Optimization of Radiotherapy in Treatment of Painful Bone Metastasis
NCT ID: NCT00610272
Last Updated: 2013-08-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
650 participants
INTERVENTIONAL
2008-01-31
2012-08-31
Brief Summary
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Detailed Description
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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) ;
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Single Site Radiation 4Gy Fraction
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
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
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
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
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);
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
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) ;
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) ;
Interventions
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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
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
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);
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) ;
Eligibility Criteria
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Inclusion Criteria
* 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
* 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)
18 Years
ALL
No
Sponsors
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International Atomic Energy Agency
OTHER_GOV
Responsible Party
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Principal Investigators
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Elena Fidarova, MD
Role: STUDY_CHAIR
International Atomic Energy Agency
Locations
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Centre Pierre et Marie Curie, Centre hospitalier universitaire Mustapha (CHU)
Algiers, , Algeria
Irmandade de Santa Casa de Misericordia de Porto Alegre
Porto Alegre, , Brazil
Misr Oncology Center (MOC)
Cairo, , Egypt
Tata Memorial Hospital
Mumbai, , India
Institute of Oncology, University of Vilinius
Vilnius, , Lithuania
Instituto Nacional de Cancerología (INCAN)
Mexico City, , Mexico
Institute of Radiotherapy and Oncology
Skopje, , North Macedonia
Institute of Oncology and Radiology
Belgrade, , Serbia
Hospital Clinic Universidad de Barcelona
Barcelona, , Spain
Hospital Son Dureta
Palma de Mallorca, , Spain
Institut national de cancer Salah Azaiz
Tunis, , Tunisia
Mount Vernon Cancer Centre
Northwood, , United Kingdom
Countries
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References
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Salazar OM, DaMotta NW, Bridgman SM, Cardiges NM, Slawson RG. Fractionated half-body irradiation for pain palliation in widely metastatic cancers: comparison with single dose. Int J Radiat Oncol Biol Phys. 1996 Aug 1;36(1):49-60. doi: 10.1016/s0360-3016(96)00248-9.
Salazar OM, Sandhu T, da Motta NW, Escutia MA, Lanzos-Gonzales E, Mouelle-Sone A, Moscol A, Zaharia M, Zaman S. Fractionated half-body irradiation (HBI) for the rapid palliation of widespread, symptomatic, metastatic bone disease: a randomized Phase III trial of the International Atomic Energy Agency (IAEA). Int J Radiat Oncol Biol Phys. 2001 Jul 1;50(3):765-75. doi: 10.1016/s0360-3016(01)01495-x.
Mithal NP, Needham PR, Hoskin PJ. Retreatment with radiotherapy for painful bone metastases. Int J Radiat Oncol Biol Phys. 1994 Jul 30;29(5):1011-4. doi: 10.1016/0360-3016(94)90396-4.
Hoskin PJ, Price P, Easton D, Regan J, Austin D, Palmer S, Yarnold JR. A prospective randomised trial of 4 Gy or 8 Gy single doses in the treatment of metastatic bone pain. Radiother Oncol. 1992 Feb;23(2):74-8. doi: 10.1016/0167-8140(92)90338-u.
Wu JS, Wong R, Johnston M, Bezjak A, Whelan T; Cancer Care Ontario Practice Guidelines Initiative Supportive Care Group. Meta-analysis of dose-fractionation radiotherapy trials for the palliation of painful bone metastases. Int J Radiat Oncol Biol Phys. 2003 Mar 1;55(3):594-605. doi: 10.1016/s0360-3016(02)04147-0.
Gaze MN, Kelly CG, Kerr GR, Cull A, Cowie VJ, Gregor A, Howard GC, Rodger A. Pain relief and quality of life following radiotherapy for bone metastases: a randomised trial of two fractionation schedules. Radiother Oncol. 1997 Nov;45(2):109-16. doi: 10.1016/s0167-8140(97)00101-1.
Arcangeli G, Micheli A, Arcangeli G, Giannarelli D, La Pasta O, Tollis A, Vitullo A, Ghera S, Benassi M. The responsiveness of bone metastases to radiotherapy: the effect of site, histology and radiation dose on pain relief. Radiother Oncol. 1989 Feb;14(2):95-101. doi: 10.1016/0167-8140(89)90053-4.
Other Identifiers
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E33028
Identifier Type: -
Identifier Source: org_study_id