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

Primary Purpose

Neoplasm Metastases, Metastases, Neoplasm

Status
Recruiting
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
EXTERNAL BEAM RADIATION
Sponsored by
Rutgers, The State University of New Jersey
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Neoplasm Metastases focused on measuring Metastase, Bone Neoplasms, Dose Fractionation, Radiation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • RWJBarnabas Health - Robert Wood Johnson University Hospital
  • RWJBarnabas Health - Saint Barnabas Medical Center
  • Robert Wood Johnson University Hospital
  • Cancer Institute of New JerseyRecruiting
  • RWJBarnabas Health - Robert Wood Johnson University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Palliative radiation dose escalation

Therapeutic benefit

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

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

Full Information

First Posted
June 10, 2022
Last Updated
September 14, 2023
Sponsor
Rutgers, The State University of New Jersey
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1. Study Identification

Unique Protocol Identification Number
NCT05419518
Brief Title
Palliative Dose Escalated Radiation for Painful Non-Spine Bone Metastases and Painful Non-Bone Metas
Official Title
Palliative Dose Escalated Radiation for Painful Non-Spine Bone Metastases and Painful Non-Bone Metastases
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 16, 2023 (Actual)
Primary Completion Date
April 1, 2024 (Anticipated)
Study Completion Date
April 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Rutgers, The State University of New Jersey

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neoplasm Metastases, Metastases, Neoplasm
Keywords
Metastase, Bone Neoplasms, Dose Fractionation, Radiation

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
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)
Allocation
Non-Randomized
Enrollment
124 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Palliative radiation dose escalation
Arm Type
Experimental
Arm Description
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.
Arm Title
Therapeutic benefit
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Biological
Intervention Name(s)
EXTERNAL BEAM RADIATION
Intervention Description
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 Outcome Measure Information:
Title
Safety as assessed by number of participants experiencing adverse events
Description
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)
Time Frame
One month
Secondary Outcome Measure Information:
Title
Severity as assessed by number of participants experiencing toxicity and adverse events
Description
This study will utilize the Cancer Therapy Evaluation Program Common Toxicity Criteria (CTC) Version 5.0 for toxicity and Adverse Event reporting
Time Frame
One month
Other Pre-specified Outcome Measures:
Title
Pain as assessed by number of participants experiencing pain response
Description
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.
Time Frame
One month
Title
Quality-of-life (QOL) as assessed by the Brief Pain Inventory (BPI). Using the 16 item scale
Description
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.
Time Frame
One month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Matthew P Deek, MD
Phone
732-253-3941
Email
Deekmp@cinj.Rutgers.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Salma Jabbour, MD
Phone
732-253-3961
Email
jabbousk@cinj.rutgers.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Matthew P Deek, MD
Organizational Affiliation
Rutgers Cancer Institute of New Jersey
Official's Role
Principal Investigator
Facility Information:
Facility Name
RWJBarnabas Health - Robert Wood Johnson University Hospital
City
Hamilton
State/Province
New Jersey
ZIP/Postal Code
08690
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Matthew P Deek, MD
Phone
732-253-3941
Email
Deekmp@cinj.Rutgers.edu
Facility Name
RWJBarnabas Health - Saint Barnabas Medical Center
City
Livingston
State/Province
New Jersey
ZIP/Postal Code
10457
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Matthew P Deek, MD
Phone
732-253-3941
Email
Deekmp@cinj.Rutgers.edu
Facility Name
Robert Wood Johnson University Hospital
City
New Brunswick
State/Province
New Jersey
ZIP/Postal Code
08901
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Cancer Institute of New Jersey
City
New Brunswick
State/Province
New Jersey
ZIP/Postal Code
08903
Country
United States
Individual Site Status
Recruiting
Facility Name
RWJBarnabas Health - Robert Wood Johnson University Hospital
City
Somerset
State/Province
New Jersey
ZIP/Postal Code
08876
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Matthew P Deek, MD
Phone
732-253-3941
Email
Deekmp@cinj.Rutgers.edu

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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