tumor Volume (MTV) exceeding 20 cc will be treated with 55 Gy in 20 fractions over 4 weeks, while lesions with MTV below 20 cc will receive 44 Gy in 20 fractions over the same 4 weeks.
干预措施: PET-based, dose-painted, accelerated chemoradiotherapy (Combination Product)
结局指标
主要结局
PRO-CTCAE adverse events with score ≥ 3, observed 6 weeks after initiation of chemoradiotherapy
时间窗: 6 Weeks after initiation of Chemoradiation
Number of Patients With PRO-CTCAE Adverse Events With Score ≥ 3
时间窗: Up to 6 Weeks after initiation of Chemoradiotherapy
Observation of Grade 3 or higher patient-reported toxicity six weeks after chemotherapy radiation was characterized utilizing the Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE). The PRO-CTCAE is a patient-reported outcome assessment tool developed by the National Cancer Institute (NCI) to capture symptomatic adverse events in patients on cancer clinical trials. Participants completed a customized PRO-CTCAE survey with 24 questions addressing 12 symptoms at baseline, every two weeks during chemoradiotherapy. The number of patients with PRO-CTCAE Grade 3 or higher adverse events was summarized by study arm for each event type.
次要结局
- Locoregional progression-free survival(Weeks 19, 32 and 45 on study)
- Progression-free survival(Weeks 19, 32 and 45 on study)
- Overall survival(From treatment start through 5 years post treatment)
- Grade 3-5 adverse events, scored using CTCAE v. 4(From treatment start through study week 45)
- PRO-CTCAE adverse events with score ≥ 3 at any time(From treatment start through study week 45)
- PRO-CTCAE adverse events with any score(From treatment start through study week 45)
- Locoregional Progression-free Survival(Weeks 19, 32, and 45 on study)
- Progression-free Survival (PFS)(Weeks 19, 32 and 45 on study)
- Overall Survival (OS)(Up to 45 weeks)
- Number of Patients With Grade 3-5 Adverse Events, Scored Using CTCAE Version 4.0(From treatment start through study week 45)
- Number of Patients With PRO-CTCAE Adverse Events With Score ≥ 3 at Any Time(From treatment start through study week 45)
- Number of Patients With PRO-CTCAE Adverse Events With Any Score(From treatment start through study week 45)