Optimization of Radiotherapy in Treatment of Painful Bone Metastasis

NCT00610272 | Completed Phase 3 DMC

• 1 other identifier: E33028
• Study Type: interventional
• Target: 650
• Locations: 11 countries
• Sites: 12

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.

Conditions

Pain; Bone Metastasis

Keywords

single bone metastasis; multiple bone metastasis; pain relief; radiotherapy

Outcome Measures

Primary Outcomes (1)

• Pain Relief (response rate) at 4 weeks

  Up to 52 weeks

Secondary Outcomes (4)

• 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

Study Arms (4)

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

Radiation: Radiotherapy

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

Radiation: Radiotherapy

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);

Radiation: Radiotherapy

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) ;

Radiation: Radiotherapy

Interventions

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

Single Site Radiation 4Gy Fraction

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• International Atomic Energy Agency: lead

Study Sites (12)

Centre Pierre et Marie Curie, Centre hospitalier universitaire Mustapha (CHU)

Algiers, 16016, Algeria

Location

Irmandade de Santa Casa de Misericordia de Porto Alegre

Porto Alegre, 90020-090, Brazil

Location

Misr Oncology Center (MOC)

Cairo, Egypt

Location

Tata Memorial Hospital

Mumbai, Maharashtra 400 012, India

Location

Institute of Oncology, University of Vilinius

Vilnius, 08660, Lithuania

Location

Instituto Nacional de Cancerología (INCAN)

Mexico City, 14080, Mexico

Location

Institute of Radiotherapy and Oncology

Skopje, 1000, North Macedonia

Location

Institute of Oncology and Radiology

Belgrade, 11000, Serbia

Location

Hospital Clinic Universidad de Barcelona

Barcelona, 08036, Spain

Location

Hospital Son Dureta

Palma de Mallorca, 07014, Spain

Location

Institut national de cancer Salah Azaiz

Tunis, Bab Saadoun 1006, Tunisia

Location

Mount Vernon Cancer Centre

Northwood, HA6 2 RN, United Kingdom

Location

Related Publications (7)

• 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.

  PMID: 8823258 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.

  PMID: 11395246 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.

  PMID: 7521863 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.

  PMID: 1372126 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.

  PMID: 12573746 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.

  PMID: 9423999 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.

  PMID: 2469105 BACKGROUND

MeSH Terms

Conditions

Pain

Interventions

Radiotherapy

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

• Elena Fidarova, MD

  International Atomic Energy Agency

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 25, 2008
• First Posted: February 7, 2008
• Study Start: January 1, 2008
• Primary Completion: April 1, 2012
• Study Completion: August 1, 2012
• Last Updated: August 7, 2013

Record last verified: 2013-08

Locations

TU (1); IN (1); GB (1); SE (1); EG (1); BR (1); LI (1); ME (1); NO (1); AL (1); ES (2)