ACTIVE_NOT_RECRUITING

Palliative UNConventional Hypofractionation Trial for Metastatic Bone Disease

Conditions

Metastatic Bone Tumor Metastatic Bone Disease

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

1-2 PUNCH: Palliative UNConventional Hypofractionation Trial for Metastatic Bone Disease

Quick Facts

Study Start:2021-11-24

Study Completion:2025-11-24

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:ACTIVE_NOT_RECRUITING

Study ID

NCT05115331

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
1. Patients must have histologically or cytologically confirmed history of solid cancer malignancy (including small cell lung cancer). 2. 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. 3. 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). 4. Age ≥18 years. 5. ECOG performance status ≤3 or (Karnofsky ≥40%, see Appendix A). 6. 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. 7. Ability to understand and the willingness to sign written informed consent.	1. 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. 2. 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. 3. 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. 4. Patients with complicated bone metastases, defined as having at least one or more of the following criteria: 1. Nerve root compression 2. Prior radiation to the spinal cord at that bone level 3. Impending (score of 9 or more on Mirel's Criteria) or existing pathologic fracture 4. Spinal cord compression 5. cauda equina syndrome 5. 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. 6. Patients with uncontrolled intercurrent illness. 7. Pregnant women are excluded from this study. 8. Life expectancy of under 3 months in the opinion of the treating investigator. 9. Liquid malignancies, including myeloma, lymphoma. 10. 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.

Inclusion Criteria

Exclusion Criteria

1. Patients must have histologically or cytologically confirmed history of solid cancer malignancy (including small cell lung cancer).
2. 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.
3. 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).
4. Age ≥18 years.
5. ECOG performance status ≤3 or (Karnofsky ≥40%, see Appendix A).
6. 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.
7. Ability to understand and the willingness to sign written informed consent.

1. 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.
2. 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.
3. 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.
4. Patients with complicated bone metastases, defined as having at least one or more of the following criteria:
1. Nerve root compression
2. Prior radiation to the spinal cord at that bone level
3. Impending (score of 9 or more on Mirel's Criteria) or existing pathologic fracture
4. Spinal cord compression
5. cauda equina syndrome
5. 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.
6. Patients with uncontrolled intercurrent illness.
7. Pregnant women are excluded from this study.
8. Life expectancy of under 3 months in the opinion of the treating investigator.
9. Liquid malignancies, including myeloma, lymphoma.
10. 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.

Contacts and Locations

Principal Investigator

Timothy Struve, MD

PRINCIPAL_INVESTIGATOR

University of Cincinnati

Study Locations (Sites)

University of Cincinnati

Cincinnati, Ohio, 45267

United States

Collaborators and Investigators

Sponsor: University of Cincinnati

Timothy Struve, MD, PRINCIPAL_INVESTIGATOR, University of Cincinnati

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-11-24

Study Completion Date2025-11-24

Study Record Updates

Study Start Date2021-11-24

Study Completion Date2025-11-24

Terms related to this study

Keywords Provided by Researchers

Metastatic Bone Disease

Additional Relevant MeSH Terms

Metastatic Bone Tumor