Optimization of Radiotherapy in Treatment of Painful Bone Metastasis

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) ;

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)