Primary or metastatic lung cancer
Conditions
Interventions
Stereotactic body radiotherapy
Sponsors
Stanford Cancer Center 875 Blake Wilbur Drive Stanford, CA 94305
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Limited primary NSCLCs (T1aN0M0, T1bN0M0, T2aN0M0, T2bN0M0, or T3N0M0) or metastatic lung tumors with no evidence of uncontrolled extrathoracic metastases. 2) Up to 4 lesions may be included. For a single lesion the sum of three orthogonal diameters can be no more than 20 cm. For multiple lesions, no lesion can have a sum of orthogonal diameters greater than 15 cm. 3) Both peripheral and central tumors are accepted for this trial. 4) Age > 18 years old 5) Both men and women and members of all races and ethnic groups are eligible for this trial. Note: Patients may be enrolled more than once (eg, for a new tumor)
Exclusion criteria
Exclusion criteria: 1) Evidence of uncontrolled extrathoracic metastases 2) Contraindication to receiving radiotherapy 3) Age < 18 years old. Children are excluded because lung malignancies rarely occur in this age group. Furthermore, treatment requires a great deal of patient cooperation including the ability to lie still for several hours in an isolated room. 4) Pregnant and breastfeeding women are excluded; as well as women of child-bearing potential who are unwilling or unable to use an acceptable method of birth control (hormonal or barrier method of birth control; abstinence) to avoid pregnancy for the duration of the study. Male subjects must also agree to use effective contraception for the same period as above. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately. 5) Prior radiation therapy is allowed but there should not be overlap with the prior high dose regions unless approved by the protocol directors.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Local tumor control of individually optimized lung tumor SABR at 12 months after treatment. Local failure will be defined as tumor biopsy and/or radiographic progression on CT and/or PET/CT. | — |
Secondary
| Measure | Time frame |
|---|---|
| Toxicity of individually optimized lung tumor SABR Feasibility of anatomically optimized AVB-coached breath-hold technique assisted by fast delivery using gated RapidArc with FFF in a subset of patients. Feasibility will be assessed based on: (1) The proportion of patients able to reproduce an anatomically-optimized breath-hold with AVB-coaching during treatment. (2) The reduction in treatment delivery time compared to gated free-breathing treatment. Metastasis free and overall survival in patients treated with SABR. | — |
Countries
Japan
Contacts
Public ContactHiroki Shirato
Hokkaido University Graduate School Graduate School of Medicine
Outcome results
None listed