Lung Cancer
Conditions
Brief summary
This study has two primary objectives. The first objective is to determine the maximal tolerated dose (MTD) that can be delivered with stereotactic radiosurgery in patients with inoperable malignant lung tumors. Once the MTD is established, the second objective is to determine the efficacy of radiosurgical ablation of lung tumors in terms of symptoms and radiographic responses.
Interventions
PROCEDUREStereotactic radiosurgery
Sponsors
Stanford University
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1.Lung tumor \>= 5.0 cm. 2.Age \> 18 years, 3.Histologic confirmation of malignancy (primary lung or metastatic tumor) 4.Deemed unresectable either by radiographic criteria (such as direct invasion of the mediastinum, heart, great vessels, or trachea), by virtue of excessive risk to patient, patient refusal to undergo surgery, or prior operative findings. 5.Performance status of 0-2 by Eastern Clinical Oncology Group criteria
Exclusion criteria
1. No chemotherapy within 2 weeks of radiation treatment. 2\. Refusal to sign informed consent. 3\. Refusal to take a pregnancy test prior to treatment if the patient is a woman with child bearing potential.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Maximal tolerated dose (MTD) that can be delivered with stereotactic radiosurgery in patients with inoperable malignant lung tumors | — |
| Efficacy of radiosurgical ablation of lung tumors in terms of symptoms and radiographic responses | — |
Countries
United States
Outcome results
None listed