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

Conditions

• Metastases, Neoplasm
• Neoplasm Metastases

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• EXTERNAL BEAM RADIATION — BIOLOGICAL
  A 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.

Study Details

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

Key Dates

Start date

Mar 16, 2023

Status verified

May 2026

Primary completion

Apr 1, 2027

Completion

Apr 1, 2027

Study Design

Enrollment

124 participants (estimated)

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Palliative radiation dose escalation
  The prescribed dose is 50 Gy in 10 fractions. The total dose can be reduced to 40 Gy and the total number of fractions can be reduced to 8 fractions in non-spine metastases to achieve the normal tissue constraints.
• No Intervention: Therapeutic benefit
  Radiation will be delivered as per protocol. For participants experiencing unacceptable toxicity related to study treatment, yet obtaining therapeutic benefit, participants will be allowed to continue treatment, if well tolerated at the discretion of the investigator.

Primary Outcome Measure

Safety as assessed by number of participants experiencing adverse events [ Time Frame: One month ]

Central Contacts

• Matthew P Deek, MD
  732-253-3941
  [email protected]
• Salma Jabbour, MD
  732-253-3961
  [email protected]

Locations (7)

Find similar trials in Hamilton, NJ

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