A RAndomized trial comparing COnventional with STereotactic radiotherapy for pain reduction and quality of life in spinal metastases "RACOST"

A RAndomized trial comparing COnventional with STereotactic radiotherapy for pain reduction and quality of life in spinal metastases "RACOST" - RACOST

Status

Active, not recruiting

Phases

Phase 3

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON41242

Enrollment

386

Registered

2014-12-18

Start date

2015-06-22

Completion date

Unknown

Last updated

2024-04-23

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

Conditions

spinal metastases

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: • Histologically proven solid tumor with radiological diagnosis of spinal metastases • Pain score minimum 2 on 11-point scale (0=no pain to 10= worst imaginable pain) • Maximum of 2 consecutive or noncontiguous spinal vertebra involved by tumor • Gross tumor optimally >3mm from the spinal cord on MRI • Karnofsky performance status >= 60 • WHO >= 2 • Life expectancy > 6 weeks

Exclusion criteria

Exclusion criteria: • History of previous radiotherapy to the spine at the current level of interest or overlapping location • Chemotherapy or targeted systemic therapy within 14 days of radiotherapy • Spinal instability or neurological deficit resulting from bony compression of neural structures • Pathologic fracture or impending fracture needing surgical fixation • Prior surgery to the spine at the current level of interest or overlapping location • More than 25% spinal canal compromise

Design outcomes

Primary

Measure	Time frame
Pain reduction	—

Secondary

Measure	Time frame
• Comparison of the time to response between the randomization arms • Comparison of the time to progression between the randomization arms • Comparison of the quality of life between the randomization arms • Comparison of the toxicity according to CTC-AE 4 criteria between the randomization arms • Comparison of the incidence of radiation induced fracture between the randomization arms • Comparison of the difference in primary endpoint between patients with oligometastases and other patients • Comparison of the difference in primary endpoint between patients surviving more or less than 12 weeks	—

Measure

Time frame

• Comparison of the time to response between the randomization arms • Comparison of the time to progression between the randomization arms • Comparison of the quality of life between the randomization arms • Comparison of the toxicity according to CTC-AE 4 criteria between the randomization arms • Comparison of the incidence of radiation induced fracture between the randomization arms • Comparison of the difference in primary endpoint between patients with oligometastases and other patients • Comparison of the difference in primary endpoint between patients surviving more or less than 12 weeks

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Countries

Netherlands

Outcome results