Daily Adaptive vs Non-Adaptive External Beam Radiation Therapy With Concurrent Chemotherapy for Locally Advanced Non-Small Cell Lung Cancer: A Prospective Randomized Trial of an Individualized Approach for Toxicity Reduction (ARTIA-Lung)
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 入组人数
- 244
- 试验地点
- 1
- 主要终点
- Acute toxicity
研究概览
简要总结
This is a prospective multi-center randomized clinical trial designed to demonstrate that daily online adaptive radiotherapy with concomitant chemotherapy for stage III non-small cell lung cancer (NSCLC) will result in decreased acute respiratory and esophageal toxicity compared with non-adaptive radiotherapy with concomitant chemotherapy. The timepoint for this assessment will be 3 months following the end of radiotherapy and will use the Patient Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE).
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
- •Provision of signed and dated informed consent form.
- •Histologically confirmed NSCLC
- •Clinical stage IIIA-IIIB (AJCC v8) disease who are either:
- •Patients classified as non-operable by the treatment team
- •Patients who refuse surgery
- •Clinical stage IIIC due to contralateral mediastinal lymph node involvement only (e.g., no contralateral hilar or any supraclavicular/cervical lymph node metastases). Mediastinal stations 2R and 4R are considered contralateral for patients whose primary tumor is within the left lung. Mediastinal stations 2L, 4L, 5, and 6 are considered contralateral for patients whose primary tumor is in the right lung.
- •Completed evaluation for metastatic disease with no distant metastases identified. Evaluation must include the following:
- •History and physical examination within 30 days prior to enrollment.
- •Whole body FDG PET-CT for staging within 60 days prior to enrollment
- •Brain MRI or contrast enhanced CT within 60 days prior to enrollment.
- •ECOG performance status 0-2 and deemed clinically fit for chemoradiotherapy.
- •Age ≥18 years (or at least the local age of consent)
- •Patients must have normal organ and marrow function.
- •Serum creatinine ≤1.5 mg/dL within 60 days prior to enrollment.
- •Measurable disease must be present.
- •Negative urine or serum pregnancy test within 14 days prior to enrollment for women of childbearing potential.
排除标准
- •Contralateral hilar or any supraclavicular/cervical lymph nodes.
- •Baseline grade ≥3 dyspnea, or cough, or dysphagia.
- •Prior invasive non-skin malignancy unless disease free for a minimum of 3 years.
- •History of prior RT to the thorax.
- •Severe imaging artifact that, in the view of the local investigator, would preclude accurate identification of the thoracic anatomy and tumor targets on the cone beam CT (e.g., artifact created implanted cardiac device in proximity to the targets).
- •Evidence of malignant pleural effusion, defined as either FDG PET avidity within effusion fluid or presence of malignant cells identified by cytology of thoracentesis fluid.
- •Severe active chronic obstructive pulmonary disease or respiratory illness other than NSCLC precluding study therapy.
- •Hospitalization for chronic obstructive pulmonary disease or respiratory illness other than NSCLC within 1 year prior to study enrollment.
- •Women of childbearing potential and sexually active women not willing or able to use contraception.
研究组 & 干预措施
Non-Adaptive Arm
Subjects in this arm will receive their radiotherapy using standard image-guided radiation therapy (IMRT) techniques. All subjects will receive standard concurrent chemotherapy and may receive adjuvant immunotherapy, if indicated.
干预措施: Chemotherapy (Drug)
Non-Adaptive Arm
Subjects in this arm will receive their radiotherapy using standard image-guided radiation therapy (IMRT) techniques. All subjects will receive standard concurrent chemotherapy and may receive adjuvant immunotherapy, if indicated.
干预措施: Immunotherapy (Drug)
Adaptive Arm
Subjects in this arm will receive their external beam radiotherapy on the Ethos Radiotherapy System version 2.0 with HyperSight cone beam computed tomography imaging, with daily online adaptation of their radiation dosimetry plan to account for day-to-day changes in the tumor and surrounding anatomical structures. All subjects will received standard concurrent chemotherapy and may receive adjuvant immunotherapy, if indicated.
干预措施: Adaptive Radiotherapy (Device)
Adaptive Arm
Subjects in this arm will receive their external beam radiotherapy on the Ethos Radiotherapy System version 2.0 with HyperSight cone beam computed tomography imaging, with daily online adaptation of their radiation dosimetry plan to account for day-to-day changes in the tumor and surrounding anatomical structures. All subjects will received standard concurrent chemotherapy and may receive adjuvant immunotherapy, if indicated.
干预措施: Chemotherapy (Drug)
Adaptive Arm
Subjects in this arm will receive their external beam radiotherapy on the Ethos Radiotherapy System version 2.0 with HyperSight cone beam computed tomography imaging, with daily online adaptation of their radiation dosimetry plan to account for day-to-day changes in the tumor and surrounding anatomical structures. All subjects will received standard concurrent chemotherapy and may receive adjuvant immunotherapy, if indicated.
干预措施: Immunotherapy (Drug)
Non-Adaptive Arm
Subjects in this arm will receive their radiotherapy using standard image-guided radiation therapy (IMRT) techniques. All subjects will receive standard concurrent chemotherapy and may receive adjuvant immunotherapy, if indicated.
干预措施: Non-Adaptive Radiotherapy (Device)
结局指标
主要结局
Acute toxicity
时间窗: From randomization to 90 days after completion of chemoradiotherapy
Composite rate of any increase in cough, or dyspnea, or dysphagia scores by 1+ using PRO-CTCAE.
次要结局
- Normal lung tissue radiation exposure(End of external beam radiation treatment (approximately 2 months from randomization))
- Lung cancer specific quality of life(From randomization to 12 months after completion of chemoradiotherapy)
- Global quality of life(From randomization to 12 months after completion of chemoradiotherapy)
- Mean normal tissue doses(End of external beam radiation treatment (approximately 2 months from randomization))
- Overall response rate(3 months, 6 months and 12 months after completion of chemoradiotherapy)
- Local progression(12 months after completion of chemoradiotherapy)
- Radiation pneumonitis(12 months after completion of chemoradiotherapy)
- Healthcare resource utilization(From the start of radiation treatment to 12 months after completion of chemoradiotherapy.)