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

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

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

The purpose of this study is to prospectively evaluate dose escalation and pain response in patients with painful non-spinal bone metastases and painful non-bone metastases treated with radiation therapy.

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 ten 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

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