Ignite Creation Date:
2024-05-05 @ 11:46 AM
Last Modification Date:
2024-10-26 @ 9:13 AM
Study NCT ID:
NCT00124761
Status:
COMPLETED
Last Update Posted:
2010-09-06
First Post:
2005-07-27
Brief Title:
A Trial Comparing Radiosurgery With Surgery for Solitary Brain Metastases
Sponsor:
Royal Adelaide Hospital
Organization:
Royal Adelaide Hospital
Study Overview
Official Title:
A Randomised Trial of Surgery Plus Whole Brain Radiotherapy WBRT Versus Radiosurgery Plus WBRT for Solitary Brain Metastases
Status:
COMPLETED
Status Verified Date:
2010-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study examines surgery versus radiosurgery highly focussed radiation for the treatment of cancer which has spread to one spot in the brain solitary brain metastasis For these two treatment options it will compare patients survival times quality of life control rate of the brain metastases and side effects It uses the most rigorous scientific method available called randomisation which minimises biases that exist with other types of studies It will involve 30 - 40 patients
Detailed Description:
Primary objectives - to evaluate for solitary brain metastases whether both overall survival and health related quality of life HQoL in patients treated with radiosurgery RS plus whole brain radiotherapy WBRT are non-inferior to those of patients treated with surgery S plus WBRT
Secondary objectives - to compare between the two treatment arms time to local and distant brain recurrence failure free survival acute and late toxicity
Hypothesis - Patients treated with RS WBRT have neither worse survival nor worse quality of life than those treated with S WBRT
Research plan
Trial design - Single-centre prospective randomised Phase III controlled two arm non-inferiority study with the gold standard of surgery plus WBRT as the control arm Blinding to trial arm will not be feasible Stratification is by Radiation Therapy Oncology Group Recursive Partitioning Analysis RPA prognostic Class 1 vs 2 vs 3
Main eligibility criteria - single presumed metastasis on MRI brain systemic cancer diagnosed within the last 5 years considered suitable for both S and RS written informed consent
Main exclusion criteria - surgery indicated for life-threatening raised intra-cranial pressure or tissue diagnosis surgery contra-indicated by site or medical co-morbidities leptomeningeal disease primary is small cell lung cancer germ cell tumour lymphoma leukaemia or myeloma
Radiation - WBRT dose is 30 Gy in 10 fractions over 2 weeks RS dose is based on lesion size up to 4 cm 15-20 Gy
Surgery - Aim is complete excision
Treatment sequence and patient assessments - Any sequencing of SRS and WBRT is allowable as long as the brain treatment is commenced within 2 weeks after and completed within 6½ weeks after the diagnostic MRI brain Assessments at baseline during brain treatment at 2 and 3 months after commencement then 3 monthly with MRI brain at 3 and 6 months andor as clinically indicated Acute toxicity monitored by NCI Common Toxicity Criteria late toxicity by RTOGEORTC Late Radiation Morbidity Scheme HQoL assessed by EORTC QLQ-C30 and QLQ-BN20
Sample size - 30-40 patients over 5 years
Outcomes and Significance
The trial will enable Level I evidence to be applied to this common clinical problem Patients will be able to make an informed choice based upon valid survival quality of life and toxicity comparisons
Secondary objectives - to compare between the two treatment arms time to local and distant brain recurrence failure free survival acute and late toxicity
Hypothesis - Patients treated with RS WBRT have neither worse survival nor worse quality of life than those treated with S WBRT
Research plan
Trial design - Single-centre prospective randomised Phase III controlled two arm non-inferiority study with the gold standard of surgery plus WBRT as the control arm Blinding to trial arm will not be feasible Stratification is by Radiation Therapy Oncology Group Recursive Partitioning Analysis RPA prognostic Class 1 vs 2 vs 3
Main eligibility criteria - single presumed metastasis on MRI brain systemic cancer diagnosed within the last 5 years considered suitable for both S and RS written informed consent
Main exclusion criteria - surgery indicated for life-threatening raised intra-cranial pressure or tissue diagnosis surgery contra-indicated by site or medical co-morbidities leptomeningeal disease primary is small cell lung cancer germ cell tumour lymphoma leukaemia or myeloma
Radiation - WBRT dose is 30 Gy in 10 fractions over 2 weeks RS dose is based on lesion size up to 4 cm 15-20 Gy
Surgery - Aim is complete excision
Treatment sequence and patient assessments - Any sequencing of SRS and WBRT is allowable as long as the brain treatment is commenced within 2 weeks after and completed within 6½ weeks after the diagnostic MRI brain Assessments at baseline during brain treatment at 2 and 3 months after commencement then 3 monthly with MRI brain at 3 and 6 months andor as clinically indicated Acute toxicity monitored by NCI Common Toxicity Criteria late toxicity by RTOGEORTC Late Radiation Morbidity Scheme HQoL assessed by EORTC QLQ-C30 and QLQ-BN20
Sample size - 30-40 patients over 5 years
Outcomes and Significance
The trial will enable Level I evidence to be applied to this common clinical problem Patients will be able to make an informed choice based upon valid survival quality of life and toxicity comparisons
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None