Bone Metastasis, Pain
Conditions
Keywords
single bone metastasis, multiple bone metastasis, pain relief, radiotherapy
Brief summary
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.
Detailed description
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) ;
Interventions
RADIATIONRadiotherapy
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
Sponsors
International Atomic Energy Agency
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pain Relief (response rate) at 4 weeks | Up to 52 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Onset and Duration of Pain Relief in Responders | Up to 52 weeks |
| Toxicity | Up to 52 weeks |
| Quality of Life | Up to 52 weeks |
| Rates of Pathological Fractures and Spinal Cord Compression | Up to 52 weeks |
Countries
Algeria, Brazil, Egypt, India, Lithuania, Mexico, North Macedonia, Serbia, Spain, Tunisia, United Kingdom
Outcome results
None listed