Dose Escalated External Beam Palliative Radiation Therapy for Controlling Pain in Patients with Bone Metastases and Non-bone Metastases

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 6 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, not breastfeeding, and at least one of the following conditions applies: * Not a woman of childbearing potential. Women are considered post-menopausal and not of child-bearing potential if they have had 12 months of natural (spontaneous) amenorrhea with an appropriate clinical profile (e.g., age appropriate, history of vasomotor symptoms) or have had surgical bilateral oophorectomy (with or without hysterectomy) at least six weeks prior to screening. In the case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow-up hormone level assessment is she considered not of child-bearing potential * 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. Highly effective contraception is defined as either: ** Total abstinence: When this is in line with the preferred and usual lifestyle of the patient. (Periodic abstinence [e.g., calendar, ovulation, symptothermal, post-ovulation methods] and withdrawal are not acceptable methods of contraception.) ** Female sterilization: When the female study patient has had surgical bilateral oophorectomy (with or without hysterectomy) or tubal ligation at least six weeks before taking study treatment. In case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow-up hormone level assessment ** Male partner sterilization (with the appropriate post-vasectomy documentation of the absence of sperm in the ejaculate). For female study patients, the vasectomized male partner should be the sole partner for that patient ** Using a combination of any two of the following: *** Placement of an intrauterine device (IUD) or intrauterine system (IUS), and *** Barrier methods of contraception: condom or occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/vaginal suppository *** Hormonal contraception methods (e.g., oral, injected, implanted)
• 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
• Patients with spinal metastasis who are receiving dose escalated radiation to another site of painful disease are eligible. These lesions can be treated with standard of care radiation doses

Exclusion Criteria

• Metastasis from a highly radiosensitive tumor (eg, lymphoma, myeloma, germ cell tumor)
• Active compression of spinal cord/cauda equina
• Previous radiation therapy (RT) or stereotatic body radiation therapy (SBRT) to the same site
• > 3 sites requiring radiation treatment