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NCT Number: NCT05419518

Palliative Dose Escalated Radiation for Painful Non-Spine Bone Metastases and Painful Non-Bone Metas

The investigators hypothesize that with dose escalation to 40-50 Gy in ten fractions, the complete pain response rate at one month can be increased to 40-50% in painful non-spinal bone metastases. Additionally, the investigators hypothesize that utilizing a fractionation scheme with an escalated biologically equivalent dose (BED) will result in a higher proportion of participants responding to treatment, and will also lead to more durable responses. Furthermore, the investigators hypothesize that with dose escalation to 40-50 Gy in ten fractions, the complete pain response rate at one month can be increased to 35-45% in painful non-bone metastases

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Key information

Conditions

Neoplasm Metastases Bone Diseases Bone Neoplasms Metastases, Neoplasm Musculoskeletal Diseases Neoplasm Metastasis Neoplasms Neoplasms by Site Neoplastic Processes Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

RWJBarnabas Health - Robert Wood Johnson University Hospital, Hamilton, New Jersey, United States

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About this study

The purpose of this study is to prospectively evaluate dose escalation and pain response in patients with painful non-spinal bone metastases and painful non-bone metastases treated with radiation therapy.

Primary Objective:

To evaluate improvement of complete pain response rate in painful non-spine bone metastases and painful non-bone metastases with dose escalated radiation using a ten fraction radiation regimen

Secondary Objectives:

To evaluate best pain response To evaluate mean pain scores To evaluate the duration of pain response To evaluate the changes in quality-of-life following radiation To evaluate the rates of retreatment with radiation secondary to disease or symptom progression To evaluate treatment related toxicity

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Have provided signed informed consent for the trial
  • Aged ≥18 years at the time of informed consent
  • Histologic proof of malignancy
  • Radiologic or histologic evidence of bone metastases or non-bone metastases
  • Eastern Cooperative Oncology Group (ECOG) Performance Status of ≥3
  • Pain Score ≥ 3
  • Life expectancy of six months or more
  • Willing and able to comply with all aspects of the protocol
  • A female participant is eligible to participate if she is not pregnant and not breastfeeding
  • Woman of childbearing potential who agrees to follow contraceptive guidance during the treatment period and for at least 120 days after the last dose of study treatment.
  • A male participant must agree to use contraception during the treatment period and for at least 120 days after the last dose of study treatment.

Exclusion criteria

  • Metastasis from a highly radiosensitive tumor (eg, lymphoma, myeloma, germ cell tumor)
  • Spinal metastasis
  • Active compression of spinal cord/cauda equina
  • Previous RT or SBRT to the same site
  • > 3 sites requiring radiation treatment

Treatment and study plan

EXTERNAL BEAM RADIATION

Biological

A minimum of three daily radiation therapy treatments are required in any given week. Any missed radiation treatments will be made up at the end of the treatment schedule, such that the total number of delivered 5 Gy fractions remains ten.

Primary outcomes

  1. Safety as assessed by number of participants experiencing adverse events

    Time frame: One month

    Number of participants experiencing adverse effects grade three or higher, as defined by Common Terminology Criteria for Adverse Effects version 5.0 (CTCAE v5.0)

Secondary outcomes

  1. Severity as assessed by number of participants experiencing toxicity and adverse events

    Time frame: One month

    This study will utilize the Cancer Therapy Evaluation Program Common Toxicity Criteria (CTC) Version 5.0 for toxicity and Adverse Event reporting

Other outcomes

  1. Pain as assessed by number of participants experiencing pain response

    Time frame: One month

    will be measured according to the international consensus guidelines on palliative RT13.

    Pain assessment will be based on scores in Numerical Rating Pain Scale (NRPS), Visual analog scale (VAS) and Opioid analgesic use (an oral morphine equivalent dose (OMED)) in mg.

    Complete response is defined as a pain score of 0 on a scale from 0 to 10 and without an increase in OMED medication use.

    Partial response is defined as a decline of ≥2 points in pain score without analgesic increase or a decline in use of OMED of at least 25% or more from baseline without an increase in pain.

    Pain progression (PP) is an increase of ≥2 points without a change in OMED use or an increase of 25% or more in OMED compared with baseline with the pain score stable or one point above baseline.

  2. Quality-of-life (QOL) as assessed by the Brief Pain Inventory (BPI). Using the 16 item scale

    Time frame: One month

    Quality-of-life (QOL) instruments specific to participants with bone metastases or to those receiving palliative care have been developed in recent years. The Brief Pain Inventory (BPI) have shown excellent reliability and validity in assessing participants with bone metastases fourteen. BPI will be used for QOL assessment at baseline and one month after treatment.The BPI scale defines pain as follows:

    Worst Pain Score: 1 - 4 = Mild Pain. Worst Pain Score: 5 - 6 = Moderate Pain. Worst Pain Score: 7 - 10 = Severe Pain.

Study contacts

Contact information is provided by the study sponsor or research team.

Matthew P Deek, MD

CONTACT

[email protected]

732-253-3941

Salma Jabbour, MD

CONTACT

[email protected]

732-253-3961

Sponsors and collaborators

Lead sponsor

Rutgers, The State University of New Jersey

Other

Registry information

Official study title

Palliative Dose Escalated Radiation for Painful Non-Spine Bone Metastases and Painful Non-Bone Metastases

Important dates

Study start
2023
Primary completion
2027
Study completion
2027
First posted
Jun 15, 2022
Registry last updated
Jun 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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