RTOG 0433 - "A Phase III International Randomized Trial of Single vs. Multiple Fractions for Re-Irradiation of Painful Bone Metastases"

Treatment Plan    (Supplied Drug:  N/A)

Arm 1

8Gy (1 fx)

Arm 2 -  (Investigator's discretion)

20Gy (5 fxs)

or

20Gy (8 fxs for spine &/or whole pelvis only)

Eligibility

• Age >18.

• Histol- or cytol-proven malignancy.  Histol dx may be from needle bx, BM bx, cytology, or surgical bx or resection.  All malignant histologies/cytologies are eligible.

• Plain radiographs, radionuclide bone scans, CTs &/or MRIs confirm presence of bone mets corresponding to clinically painful area.

• Worst pain score >2/10 using Brief Pain Inventory completed by pt pre-randomiz.

• No plans for immediate change in analgesic regimen on day of randomiz.

• KPS >50 w/i 1 wk pre-randomiz.

• >4 wks between last fraction of initial RT and date of randomiz to this study.

• Initial RT field must be reproducible for re-irradiation.

• Pain must arise from previously irradiated met(s), not from progressive disease in adjoining or remote area.

• Site of pain for palliative RT must be encompassed by same or smaller tx field/portal as initial tx.

• Must be fluent and willing to complete QOL questionnaire.  Baseline asmt must already have been completed.  Inability will not make pt ineligible.  Ability, but unwillingness will make pt ineligible.

• Must be accessible for tx and follow-up.

• Tx start w/i 4 wks of randomiz.

• If site followed for this study is in ribs or extremities OR acetabulum/hip &/or proximal femur w/o the medial field border crossing midline (pubic symphysis), initial RT must have been given in single fx of 6, 7, or 8Gy; 18Gy in 4 fx; 20Gy in 5 fx; 24Gy in 6 fx; 27Gy in 8 fx; or 30Gy in 10 fx.  If site followed for this study is in spine or another area of pelvis that is not excluded from study, initial RT must have been given as a single fx of 6, 7, or 8Gy; 18Gy in 4 fx; or 20Gy in 5 fx.

• No clinical or radiological evidence of spinal cord compression.

• No clinical or radiological evidence of path fractures of extremities in area to be irradiated.

• No pts w/radiological evidence of high-risk lesions for pathological fractures in the extremities (lytic lesions >3cm or >50% cortical erosion of bone diameter) and who are surgical intervention candidates.  Pts NOT surgical candidates are eligible.

• No prior palliative surgery.

• No planned surgical intervention of treated bone.

• No tx field of initial radiation volume that must be enlarged/modified to accommodate symptomatic disease not previously irradiated, or to provide adequate tx margin.

• No systemic radiotherapy (Sr-89) w/i 30 days pre-randomiz.

• No half body RT including the current re-irradiation field w/i 30 days pre-randomiz.

• No current site already having >2 courses of RT.

• No prior admission to this study.

• No previous tx to spine or any part of pelvis encompassing small or large bowel &/or rectum w/24Gy in 6 fx, 27Gy in 8 fx or 30Gy in 10 fx.

• No pregnant or nursing women.

• PRESTUDY REQUIREMENTS:

  • Baseline characteristics

  • Karnofsky PS

  • Radiological evidence of bone mets

  • Baseline Brief Pain Inventory

  • EORTC QLQ-C30 (QOL Questionnaire)

• Signed informed consent (pre-randomiz).