A Phase 1/2 interventional study of Stereotactic Body Radiotherapy (SBRT) and Stereotactic Body Radiotherapy (SBRT) in Lung Cancer and Metastatic Lung Cancer, sponsored by The Netherlands Cancer Institute. Completed at 5 sites in 4 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-06-27.
Sponsored by The Netherlands Cancer Institute · Phase 1/2, Interventional, and Treatment
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.
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.
7,243 studies on the registry are indexed under Lung Neoplasms; 1,557 are open to participants now.
This study's enrollment of 62 is close to the median of 60 across 5,295 interventional studies indexed under Lung Neoplasms.
Browse Lung Neoplasms studies →The Netherlands Cancer Institute is the lead sponsor of 224 studies on the registry; 66 are open to participants now.
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Risk group A specification:
Risk group B specification:
Exclusion Criteria:
escalate MLD in medically inoperable patients with tumors larger than 5 cm in diameter (primary or solitary metastases)
Radiation: Stereotactic Body Radiotherapy (SBRT)
Escalate the MLD in patients with ≥ 2 lung metastases
Radiation: Stereotactic Body Radiotherapy (SBRT)
3-5 fractions within 10-14 days
Also known as: Stereotactic Body Radiotherapy
3-5 fractions per tumor within one treatment session or sequential within one month
Also known as: Stereotactic Body Radiotherapy
MLD
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.
Time frame: 4 years
loco-regional control
Determine the local control and regional control as a function of the mean lung dose, the largest toxicity effects as a function of the MLD and the overall survival.
Time frame: 4 years
overall survival
Determine the local control and regional control as a function of the mean lung dose, the largest toxicity effects as a function of the MLD and the overall survival.
Time frame: 5 years
Quality of life assessment
valuate the increase or decrease of physical discomfort.
Time frame: 2 years
This study is completed, as verified in Oct 2017. You cannot join it, but the record below documents what was studied.
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The Netherlands Cancer Institute