A Prospective Randomized Trial of High Dose Versus Standard Dose Stereotactic Radiotherapy for Pain Control in Patients With Bone Metastases

NCT04063254 | Unknown Phase 2

• 1 other identifier: 201906063RINB
• Study Type: interventional
• Target: 302
• Locations: 0 countries
• Sites: N/A

Brief Summary

In the present study, we will prospectively evaluate the pain response and treatment failure rate to determine the most favorable radiation dose in single fraction stereotactic radiotherapy using the modern highly conformal technique for bone metastases. Our findings should be able to provide evidence-based recommendation to support the utilization of single fraction radiotherapy for value-based oncology practice.

Conditions

Bone Metastases; Radiotherapy Side Effect

Outcome Measures

Primary Outcomes (1)

• Effects of treatment

  To evaluate dose regimen for pain control in terms of rate of treatment failure, defined as the first occurrence of any of the following events

  3 months

Study Arms (2)

High-Dose Stereotactic Radiotherapy

EXPERIMENTAL

Radiation: Stereotactic Radiotherapy

Standard-Dose Stereotactic Radiotherapy

ACTIVE COMPARATOR

Radiation: Stereotactic Radiotherapy

Interventions

Stereotactic Radiotherapy RADIATION

High Dose (Arm A): Stereotactic radiotherapy with 12 or 16 Gy in single fraction using intensity modulated radiotherapy or volumetric modulated arc therapy (VMAT or RapidArc). Standard-dose (Arm B): Stereotactic radiotherapy with 8 or 10 Gy in single fraction using intensity modulated radiotherapy or volumetric modulated arc therapy (VMAT or RapidArc).

High-Dose Stereotactic Radiotherapy; Standard-Dose Stereotactic Radiotherapy

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with a histologic diagnosis of non-hematopoietic malignancy
• Radiographic evidence of bone metastases
• Patient with pain or dysathesia on a pain score of at least 2 by brief pain inventory survey
• Multiple osseous sites are eligible with a maximum of three separate sites irradiated concurrently
• Patients do not have prior radiotherapy or radiosurgery to the index site(s)
• Age ≥ 20 years
• Karnofsky performance status (KPS) ≥ 50%.
• Life expectancy of ≥ 3 months
• Women of childbearing potential and male participants must practice adequate contraception
• Patients must be able to comply with the study protocol, pain assessment, quality of life survey, and follow-up schedules and provide study-specific informed consent

You may not qualify if:

• Patients with radiographic impending or pathological fracture, or malignant epidural cord compression at the index site(s) indicative of upfront surgery
• Prior radiotherapy or radiosurgery to the index site(s)
• Previously treated with radioactive isotope (e.g. Ra-223) within 30 days of registration
• Inability to cooperate treatment procedure
• Severe, active comorbidities which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and adverse events of the protocol, or limit compliance with study requirements, defined as follows:
• Uncontrolled active infection requiring intravenous antibiotics at the time of registration
• Transmural myocardial infarction ≤ 6 months prior to registration
• Unstable angina or congestive heart failure requiring hospitalization ≤ 6 months prior to registration
• Life-threatening uncontrolled clinically significant cardiac arrhythmias
• Hepatic insufficiency resulting in clinical jaundice and/or coagulation defects
• Chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy at the time of registration
• Uncontrolled psychiatric disorder
• Will receive any other investigational agent or chemotherapy during treatment
• Pregnant or breast-feeding women

Sponsors & Collaborators

• National Taiwan University Hospital: lead

MeSH Terms

Conditions

Radiation Injuries

Interventions

Radiosurgery

Condition Hierarchy (Ancestors)

Wounds and Injuries

Intervention Hierarchy (Ancestors)

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

Central Study Contacts

Yun Chiang

CONTACT

0223123456; chiangyun@ntuh.gov.tw

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 19, 2019
• First Posted: August 21, 2019
• Study Start: August 30, 2019
• Primary Completion: August 30, 2021
• Study Completion: August 30, 2021
• Last Updated: August 21, 2019

Record last verified: 2019-08