A Phase II Randomized Controlled Trial of TKI Alone Versus TKI and Local Consolidative Radiation Therapy in Oncogene Driver Mutated Oligo Metastatic Non Small Cell Lung Cancer Patients
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 106
- 试验地点
- 1
- 主要终点
- Progression Free Survival (PFS)
研究概览
简要总结
A Phase II randomized controlled trial of TKI Alone versus TKI and Local Consolidative Radiation Therapy in oncogene driver mutated oligo metastatic Non-small cell lung cancer patients.
详细描述
Randomization Arms: Eligible patients will be randomized in 1:1 ratio to TKI alone or TKI + LCRT. This will be an intention to treat randomized study.
Arm 1: Continuation of TKI therapy alone Arm 2: Continuation of TKI therapy + Local Consolidative Radiation therapy to loc0-regional disease and 1-5 oligometastatic sites
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 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with pathologically proven diagnosis of NSCLC
- •Patients with positive oncogene driver mutation (EGFR or ALK/ROS)
- •Patients who have received at least 2-4 months of TKI therapy without progression
- •Patients with 1-5 sites of metastatic disease not including the primary tumor and regional nodes (less than 3 metastatic lesions in one organ will be eligible and 4 or more metastatic lesions in one organ will be ineligible)
- •Patients suitable for local consolidative therapy
- •Adequate end-organ function CBC/differential obtained within 15 days prior to registration on study, with adequate bone marrow function defined as follows:
- •Absolute neutrophil count (ANC) ≥ 500 cells/mm3;
- •Platelets ≥ 50,000 cells/mm3;
- •Hemoglobin ≥ 8.0 g/dl (Use of transfusion or other intervention to achieve Hgb ≥ 8.0 g/dl is acceptable);
- •Patients with ECOG performance status of 0-2
- •Age > 18 years
- •For females of child-bearing potential, negative serum or urine pregnancy test within 14 days prior to study registration
排除标准
- •Patients with progressive disease after 2-3 months of initial TKI therapy
- •Patients with negative oncogene driver mutations (EGFR/ALK/ROS)
- •Patients not suitable for local consolidative radiation therapy
- •Patients who are not suitable for further continuation of TKI therapy due to toxicity
- •Severe, active co-morbidity defined as follows:
- •Unstable angina and/or congestive heart failure requiring hospitalization within the last 6 months;
- •Transmural myocardial infarction within the last 6 months;
- •Chronic Obstructive Pulmonary Disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy at the time of registration;
- •Patients with prior history of radiation therapy to thorax
- •Patients with second malignancy (Synchronous or Metachronous)
研究组 & 干预措施
Arm 1: Continuation of TKI therapy alone
Patients in this arm will continue to receive standard treatment of TKI alone
干预措施: TKI (Drug)
Arm 2: Continuation of TKI therapy + Local Consolidative Radiation therapy to 1-5 sites
Patients will receive local consolidate radiation therapy to all oligo-metastatic sites plus radiation therapy to primary disease in addition to TKI
干预措施: Local Consolidative Radiation Therapy (Radiation)
Arm 2: Continuation of TKI therapy + Local Consolidative Radiation therapy to 1-5 sites
Patients will receive local consolidate radiation therapy to all oligo-metastatic sites plus radiation therapy to primary disease in addition to TKI
干预措施: TKI (Drug)
结局指标
主要结局
Progression Free Survival (PFS)
时间窗: Upto 2 years
Progression Free Survival will be defined as the time from the date of randomization until the date of disease recurrence or progression is documented, or until death in the absence of recurrence, whichever is earlier.
次要结局
- Local control rates(Upto 2 years)
- Toxicities using CTC v5.0 (radiotherapy related)(From time of Randomization to time of death or up to 24 months)
- Overall survival (OS)(Upto 2 years)
- Health Related Quality of Life using the EORTC-LC13 questionnaire(From time of randomization to time of death or up to 24 months)
- Health Related Quality of Life using the EORTC-QLQ-C30 questionnaire(From time of randomization to time of death or up to 24 months)
研究者
Anil Tibdewal
Principal investigator
Tata Memorial Hospital