RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Official Title

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

Quick Facts

Study Start:2023-03-16
Study Completion:2024-04-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05419518

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Have provided signed informed consent for the trial
  2. * Aged ≥18 years at the time of informed consent
  3. * Histologic proof of malignancy
  4. * Radiologic or histologic evidence of bone metastases or non-bone metastases
  5. * Eastern Cooperative Oncology Group (ECOG) Performance Status of ≥3
  6. * Pain Score ≥ 3
  7. * Life expectancy of six months or more
  8. * Willing and able to comply with all aspects of the protocol
  9. * A female participant is eligible to participate if she is not pregnant and not breastfeeding
  10. * 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.
  11. * 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.
  1. * Metastasis from a highly radiosensitive tumor (eg, lymphoma, myeloma, germ cell tumor)
  2. * Spinal metastasis
  3. * Active compression of spinal cord/cauda equina
  4. * Previous RT or SBRT to the same site
  5. * \> 3 sites requiring radiation treatment

Contacts and Locations

Study Contact

Matthew P Deek, MD
CONTACT
732-253-3941
Deekmp@cinj.Rutgers.edu
Salma Jabbour, MD
CONTACT
732-253-3961
jabbousk@cinj.rutgers.edu

Principal Investigator

Matthew P Deek, MD
PRINCIPAL_INVESTIGATOR
Rutgers Cancer Institute of New Jersey

Study Locations (Sites)

RWJBarnabas Health - Robert Wood Johnson University Hospital
Hamilton, New Jersey, 08690
United States
RWJBarnabas Health - Monmouth Medical Center Southern Campus
Lakewood, New Jersey, 08701
United States
RWJBarnabas Health - Saint Barnabas Medical Center
Livingston, New Jersey, 10457
United States
Robert Wood Johnson University Hospital
New Brunswick, New Jersey, 08901
United States
Cancer Institute of New Jersey
New Brunswick, New Jersey, 08903
United States
RWJBarnabas Health - Robert Wood Johnson University Hospital
Somerset, New Jersey, 08876
United States
RWJBarnabas Health - Community Medical Center
Toms River, New Jersey, 08755
United States

Collaborators and Investigators

Sponsor: Rutgers, The State University of New Jersey

  • Matthew P Deek, MD, PRINCIPAL_INVESTIGATOR, Rutgers Cancer Institute of New Jersey

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-03-16
Study Completion Date2024-04-01

Study Record Updates

Study Start Date2023-03-16
Study Completion Date2024-04-01

Terms related to this study

Keywords Provided by Researchers

  • Metastase
  • Bone Neoplasms
  • Dose Fractionation, Radiation

Additional Relevant MeSH Terms

  • Neoplasm Metastases
  • Metastases, Neoplasm