A phase III international randomised trial of single versus multiple fractions for re-irradiation of painful bone metastases

Phase 3

Completed

• Conditions: Bone metastases, malignancy; Cancer; Bone metastases

• Registration Number: ISRCTN48331851
• Lead Sponsor: Radiotherapy Institute Friesland (RIF) (The Netherlands)

Brief Summary

1. 2014 results in http://www.ncbi.nlm.nih.gov/pubmed/24369114 2. 2018 quality of life analysis in https://www.ncbi.nlm.nih.gov/pubmed/29188483

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2005-12-19
• Study Completion: 2007-04-01
• Last Update Posted: 12 November 2018

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 850

Inclusion Criteria

1. Patient must be 18 years of age or older at the time of randomisation
2. Patient must have histologically or cytologically proven malignancy
3. Histological diagnosis may be established from needle biopsy, bone marrow biopsy, cytology, or a surgical biopsy or resection
4. All malignant histologies/cytologies are eligible
5. Plain radiographs, radionuclide bone scans, Computed Tomography (CT) scans and/or magnetic resonance imaging confirm the presence of bone metastases corresponding to clinically painful area
6. Patient has a worst pain score of more than or equal to 2/10 as reported using the Brief Pain Inventory
7. There is no plan to make an immediate change in the analgesic regimen
8. Karnofsky Performance Status more than 50 within one week prior to randomisation
9. The interval between the last fraction of the initial radiation and the date of randomisation in this study is more than four weeks
10. Initial radiation treatment field is reproducible for re-irradiation
11. Pain is arising from the previously irradiated metastasis(es) and not from progressive disease in the adjoining or remote areas
12. Site of pain considered for palliative radiotherapy must be encompassed by the same or smaller treatment field/portal as initial treatment
13. Canada and The Netherlands only:
13.1. Patient is able (i.e. sufficiently fluent) and willing to complete the quality of life questionnaire in English, French or Dutch. The baseline assessment must already have been completed
13.2. Inability (illiteracy in English, French or Dutch, loss of sight, or other equivalent reason) to complete the questionnaires will not make the patient ineligible for the study. However, ability but unwillingness to complete the questionnaires will make the patient ineligible
14. Patient consent must be obtained according to local Institutional and/or University Human Experimentation Committee requirements. It will be the responsibility of the local participating investigators to obtain the necessary local clearance, and to indicate in writing to the National Cancer Institute of Canada Clinical Trials Group (NCIC CTG) Study Coordinator that such clearance has been obtained, before the trial can commence in that centre. Because of differing requirements, a standard consent form for the trial will not be provided. A copy of the initial full board Research Ethics Board (REB) approval and approved consent form must be sent to the central office:
14.1. The patient must sign the consent form prior to randomisation or registration
14.2. The consent form for this study must contain a statement which gives permission for the NCIC CTG and monitoring agencies to review patient records
15. Patients must be accessible for treatment and follow-up. Investigators must assure themselves that the patients randomised on this trial will be available for complete documentation of the treatment, adverse events, and follow-up.
16. In accordance with NCIC CTG policy, treatment must begin within four weeks of randomisation

Exclusion Criteria

1. Clinical or radiological evidence of spinal cord compression at the time of assessment for this study
2. Clinical or radiological evidence of pathological fractures of extremities in the area to be re-irradiated
3. Radiological evidence of high-risk lesions for pathological fractures in the extremities (lytic lesions more than 3 cm or more than 50% cortical erosion of bone diameter) and candidate for surgical intervention. Patients who are NOT surgical candidates are eligible for this study.
4. The treatment area has received prior palliative surgery
5. There is planned surgical intervention on the treated bone
6. Treatment field of initial radiation volume has to be enlarged/modified to accommodate symptomatic disease not previously irradiated, or to provide adequate treatment margin
7. Systemic radiotherapy (Sr-89) has been received within 30 days prior to randomisation
8. Patient has received half body irradiation including the current re-irradiation field within 30 days prior to randomisation

Study & Design

• Study Type: Interventional
• Study Design: Not specified