Palliative Dose Escalated Radiation for Painful Non-Spine Bone Metastases and Painful Non-Bone Metas
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorRutgers, The State University of New Jersey
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
EXTERNAL BEAM RADIATION
Biological/VaccineA minimum of three daily radiation therapy treatments are required in any given week. Any missed radiation treatments will be made up at the end of the treatment schedule, such that the total number of delivered 5 Gy fractions remains ten.
Treatment groups
124 Participants
are divided into 2 treatment groupsGroup A: Palliative radiation dose escalationExperimental treatment 1 intervention
Group B: Therapeutic benefitNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Safety as assessed by number of participants experiencing adverse events
Number of participants experiencing adverse effects grade three or higher, as defined by Common Terminology Criteria for Adverse Effects version 5.0 (CTCAE v5.0)
Time frame
One monthSecondary outcomes
1
Severity as assessed by number of participants experiencing toxicity and adverse events
This study will utilize the Cancer Therapy Evaluation Program Common Toxicity Criteria (CTC) Version 5.0 for toxicity and Adverse Event reporting
Time frame
One monthOther outcomes
1
Pain as assessed by number of participants experiencing pain response
will be measured according to the international consensus guidelines on palliative RT13. Pain assessment will be based on scores in Numerical Rating Pain Scale (NRPS), Visual analog scale (VAS) and Opioid analgesic use (an oral morphine equivalent dose (OMED)) in mg. Complete response is defined as a pain score of 0 on a scale from 0 to 10 and without an increase in OMED medication use. Partial response is defined as a decline of ≥2 points in pain score without analgesic increase or a decline in use of OMED of at least 25% or more from baseline without an increase in pain. Pain progression (PP) is an increase of ≥2 points without a change in OMED use or an increase of 25% or more in OMED compared with baseline with the pain score stable or one point above baseline.
Time frame
One month2
Quality-of-life (QOL) as assessed by the Brief Pain Inventory (BPI). Using the 16 item scale
Quality-of-life (QOL) instruments specific to participants with bone metastases or to those receiving palliative care have been developed in recent years. The Brief Pain Inventory (BPI) have shown excellent reliability and validity in assessing participants with bone metastases fourteen. BPI will be used for QOL assessment at baseline and one month after treatment.The BPI scale defines pain as follows: Worst Pain Score: 1 - 4 = Mild Pain. Worst Pain Score: 5 - 6 = Moderate Pain. Worst Pain Score: 7 - 10 = Severe Pain.
Time frame
One monthSponsors and contacts
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Source ClinicalTrials.gov