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

RecruitingPhase 2Ages 18 Years - anyAllRutgers, The State University of New Jersey
NCT05419518 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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

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📋 Eligibility rules (as published)
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
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What it tests

  • EXTERNAL BEAM RADIATION
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Where

7 sites
RWJBarnabas Health - Robert Wood Johnson University Hospital
Hamilton, United States
RWJBarnabas Health - Monmouth Medical Center Southern Campus
Lakewood, United States
RWJBarnabas Health - Saint Barnabas Medical Center
Livingston, United States
Robert Wood Johnson University Hospital
New Brunswick, United States
Cancer Institute of New Jersey
New Brunswick, United States
RWJBarnabas Health - Robert Wood Johnson University Hospital
Somerset, United States
RWJBarnabas Health - Community Medical Center
Toms River, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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