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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) ;
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single Site Radiation 4Gy Fraction | Experimental | 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 | Active Comparator | 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 | Active Comparator | 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 | Experimental | 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) ; |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Radiotherapy | Radiation | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Pain Relief (response rate) at 4 weeks | Up to 52 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Onset and Duration of Pain Relief in Responders | Up to 52 weeks | |
| Toxicity | Up to 52 weeks | |
| Quality of Life |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Elena Fidarova, MD | International Atomic Energy Agency | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre Pierre et Marie Curie, Centre hospitalier universitaire Mustapha (CHU) | Algiers | 16016 | Algeria | |||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 8823258 | Background | 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. | |
| 11395246 | Background | 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. |
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| ID | Term |
|---|---|
| D010146 | Pain |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D011878 | Radiotherapy |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
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|
|
| Radiotherapy | Radiation | 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 | Radiation | 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 | Radiation | 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) ; |
|
| Up to 52 weeks |
| Rates of Pathological Fractures and Spinal Cord Compression | Up to 52 weeks |
| Irmandade de Santa Casa de Misericordia de Porto Alegre |
| Porto Alegre |
| 90020-090 |
| Brazil |
| Misr Oncology Center (MOC) | Cairo | Egypt |
| Tata Memorial Hospital | Mumbai | Maharashtra 400 012 | India |
| Institute of Oncology, University of Vilinius | Vilnius | 08660 | Lithuania |
| Instituto Nacional de Cancerología (INCAN) | Mexico City | 14080 | Mexico |
| Institute of Radiotherapy and Oncology | Skopje | 1000 | North Macedonia |
| Institute of Oncology and Radiology | Belgrade | 11000 | Serbia |
| Hospital Clinic Universidad de Barcelona | Barcelona | 08036 | Spain |
| Hospital Son Dureta | Palma de Mallorca | 07014 | Spain |
| Institut national de cancer Salah Azaiz | Tunis | Bab Saadoun 1006 | Tunisia |
| Mount Vernon Cancer Centre | Northwood | HA6 2 RN | United Kingdom |
| 7521863 | Background | 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. |
| 1372126 | Background | 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. |
| 12573746 | Background | 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. |
| 9423999 | Background | 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. |
| 2469105 | Background | 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. |