Clinical trial NCT00610272: Optimization of Radiotherapy in Treatment of Painful Bone Metastasis
Official title: Investigation of Optimal Radiotherapy Regimen and Type of Irradiation in Treatment of Painful Bone Metastasis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Pain
Bone Metastasis
Keywords: single bone metastasis
multiple bone metastasis
pain relief
radiotherapy
Lead sponsor: International Atomic Energy Agency
Sponsor class: OTHER_GOV
First posted: 2008-02-07
Enrollment: 650
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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) ;

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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)

Primary outcomes:
measure: Pain Relief (response rate) at 4 weeks
timeFrame: Up to 52 weeks
Secondary outcomes:
measure: Onset and Duration of Pain Relief in Responders
timeFrame: Up to 52 weeks
measure: Toxicity
timeFrame: Up to 52 weeks
measure: Quality of Life
timeFrame: Up to 52 weeks
measure: Rates of Pathological Fractures and Spinal Cord Compression
timeFrame: Up to 52 weeks
Other outcomes:
Locations:
city: Alger
country: Algeria
facility: Centre Pierre et Marie Curie, Centre hospitalier universitaire Mustapha (CHU)
city: Porto Alegre
country: Brazil
facility: Irmandade de Santa Casa de Misericordia de Porto Alegre
city: Cairo
country: Egypt
facility: Misr Oncology Center (MOC)
city: Mumbai
country: India
facility: Tata Memorial Hospital
city: Vilnius
country: Lithuania
facility: Institute of Oncology, University of Vilinius
city: Skopje
country: Macedonia, The Former Yugoslav Republic of
facility: Institute of Radiotherapy and Oncology
city: Ciudad de Mexico
country: Mexico
facility: Instituto Nacional de Cancerología (INCAN)
city: Belgrade
country: Serbia
facility: Institute of Oncology and Radiology
city: Barcelona
country: Spain
facility: Hospital Clinic Universidad de Barcelona
city: Palma de Mallorca
country: Spain
facility: Hospital Son Dureta
city: Tunis
country: Tunisia
facility: Institut national de cancer Salah Azaiz
city: Northwood
country: United Kingdom
facility: Mount Vernon Cancer Centre
Study officials:
affiliation: International Atomic Energy Agency
name: Elena Fidarova, MD
role: STUDY_CHAIR
References:
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citation: 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.
citation: 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.
citation: 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.