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

Trans Tasman Radiation Oncology Group (TROG) 03.08 - A phase III international randomized trial of single versus multiple fractions for re-irradiation of painful bone metastases from any cancer to increase pain relief

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12607000064404

Acronym

TROG 03.08

Enrollment

850

Registered

2004-07-28

Start date

2004-03-02

Completion date

2012-05-28

Last updated

2026-02-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Radiotherapy is an effective treatment for people with cancer that has spread to their bones and is causing problems. Sometimes, a second course of radiation is required. This international randomised trial will determine if it is better for a second course of radiation to be done as one large treatment, or as several smaller treatments.

Interventions

Arm 2: Multiple fractionation (20 Gy, 5 fractions - 4Gy x 5 daily fractions, eight fractions (for spine and/or whole pelvis only))

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Open (masking not used)

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

1. Patient must have histologically or cytologically proven malignancy. Histological diagnosis may be established from needle biopsy, bone marrow biopsy, cytology, or a surgical biopsy or resection. All malignant histologies/cytologies are eligible. 2. Plain radigraphs, radionuclide bone scans, CT scans and/or magnetic resonance imaging confirm the presence of bone metastatses corresponding to clinically painful area.

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. The treatment area has received prior palliative surgery.4. There is planned surgical intervention on the treated bone.

Outcome results