Clinical trial NCT05419518: Palliative Dose Escalated Radiation for Painful Non-Spine Bone Metastases and Painful Non-Bone Metas
Official title: Palliative Dose Escalated Radiation for Painful Non-Spine Bone Metastases and Painful Non-Bone Metastases
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Neoplasm Metastases
Metastases, Neoplasm
Keywords: Metastase
Bone Neoplasms
Dose Fractionation, Radiation
Lead sponsor: Rutgers, The State University of New Jersey
Sponsor class: OTHER
First posted: 2022-06-15
Enrollment: 124
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This is an, open label, single-institution, Phase II trial of palliative radiation dose escalation study for painful non-spine bone Metastases and painful non-bone metastases.

Dose escalation with 2D/ 3D-CRT in ten fractions in non-spine bone metastases will be evaluated. The total dose will range from 40-50 Gy depending on normal tissue constraints. This dose in ten fractions will lead to BED10 of 56 - 75 Gy which is higher than the BED10 39 Gy with 30 Gy in ten fractions.
Primary purpose: TREATMENT

Brief 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

Detailed description: 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

Eligibility criteria: 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

Primary outcomes:
measure: Safety as assessed by number of participants experiencing adverse events
timeFrame: One month
Secondary outcomes:
measure: Severity as assessed by number of participants experiencing toxicity and adverse events
timeFrame: One month
Other outcomes:
measure: Pain as assessed by number of participants experiencing pain response
timeFrame: One month
measure: Quality-of-life (QOL) as assessed by the Brief Pain Inventory (BPI). Using the 16 item scale
timeFrame: One month
Locations:
city: Hamilton
country: United States
facility: RWJBarnabas Health - Robert Wood Johnson University Hospital
state: New Jersey
city: Lakewood
country: United States
facility: RWJBarnabas Health - Monmouth Medical Center Southern Campus
state: New Jersey
city: Livingston
country: United States
facility: RWJBarnabas Health - Saint Barnabas Medical Center
state: New Jersey
city: New Brunswick
country: United States
facility: Robert Wood Johnson University Hospital
state: New Jersey
city: New Brunswick
country: United States
facility: Cancer Institute of New Jersey
state: New Jersey
city: Somerset
country: United States
facility: RWJBarnabas Health - Robert Wood Johnson University Hospital
state: New Jersey
city: Toms River
country: United States
facility: RWJBarnabas Health - Community Medical Center
state: New Jersey
Study officials:
affiliation: Rutgers Cancer Institute of New Jersey
name: Matthew P Deek, MD
role: PRINCIPAL_INVESTIGATOR
References: