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

Cancer Clinical Trial

Official title:

A Randomized Phase 2 Study of Two Radiation Dose Schedules of Stereotactic Body Radiotherapy (SBRT) to Lung Metastases < 5cm in Dimension

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03029416
• Other study ID #: MCC-16-MULTI-21
• Secondary ID: MCC-16-LUN-101
• Status: Withdrawn
• Phase: Phase 2
• Start date: October 26, 2017
• Est. completion date: August 9, 2018

Study information

• Verified date: October 2018
• Source: University of Kentucky
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: August 9, 2018
• Est. primary completion date: July 20, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cancer
• Neoplasm Metastasis
• Radiation Therapy Complication

Intervention

Radiation:
• Stereotactic Body Radiation Therapy
Stereotactic Body Radiation Therapy using different fractionation schedules

Locations

Country	Name	City	State
United States	University of Kentucky	Lexington	Kentucky

Sponsors (1)

Lead Sponsor	Collaborator
Ronald McGarry

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Local Disease Control Rates	Response defined by the Revised Response Evaluation Criteria in Solid Tumors (RECIST) Guideline version 1.1	6 MONTHS