Optimization of Radiotherapy in Treatment of Painful Bone Metastasis
- Conditions
- PainBone Metastasis
- Interventions
- Radiation: Radiotherapy
- Registration Number
- NCT00610272
- Lead Sponsor
- International Atomic Energy Agency
- 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) ;
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 650
- 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
- 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)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Single Site Radiation 4Gy Fraction Radiotherapy 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 Single Site Radiation 8Gy Fraction Radiotherapy 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 Multiple Sites Radiation 8Gy Fraction Radiotherapy 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); Multiple Sites Radiation 12Gy Fraction Radiotherapy 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) ;
- Primary Outcome Measures
Name Time Method Pain Relief (response rate) at 4 weeks Up to 52 weeks
- Secondary Outcome Measures
Name Time Method 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
Trial Locations
- Locations (12)
Hospital Clinic Universidad de Barcelona
🇪🇸Barcelona, Spain
Hospital Son Dureta
🇪🇸Palma de Mallorca, Spain
Irmandade de Santa Casa de Misericordia de Porto Alegre
🇧🇷Porto Alegre, Brazil
Instituto Nacional de CancerologÃa (INCAN)
🇲🇽Ciudad de Mexico, Mexico
Institute of Oncology and Radiology
🇷🇸Belgrade, Serbia
Misr Oncology Center (MOC)
🇪🇬Cairo, Egypt
Institut national de cancer Salah Azaiz
🇹🇳Tunis, Tunisia
Mount Vernon Cancer Centre
🇬🇧Northwood, United Kingdom
Centre Pierre et Marie Curie, Centre hospitalier universitaire Mustapha (CHU)
🇩🇿Alger, Algeria
Tata Memorial Hospital
🇮🇳Mumbai, India
Institute of Oncology, University of Vilinius
🇱🇹Vilnius, Lithuania
Institute of Radiotherapy and Oncology
🇲🇰Skopje, Macedonia, The Former Yugoslav Republic of