A Phase II Randomized Study of Reirradiation for Locally Recurrent Non-Small Cell Lung Cancer
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- NRG Oncology
- 入组人数
- 138
- 主要终点
- Progression-free survival (PFS)
研究概览
简要总结
This phase II trial compares repeat radiation therapy (RT) to standard drug treatment alone in treating patients with stage II-III non-small cell lung cancer (NSCLC) that has come back after initial radiation at or adjacent to the site of the original tumor (locally recurrent). Radiation therapy uses high energy x-rays, particles, or radioactive seeds to kill cancer cells and shrink tumors. Chemotherapy drugs used in standard drug treatment work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Immunotherapy drugs used in standard drug treatment may induce changes in body's immune system and may interfere with the ability of tumor cells to grow and spread. Targeted therapy drugs used in standard treatment identify and attack specific tumor cells. This trial may help doctors determine whether repeat RT delays the cancer from growing or spreading by 6 months or more after initial radiation compared to standard drug treatment alone in patients with stage II-III locally recurrent NSCLC.
详细描述
PRIMARY OBJECTIVE:
I. In patients with NSCLC who develop locoregional disease recurrence after thoracic radiotherapy, to compare progression-free survival outcomes following curative-intent reirradiation versus systemic therapy alone.
SECONDARY OBJECTIVES:
I. To compare overall survival outcomes across study arms. II. To compare clinician-scored adverse events, scored using Common Terminology Criteria for Adverse Events (CTCAE), across study arms.
III. To compare patient-reported adverse events, scored using Patient-Reported Outcomes (PRO)-CTCAE, across study arms.
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
- •History of stage II-III NSCLC treated with fractionated (≤ 4 Gy per fraction) curative-intent (total dose ≥ 45 Gy) thoracic radiotherapy, completed ≥ 12 months before study entry
- •Participants must have recurrent/progressive disease in the lung and/or regional lymph nodes that is not suitable for treatment with stereotactic body radiation therapy (SBRT) and for which palliative thoracic radiotherapy is not required at the time of study entry
- •Biopsy to confirm recurrent/progressive disease at some point after the previous course of thoracic radiotherapy and before entering this study is required
- •A portion of the disease that would be treated with radiotherapy on Arm 2 of this protocol must fall within the 50% isodose cloud of the radiotherapy plan
- •New systemic lung cancer therapy initiated within 12 weeks prior to study entry that is still ongoing is not permitted
- •Participants must not have definitive clinical or radiographic evidence of distant metastatic NSCLC at present or in the past
- •Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-2
- •Not Pregnant and Not Nursing
- •Negative urine or serum pregnancy test (in persons of childbearing potential) within 14 days prior to registration. Childbearing potential is defined as any person who has experienced menarche and who has not undergone surgical sterilization (hysterectomy or bilateral oophorectomy) or who is not postmenopausal
- •Prior thoracic radiotherapy for NSCLC must have been delivered as definitive treatment, as opposed to in the preoperative or postoperative setting. One prior radiotherapy course must meet the specifications, and the radiotherapy plan from that course must be available in Digital Imaging and Communications in Medicine (DICOM) format
- •Patients who have received additional prior radiotherapy (i.e., more than one prior radiotherapy course) may be enrolled, provided that only one prior radiotherapy course is deemed to affect the risks associated with treatment with radiotherapy on this study. As examples, prior radiotherapy for an extrathoracic malignancy would likely not affect the risks associated with reirradiation on this study. Prior radiotherapy for breast cancer may be permissible, depending on the extent of lung irradiation. Similarly, prior SBRT for a peripheral lung tumor may be permissible
- •No prior SBRT for a central lung tumor, hilar lymph node, or mediastinal lymph node
- •Prior lobar and sublobar lung resections are allowed, but prior pneumonectomy is not allowed
- •Prior chemotherapy, targeted therapy, and/or immunotherapy for lung cancer is allowed
- •No history of CTCAE version (v.) 5.0 grade 2-4 RT pneumonitis or ongoing CTCAE v. 5.0 grade 2-4 pneumonitis from any cause
- •No clinically significant interstitial lung disease
排除标准
- 未提供
研究组 & 干预措施
Arm 2 (repeat RT, chemotherapy)
Patients undergo RT for 20 treatment fractions over approximately 5 weeks or RT for 30 treatment fractions over approximately 6 weeks in the absence of disease progression or unacceptable toxicity. Patients receiving 6-week RT may also receive chemotherapy during RT per decision of patient and doctor decision. Patients also undergo PET/CT and MRI during screening, as well as chest CT and optional blood sample collection throughout the study.
干预措施: Magnetic Resonance Imaging (Procedure)
Arm 1 (SOC systemic therapy)
Patients receive SOC systemic therapy, which may include chemotherapy, immunotherapy, and/or targeted therapy on study. Patients also undergo PET/CT and MRI during screening, as well as chest CT and optional blood sample collection throughout the study.
干预措施: Biospecimen Collection (Procedure)
Arm 1 (SOC systemic therapy)
Patients receive SOC systemic therapy, which may include chemotherapy, immunotherapy, and/or targeted therapy on study. Patients also undergo PET/CT and MRI during screening, as well as chest CT and optional blood sample collection throughout the study.
干预措施: Computed Tomography (Procedure)
Arm 1 (SOC systemic therapy)
Patients receive SOC systemic therapy, which may include chemotherapy, immunotherapy, and/or targeted therapy on study. Patients also undergo PET/CT and MRI during screening, as well as chest CT and optional blood sample collection throughout the study.
干预措施: Immunotherapy (Other)
Arm 1 (SOC systemic therapy)
Patients receive SOC systemic therapy, which may include chemotherapy, immunotherapy, and/or targeted therapy on study. Patients also undergo PET/CT and MRI during screening, as well as chest CT and optional blood sample collection throughout the study.
干预措施: Magnetic Resonance Imaging (Procedure)
Arm 1 (SOC systemic therapy)
Patients receive SOC systemic therapy, which may include chemotherapy, immunotherapy, and/or targeted therapy on study. Patients also undergo PET/CT and MRI during screening, as well as chest CT and optional blood sample collection throughout the study.
干预措施: Systemic Chemotherapy (Drug)
Arm 1 (SOC systemic therapy)
Patients receive SOC systemic therapy, which may include chemotherapy, immunotherapy, and/or targeted therapy on study. Patients also undergo PET/CT and MRI during screening, as well as chest CT and optional blood sample collection throughout the study.
干预措施: Targeted Therapy (Other)
Arm 2 (repeat RT, chemotherapy)
Patients undergo RT for 20 treatment fractions over approximately 5 weeks or RT for 30 treatment fractions over approximately 6 weeks in the absence of disease progression or unacceptable toxicity. Patients receiving 6-week RT may also receive chemotherapy during RT per decision of patient and doctor decision. Patients also undergo PET/CT and MRI during screening, as well as chest CT and optional blood sample collection throughout the study.
干预措施: Biospecimen Collection (Procedure)
Arm 2 (repeat RT, chemotherapy)
Patients undergo RT for 20 treatment fractions over approximately 5 weeks or RT for 30 treatment fractions over approximately 6 weeks in the absence of disease progression or unacceptable toxicity. Patients receiving 6-week RT may also receive chemotherapy during RT per decision of patient and doctor decision. Patients also undergo PET/CT and MRI during screening, as well as chest CT and optional blood sample collection throughout the study.
干预措施: Computed Tomography (Procedure)
Arm 2 (repeat RT, chemotherapy)
Patients undergo RT for 20 treatment fractions over approximately 5 weeks or RT for 30 treatment fractions over approximately 6 weeks in the absence of disease progression or unacceptable toxicity. Patients receiving 6-week RT may also receive chemotherapy during RT per decision of patient and doctor decision. Patients also undergo PET/CT and MRI during screening, as well as chest CT and optional blood sample collection throughout the study.
干预措施: Positron Emission Tomography (Procedure)
Arm 2 (repeat RT, chemotherapy)
Patients undergo RT for 20 treatment fractions over approximately 5 weeks or RT for 30 treatment fractions over approximately 6 weeks in the absence of disease progression or unacceptable toxicity. Patients receiving 6-week RT may also receive chemotherapy during RT per decision of patient and doctor decision. Patients also undergo PET/CT and MRI during screening, as well as chest CT and optional blood sample collection throughout the study.
干预措施: Radiation Therapy (Radiation)
Arm 2 (repeat RT, chemotherapy)
Patients undergo RT for 20 treatment fractions over approximately 5 weeks or RT for 30 treatment fractions over approximately 6 weeks in the absence of disease progression or unacceptable toxicity. Patients receiving 6-week RT may also receive chemotherapy during RT per decision of patient and doctor decision. Patients also undergo PET/CT and MRI during screening, as well as chest CT and optional blood sample collection throughout the study.
干预措施: Systemic Chemotherapy (Drug)
结局指标
主要结局
Progression-free survival (PFS)
时间窗: From randomization to the first occurrence of disease progression or death from any cause, whichever occurs first, assessed up to 5 years
The primary analysis of PFS will be conducted in the intent-to-treat population, defined as all randomized patients. The distributions of PFS will be estimated by the Kaplan-Meier method. The primary comparison between arms will use a one-sided stratified log-rank test with the randomization stratification factors. A stratified Cox proportional hazards model will be used to estimate the hazard ratio and corresponding confidence interval. An unstratified log-rank test and unstratified Cox proportional hazards model will also be provided as sensitivity analyses. No post hoc modification or collapsing of stratification categories based on observed event counts will be performed. If the stratified Cox model is not estimable because of sparse data, the unstratified Cox model will be used to summarize the treatment hazard ratio and confidence interval, with the reason documented.
次要结局
- Overall survival(From randomization to death from any cause, assessed up to 5 years)
- Incidence of clinician-scored treatment-related adverse events(Up to 5 years)
- Incidence of patient-reported adverse events(Up to 5 years)
- Site of first disease progression(Up to 5 years)