Pain Clinical Trial
Official title:
Investigation of Optimal Radiotherapy Regimen and Type of Irradiation in Treatment of Painful Bone Metastasis
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) ;
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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