VOLUMES Treatment of Larger Tumor Volumes or ≥ 2 Lung Tumors Simultaneously in Lung Cancer Patients Using SBRT in a Mean-lung Dose Escalation Study
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 62
- 试验地点
- 5
- 主要终点
- MLD
研究概览
简要总结
Treatment of larger tumor volumes or ≥ 2 lung metastases simultaneously in lung cancer patient using Stereotactic Body Radiation Therapy (SBRT) in a mean-lung dose escalation study.
详细描述
A phase I/II multicenter trial will be conducted in patients with medically inoperable with peripheral non small cell lung cancer (NSCLC) > 5 cm without lymph node involvement (group A) or medically with ≥ 2 or more lung metastases (group B). Radiation pneumonitis is expected to be dose-limiting in these patients and there is evidence that the incidence is predicted by the mean lung dose (MLD). The MLD escalation will be performed separately in both patient groups, using a time-to-event continual reassessment method (TITE-CRM). All patients will receive 3-5 fractions SBRT to the lung tumor(s), with a minimum mean PTV dose ≥ 42 Gy. Fraction size may be downscaled based on the MLD constraint.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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
- •for group A and B:
- •Weight loss < 10% in the last three months.
- •WHO-performance status ≤ 2
- •Medical inoperable patients or patients refusing surgery.
- •Chemotherapy is allowed in neoadjuvant and adjuvant setting, with exclusion of the period 4 weeks pre-SBRT and 6 weeks post-SBRT.
- •Before patient registration, written informed consent must be given according to ICH/GCP, national and local regulations.
- •Risk group A specification:
- •NSCLC (Cytological or histological proven) patients with peripheral tumors >5 cm with tumor staging cT2bN0M0 or cT3N0M0 (chest wall infiltration is no
排除标准
- •, as long as the tumor diameter is > 5 cm).
- •Single peripheral lung metastasis in inoperable patients with a diameter of > 5 cm. In case of first presentation of metastatic disease, cytological or histological proof is obligated.
- •In patients without cytological or histological confirmation of NSCLC, a growing FDG-PET positive lesion (SUV >5) is accepted if a contra-indication for invasive diagnostic examination (or refusal) is present.
- •Risk group B specification:
- •Patients with ≥ 2 simultaneous peripheral lung metastases ≤ 5 cm of any origin at any location in the lung.
- •In case of first presentation of metastatic disease, cytological or histological proof is obligated. This is not necessary in case of a history of an already proven disseminated disease.
- •Patients having ≥ 2 peripheral lung metastases without unacceptable dose overlap.
- •Exclusion Criteria:
- •Patients with central tumors
- •Pancoast tumors
- •Prior radiotherapy treatment to the thorax
- •Patients receiving any systemic treatment during SBRT
- •Pregnant patients
- •Patients previously treated with adriamycin agents in case of heart involvement within the treatment field.
研究组 & 干预措施
SBRT group A
escalate MLD in medically inoperable patients with tumors larger than 5 cm in diameter (primary or solitary metastases)
干预措施: Stereotactic Body Radiotherapy (SBRT) (Radiation)
SBRT group B
Escalate the MLD in patients with ≥ 2 lung metastases
干预措施: Stereotactic Body Radiotherapy (SBRT) (Radiation)
结局指标
主要结局
MLD
时间窗: 4 years
The assessment of the maximum mean lung dose that can be safely treated with SBRT and that is associated with a 20% probability of the DLT.
次要结局
- loco-regional control(4 years)
- Quality of life assessment(2 years)
- overall survival(5 years)