Palliative UNConventional Hypofractionation Trial for Metastatic Bone Disease

NCT05115331 | Active Not Recruiting Phase 3 DMC

• 1 other identifier: UCCC-RT-21-01
• Study Type: interventional
• Target: 168
• Locations: 1 country
• Sites: 1

Brief Summary

This is a randomized Phase III study evaluating the efficacy of hypofractionated and dose-escalated palliative radiation therapy in metastatic bone disease (MBD). Patients will be randomized 1:1 to the conventional (8 Gy in a single fraction) and experimental (16 Gy in 2 fractions) groups with baseline and subsequent assessment of both pain and quality of life metrics.

Conditions

Metastatic Bone Tumor

Keywords

Metastatic Bone Disease

Outcome Measures

Primary Outcomes (3)

• Pain Response measured by the Brief Pain Inventory

  A primary objective evaluate the efficacy of the addition of a second 8 Gy fraction administered 1 week following the standard 8 Gy treatment currently utilized for palliation of symptomatic bone metastases in solid cancers, as measured by pain response at 1 month. The primary endpoint for this objective is pain response which will be determined using the Brief Pain Inventory (BPI) at one month.

  1 month post radiation completion.

• Pain Response measured by the Bone Mets Pain scale

  A primary objective evaluate the efficacy of the addition of a second 8 Gy fraction administered 1 week following the standard 8 Gy treatment currently utilized for palliation of symptomatic bone metastases in solid cancers, as measured by pain response at 1 month. The primary endpoint for this objective is pain response which will be classified using the International Consensus on Palliative Radiation for Future Trials on Bone Mets, which is a 4-point scale ranging from complete response to pain progression. Pain relief as measured by this scale and daily oral morphine equivalents (OME) will be graded at 1 month.

  1 month post radiation completion.

• Safety through 30 days post-radiation

  A second primary objective is to characterize the safety profile and adverse events (AE) of dose-escalated palliative radiotherapy. The primary endpoint for this objective is Adverse events will be described and coded based upon the NCI CTCAE v5.0 through 30 days after end of a subject's treatment.

  30 days post radiation completion.

Secondary Outcomes (5)

• Time to pain relief

  2, 3, and 6 months after completion of radiation treatment.

• Quality of Life (EORTC QLQ-C30) at Baseline, 1, 3, and 6 months post treatment

  Baseline, 1, 3, and 6 months post radiation treatment.

• Quality of Life (EORTC QLQBM22) at Baseline, 1, 3, and 6 months post treatment

  Baseline, 1, 3, and 6 months post radiation treatment.

• Overall survival through 2 years post-treatment.

  2 years post treatment.

• Retreatment rates through 2 years post-treatment.

  2 years post treatment.

Study Arms (2)

Conventional Radiation Dose

ACTIVE COMPARATOR

8 Gy in a single fraction

Radiation: Conventional Radiation Dose

Experimental Radiation Dose

EXPERIMENTAL

16 Gy in 2 fractions

Radiation: Experimental Radiation Dose

Interventions

Experimental Radiation Dose RADIATION

16 Gy in 2 fractions

Experimental Radiation Dose

Conventional Radiation Dose RADIATION

8 Gy in a single fraction

Conventional Radiation Dose

Eligibility Criteria

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

You may qualify if:

• Patients must have histologically or cytologically confirmed history of solid cancer malignancy (including small cell lung cancer).
• Patients must have 1-3 new or newly painful metastatic lesions to bone as defined by CT scan, MRI, or PET scan. Lesions must be located in a long bone, pelvis/hip, spine, sacrum, or ribs. A lesion is "new" if it has occurred since any previous imaging, or if new cancer diagnosis, or new at presentation. A newly painful lesion is one that had been visible on previous imaging, but was either asymptomatic or minimally painful so that no treatment was pursued.
• There must be clearly attributable pain associated with the 1-3 new metastatic bone lesion(s) as documented on the Brief Pain Inventory and per investigator's determination that these imaging findings are consistent with the patient's described BPI pain from metastatic lesion(s).
• Age ≥18 years.
• ECOG performance status ≤3 or (Karnofsky ≥40%, see Appendix A).
• Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial in the opinion of the investigator.
• Ability to understand and the willingness to sign written informed consent.

You may not qualify if:

• Patients who have had or will have chemotherapy within 2 weeks (6 weeks for nitrosoureas or mitomycin C) prior to commencing study RT. Patients undergoing treatment with hormonal or endocrine therapies will be eligible for this trial and may continue these through study radiotherapy.
• Patients with widespread metastatic disease, such that in the opinion of the PI would preclude an investigator from determining the origin of bone disease-related pain and/or response to palliative treatment.
• Patients who are receiving any other investigational agents. Patients who have received other investigational agents previously who are no longer receiving these investigational agents may be eligible at the discretion of the PI.
• Patients with complicated bone metastases, defined as having at least one or more of the following criteria:
• Nerve root compression
• Prior radiation to the spinal cord at that bone level
• Impending (score of 9 or more on Mirel's Criteria) or existing pathologic fracture
• Spinal cord compression
• cauda equina syndrome
• Patients who have been previously radiated to the primary anatomic site for which they are being considered for this trial, or have had surgical fixation of the site. However, patients may have undergone previous courses of radiotherapy to a primary site or separate site of metastatic disease if in the opinion of the investigator the patient will be able to tolerate palliative RT.
• Patients with uncontrolled intercurrent illness.
• Pregnant women are excluded from this study.
• Life expectancy of under 3 months in the opinion of the treating investigator.
• Liquid malignancies, including myeloma, lymphoma.
• Judgment by the investigator that the patient is unsuitable to participate in the study or the patient is unlikely to comply with study procedures, restrictions and requirements.

Sponsors & Collaborators

• University of Cincinnati: lead

Study Sites (1)

University of Cincinnati

Cincinnati, Ohio, 45267, United States

Location

MeSH Terms

Conditions

Bone Neoplasms; Bone Diseases

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Musculoskeletal Diseases

Study Officials

• Timothy Struve, MD

  University of Cincinnati

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: October 15, 2021
• First Posted: November 10, 2021
• Study Start: November 24, 2021
• Primary Completion: July 13, 2023
• Study Completion: November 24, 2025
• Last Updated: May 31, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)