RecruitingPhase 2

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

United States124 participantsStarted 2023-03-16

Plain-language 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

Who can participate

Age range18 Years

SexALL

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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

What they're measuring

Safety as assessed by number of participants experiencing adverse events

Timeframe: One month

Trial details

NCT IDNCT05419518

SponsorRutgers, The State University of New Jersey

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-04-01

Contact for this trial

Matthew P Deek, MD

732-253-3941 Deekmp@cinj.Rutgers.edu