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

NCT03029416 | Withdrawn Phase 2 DMC

• 2 other identifiers: MCC-16-MULTI-21MCC-16-LUN-101
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Neoplasm Metastasis; Cancer; Radiation Therapy Complication

Outcome Measures

Primary Outcomes (1)

• Local Disease Control Rates

  Response defined by the Revised Response Evaluation Criteria in Solid Tumors (RECIST) Guideline version 1.1

  6 MONTHS

Study Arms (2)

Single Fraction of SBRT

EXPERIMENTAL

Stereotactic Body Radiation Therapy delivered in a single session on one day

Radiation: Stereotactic Body Radiation Therapy

Fractionated SBRT

EXPERIMENTAL

Stereotactic Body Radiation Therapy delivered in three to five fractions with one fraction delivered every other day

Radiation: Stereotactic Body Radiation Therapy

Interventions

Stereotactic Body Radiation Therapy RADIATION

Stereotactic Body Radiation Therapy using different fractionation schedules

Fractionated SBRT; Single Fraction of SBRT

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Ronald McGarry: lead

Study Sites (1)

University of Kentucky

Lexington, Kentucky, 40536, United States

Location

MeSH Terms

Conditions

Neoplasm Metastasis; Neoplasms

Interventions

Radiosurgery

Condition Hierarchy (Ancestors)

Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Radiotherapy; Therapeutics; Stereotaxic Techniques; Neurosurgical Procedures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Ronald McGarry, MD

  University of Kentucky

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 30 Gy single fraction SBRT 18 Gy x three fractions

Study Record Dates

• First Submitted: January 20, 2017
• First Posted: January 24, 2017
• Study Start: October 26, 2017
• Primary Completion: July 20, 2018
• Study Completion: August 9, 2018
• Last Updated: October 15, 2018

Record last verified: 2018-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)