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

Metastases, Neoplasm Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05419518
• Other study ID #: 152201
• Secondary ID: Pro2022000822
• Status: Recruiting
• Phase: Phase 2
• Start date: March 16, 2023
• Est. completion date: April 1, 2024

Study information

• Verified date: November 2023
• Source: Rutgers, The State University of New Jersey
• Contact: Matthew P Deek, MD
• Phone: 732-253-3941
• Email: Deekmp[@]cinj.Rutgers.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 124
• Est. completion date: April 1, 2024
• Est. primary completion date: April 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Metastases, Neoplasm
• Neoplasm Metastases
• Neoplasm Metastasis
• Neoplasms
• Neoplasms, Second Primary

Intervention

Biological:
• EXTERNAL BEAM RADIATION
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.

Locations

Country	Name	City	State
United States	RWJBarnabas Health - Robert Wood Johnson University Hospital	Hamilton	New Jersey
United States	RWJBarnabas Health - Monmouth Medical Center Southern Campus	Lakewood	New Jersey
United States	RWJBarnabas Health - Saint Barnabas Medical Center	Livingston	New Jersey
United States	Cancer Institute of New Jersey	New Brunswick	New Jersey
United States	Robert Wood Johnson University Hospital	New Brunswick	New Jersey
United States	RWJBarnabas Health - Robert Wood Johnson University Hospital	Somerset	New Jersey
United States	RWJBarnabas Health - Community Medical Center	Toms River	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
Rutgers, The State University of New Jersey

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Pain as assessed by number of participants experiencing pain response	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.	One month
Other	Quality-of-life (QOL) as assessed by the Brief Pain Inventory (BPI). Using the 16 item scale	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.	One month
Primary	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)	One month
Secondary	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	One month