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

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

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

Conditions3

Locations7 sites

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