Neoplasm MetastasesPhase 2NCT05419518
Palliative Dose Escalated Radiation for Painful Non-Spine Bone Metastases and Painful Non-Bone Metas
A Phase 2 study testing EXTERNAL BEAM RADIATION in people with Neoplasm Metastases and Metastases, Neoplasm, run by Rutgers, The State University of New Jersey at 7 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neoplasm Metastases, Metastases, Neoplasm
- What is being tested?
- EXTERNAL BEAM RADIATION
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 124 participants
- Where
- 7 sitesUnited States
- Study dates
- 16 Mar 2023to 1 Apr 2027
- Phase
- Phase 2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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.
Who cannot join
- 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
Trial locations and contacts
7 sites in 1 country. Contact the study team or a site near you to ask about taking part.
7 sites in 1 country
United States7 sites, 7 recruiting
- Not yet recruiting
RWJBarnabas Health - Robert Wood Johnson University Hospital
Hamilton, New Jersey, 08690
Matthew P Deek, MD, 732-253-3941, Deekmp@cinj.Rutgers.edu
- Recruiting
RWJBarnabas Health - Monmouth Medical Center Southern Campus
Lakewood, New Jersey, 08701
- Recruiting
RWJBarnabas Health - Saint Barnabas Medical Center
Livingston, New Jersey, 10457
Matthew P Deek, MD, 732-253-3941, Deekmp@cinj.Rutgers.edu
- Recruiting
Robert Wood Johnson University Hospital
New Brunswick, New Jersey, 08901
- Recruiting
Cancer Institute of New Jersey
New Brunswick, New Jersey, 08903
- Recruiting
RWJBarnabas Health - Robert Wood Johnson University Hospital
Somerset, New Jersey, 08876
Matthew P Deek, MD, 732-253-3941, Deekmp@cinj.Rutgers.edu
- Recruiting
RWJBarnabas Health - Community Medical Center
Toms River, New Jersey, 08755
About this study
Official title: Palliative Dose Escalated Radiation for Painful Non-Spine Bone Metastases and Painful Non-Bone Metastases
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
Read the 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
- Conditions
- Neoplasm Metastases, Metastases, Neoplasm
- Being tested
- EXTERNAL BEAM RADIATION
- Keywords
- Metastase, Bone Neoplasms, Dose Fractionation, Radiation
- Medical subject headings
- Neoplasm Metastasis, Bone Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EXTERNAL BEAM RADIATIONBiological
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.
| Study group | Role | What they receive |
|---|---|---|
| Palliative radiation dose escalation | Experimental | 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. Receives: Biological: EXTERNAL BEAM RADIATION |
| Therapeutic benefit | No intervention | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety as assessed by number of participants experiencing adverse events
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)
Measured: One month
Secondary outcomes (1)
Severity as assessed by number of participants experiencing toxicity and adverse events
This study will utilize the Cancer Therapy Evaluation Program Common Toxicity Criteria (CTC) Version 5.0 for toxicity and Adverse Event reporting
Measured: One month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2022
- Study start16 Mar 2023
- Primary completion1 Apr 2027 (estimated)
- Study completion1 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neoplasm MetastasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- This is an, open label, single-institution, Phase II trial of palliative radiation dose escalation study for painful non-spine bone Metastases and painful non-bone metastases. Dose escalation with 2D/ 3D-CRT in ten fractions in non-spine bone metastases will be evaluated. The total dose will range from 40-50 Gy depending on normal tissue constraints. This dose in ten fractions will lead to BED10 of 56 - 75 Gy which is higher than the BED10 39 Gy with 30 Gy in ten fractions.
- Masking
- None (open label)
- Enrolment
- 124 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rutgers, The State University of New Jersey
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Matthew Pierre Deek, Rutgers, The State University of New Jersey
- Investigators
- Matthew P Deek, MD, Principal investigator, Rutgers Cancer Institute of New Jersey
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05419518
- Sponsor's protocol ID
- 152201
- Other IDs
- Pro2022000822
- Status last verified
- May 2026
- First submitted
- 10 Jun 2022
- Last updated
- 2 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No