Optimization of Radiotherapy in Treatment of Painful Bone Metastasis

International Atomic Energy Agency650 enrolled

Overview

Bone metastasis is one of the most frequent end complications of the cancer. Radiation therapy is the mainstay of treatment in this disease. Single fraction radiotherapy in both single and multiple bone metastasis is widely used, but optimization of the single dose fractionation is needed. Two different regimens of radiotherapy dose fractionation will be investigated in both single and multiple bone metastasis and endpoints will include pain relief as well as toxicity and quality of life.

PROTOCOL SCHEMA Group A Treatment of single site of painful bone metastasis: Arm 1: 4 Gy single fraction; mandate first retreatment if moderate or severe pain persists or recurs (as measured by categorical pain scale or VAS greater than 50 mm), \>4 weeks after initial RT) retreat with 8 Gy single fraction; second retreatment is optional if moderate or severe pain recurs (as measured by categorical pain scale or VAS greater than 50 mm), retreat with 8 Gy after \> 4 weeks Arm 2: 8 Gy single fraction, mandate first retreatment if moderate or severe pain persists or recurs (as measured by categorical pain scale or VAS greater than 50 mm), \>4 weeks after initial RT) retreat with 8 Gy single fraction; second retreatment is optional if moderate or severe pain recurs (as measured by categorical pain scale or VAS greater than 50 mm), retreat with 8 Gy after \> 4 weeks Group B Treatment of multiple bone metastasis: lower hemibody radiotherapy (LHBI): Arm 3: 8 Gy in a single fraction; retreatments \> 4 weeks, using local RT fields to sites of residual or recurrent, moderate or severe pain with a single fraction of 8 Gy) ; second reirradiation with 8 Gy using local RT fields optional (at discretion of PI); Arm 4: 12 Gy in 4 fractions of 3 Gy in 2 consecutive days interfraction interval of a minimum of 6 hrs; retreatments \> 4 weeks using local RT fields to sites of residual or recurrent, moderate or severe pain with a single fraction of 8 Gy); second reirradiation with 8 Gy using local RT fields optional (at discretion of PI) ;

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Conditions

Pain Bone Metastasis

Interventions

RadiotherapyRADIATION

4 Gy single fraction; mandate first retreatment if moderate or severe pain persists or recurs (as measured by categorical pain scale or VAS greater than 50 mm), \>4 weeks after initial RT) retreat with 8 Gy single fraction; second retreatment is optional if moderate or severe pain recurs (as measured by categorical pain scale or VAS greater than 50 mm), retreat with 8 Gy after \> 4 weeks

RadiotherapyRADIATION

8 Gy single fraction, mandate first retreatment if moderate or severe pain persists or recurs (as measured by categorical pain scale or VAS greater than 50 mm), \>4 weeks after initial RT) retreat with 8 Gy single fraction; second retreatment is optional if moderate or severe pain recurs (as measured by categorical pain scale or VAS greater than 50 mm), retreat with 8 Gy after \> 4 weeks

RadiotherapyRADIATION

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * histological diagnosis of malignancy associated with radiological evidence of painful bone metastasis * If patients with two sites of pain requiring separate treatment are to be entered, the same randomized treatment option will be used for both sites, but response at each site will be scored and analyzed separately. * age \> 18 years * anticipated remaining life of at least 12 weeks (3 months) * informed consent Exclusion Criteria: * Primary histology myeloma * Sites of previous RT or previous radioisotope treatment * conditions or circumstances, which may interfere with treatment or follow-up * complicated bone metastasis (pathological fractures, metastatic spinal cord compression)

Locations (12)

Centre Pierre et Marie Curie, Centre hospitalier universitaire Mustapha (CHU)

Algiers, Algeria

Irmandade de Santa Casa de Misericordia de Porto Alegre

Porto Alegre, Brazil

Misr Oncology Center (MOC)

Cairo, Egypt

Outcomes

Primary Outcomes

Pain Relief (response rate) at 4 weeks

Time frame: Up to 52 weeks

Secondary Outcomes

Onset and Duration of Pain Relief in Responders

Time frame: Up to 52 weeks

Toxicity

Time frame: Up to 52 weeks

Quality of Life

Time frame: Up to 52 weeks

Rates of Pathological Fractures and Spinal Cord Compression

Time frame: Up to 52 weeks

Data from ClinicalTrials.gov

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