Palliative Dose Escalated Radiation for Painful Non-Spine Bone Metastases and Painful Non-Bone Metastases
Trial Snapshot
- Phase
- Phase 2
- Status
- Recruiting
- Enrollment
- 124
- Locations
- 7
- Primary Endpoint
- Safety as assessed by number of participants experiencing adverse events
Study Overview
Brief Summary
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
Detailed Description
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
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Therapeutic benefit
Radiation will be delivered as per protocol. For participants experiencing unacceptable toxicity related to study treatment, yet obtaining therapeutic benefit, participants will be allowed to continue treatment, if well tolerated at the discretion of the investigator.
Palliative radiation dose escalation
The prescribed dose is 50 Gy in 10 fractions. The total dose can be reduced to 40 Gy and the total number of fractions can be reduced to 8 fractions in non-spine metastases to achieve the normal tissue constraints.
Intervention: EXTERNAL BEAM RADIATION (Biological)
Outcomes
Primary Outcomes
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
- Severity as assessed by number of participants experiencing toxicity and adverse events(One month)
Investigators
Matthew Pierre Deek
Assistant Professor, Radiation Oncology
Rutgers, The State University of New Jersey