Palliative Dose Escalated Radiation for Painful Non-Spine Bone Metastases and Painful Non-Bone Metastases: A Phase II Study.
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 10-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
- Rutgers Cancer Institute of New Jersey
- Principal Investigator
- Matthew Deek
- Principal Investigator
- RWJBarnabas Health
- Community Medical Center
- Cooperman Barnabas, Livingston
- Monmouth Medical Center
- Monmouth Medical Center Vantage Point Center
- Robert Wood Johnson University Hospital, Hamilton
- Robert Wood Johnson University Hospital, Somerset
- Rutgers Cancer Institute of New Jersey-University Hospital
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
Please note that we have obtained the inclusion and exclusion criteria information from the National Institutes of Health’s clinical trials web site ClinicalTrials.gov. The listed criteria may not necessarily reflect recent amendments to the protocol and the current criteria.
For further information about clinical trials, please contact us at 732-235-7356.