Two Radiation Dose Schedules of SBRT to Lung Metastases < 5cm in Dimension

Ronald McGarry

Status and phase

Withdrawn

Phase 2

Conditions

Radiation Therapy Complication

Neoplasm Metastasis

Cancer

Treatments

Radiation: Stereotactic Body Radiation Therapy

Study type

Interventional

Funder types

Other

Identifiers

NCT03029416

MCC-16-MULTI-21

MCC-16-LUN-101 (Other Identifier)

Details and patient eligibility

About

30 Gy single fraction of SBRT for lung metastases will result in comparable oncologic outcomes to 18Gy in three fractions (or dosing to a BED </-100Gy at the discretion of the radiation oncologist) with respect to disease control and toxicity.

Full description

Using two different doses of SBRT, this study will examine the 6-month local disease control rate (LDCR) of the SBRT-treated metastasis to determine the optimum dosing for SBRT in pulmonary metastases. This will allow us to establish baseline SBRT data, from which we will develop a second trial to examine sequencing of immunotherapy with SBRT.

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Histological confirmation of malignant carcinoma/sarcoma (any site) with metastasis to lung.
Patients must not be eligible for therapy with curative intent (i.e. surgery, radiation, etc).
Patients must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension
Age ≥18 years
ECOG performance status >/= 2 (Karnofsky≥60%)).
Ability to understand and the willingness to sign a written informed consent document.

Exclusion criteria

Patients with more than >/=3 metastatic lung lesions or any one lesion greater than 5 cm. and/or extensive metastatic disease outside the chest.
Patients who are receiving any other investigational agents.
Patients with active systemic, pulmonary, or pericardial infection.
Pregnant or lactating women
Patients with known brain metastases should be excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events.
Uncontrolled inter-current illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
Chemotherapy concurrent with SBRT is not allowed