Optimization of Radiotherapy in Treatment of Painful Bone Metastasis (bone mets)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
International Atomic Energy Agency
ClinicalTrials.gov Identifier:
NCT00610272
First received: January 25, 2008
Last updated: August 6, 2013
Last verified: August 2013
  Purpose

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.


Condition Intervention Phase
Pain
Bone Metastasis
Radiation: Radiotherapy
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Investigation of Optimal Radiotherapy Regimen and Type of Irradiation in Treatment of Painful Bone Metastasis

Resource links provided by NLM:


Further study details as provided by International Atomic Energy Agency:

Primary Outcome Measures:
  • Pain Relief (response rate) at 4 weeks [ Time Frame: Up to 52 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Onset and Duration of Pain Relief in Responders [ Time Frame: Up to 52 weeks ] [ Designated as safety issue: No ]
  • Toxicity [ Time Frame: Up to 52 weeks ] [ Designated as safety issue: Yes ]
  • Quality of Life [ Time Frame: Up to 52 weeks ] [ Designated as safety issue: No ]
  • Rates of Pathological Fractures and Spinal Cord Compression [ Time Frame: Up to 52 weeks ] [ Designated as safety issue: No ]

Enrollment: 650
Study Start Date: January 2008
Study Completion Date: August 2012
Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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
Radiation: 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
Active Comparator: 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
Radiation: 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
Active Comparator: 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);
Radiation: 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);
Experimental: 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) ;
Radiation: 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) ;

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00610272

Locations
Algeria
Centre Pierre et Marie Curie, Centre hospitalier universitaire Mustapha (CHU)
Alger, Algeria, 16016
Brazil
Irmandade de Santa Casa de Misericordia de Porto Alegre
Porto Alegre, Brazil, 90020-090
Egypt
Misr Oncology Center (MOC)
Cairo, Egypt
India
Tata Memorial Hospital
Mumbai, India, Maharashtra 400 012
Lithuania
Institute of Oncology, University of Vilinius
Vilnius, Lithuania, 08660
Macedonia, The Former Yugoslav Republic of
Institute of Radiotherapy and Oncology
Skopje, Macedonia, The Former Yugoslav Republic of, 1000
Mexico
Instituto Nacional de Cancerología (INCAN)
Ciudad de Mexico, Mexico, 14080
Serbia
Institute of Oncology and Radiology
Belgrade, Serbia, 11000
Spain
Hospital Clinic Universidad de Barcelona
Barcelona, Spain, 08036
Hospital Son Dureta
Palma de Mallorca, Spain, 07014
Tunisia
Institut national de cancer Salah Azaiz
Tunis, Tunisia, Bab Saadoun 1006
United Kingdom
Mount Vernon Cancer Centre
Northwood, United Kingdom, HA6 2 RN
Sponsors and Collaborators
International Atomic Energy Agency
Investigators
Study Chair: Elena Fidarova, MD International Atomic Energy Agency
  More Information

Publications:

Responsible Party: International Atomic Energy Agency
ClinicalTrials.gov Identifier: NCT00610272     History of Changes
Other Study ID Numbers: E33028
Study First Received: January 25, 2008
Last Updated: August 6, 2013
Health Authority: United Nations: International Atomic Energy Agency

Keywords provided by International Atomic Energy Agency:
single bone metastasis
multiple bone metastasis
pain relief
radiotherapy

Additional relevant MeSH terms:
Bone Marrow Diseases
Bone Neoplasms
Neoplasm Metastasis
Neoplasms, Second Primary
Bone Diseases
Hematologic Diseases
Musculoskeletal Diseases
Neoplasms
Neoplasms by Site
Neoplastic Processes
Pathologic Processes

ClinicalTrials.gov processed this record on October 22, 2014