A Trial Comparing Radiosurgery With Surgery for Solitary Brain Metastases
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00124761|
Recruitment Status : Completed
First Posted : July 28, 2005
Last Update Posted : September 6, 2010
|Condition or disease||Intervention/treatment||Phase|
|Neoplasm Metastasis Brain Neoplasm||Procedure: Surgery + WBRT Radiation: Radiosurgery + WBRT||Phase 3|
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.
- 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 S/RS 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, and/or as clinically indicated. Acute toxicity monitored by NCI Common Toxicity Criteria, late toxicity by RTOG/EORTC 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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||22 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Randomised Trial of Surgery Plus Whole Brain Radiotherapy (WBRT) Versus Radiosurgery Plus WBRT for Solitary Brain Metastases|
|Study Start Date :||December 2002|
|Primary Completion Date :||April 2009|
|Study Completion Date :||May 2009|
|Surgery + Whole Brain Radiotherapy||
Procedure: Surgery + WBRT
Surgery - complete excision of Solitary Brain Metastasis with 30 Gy in 10 fractions over 2 2 1/2 weeks
Other Name: S + WBRT
|Experimental: RadioSurgery + Whole Brain Radiotherapy||
Radiation: Radiosurgery + WBRT
Radiosurgery - Marginal dose based on maximum tumour diameter
Other Name: RS + WBRT
- Overall survival and Quality of life [ Time Frame: Until death or study completion ]
- Local and distant recurrence [ Time Frame: Until death or study completion ]
- Failure free survival [ Time Frame: Until death or study completion ]
- Acute and late toxicities [ Time Frame: Acute toxicities 6 weeks post RT and late toxicities until death ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00124761
|Australia, South Australia|
|Royal Adelaide Hospital|
|Adelaide, South Australia, Australia, 5000|
|Study Chair:||Daniel Roos, MD, FRANZCR||Royal Adelaide Hospital|