Trial Information

Investigation of Optimal Radiotherapy Regimen and Type of Irradiation 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) ;