A Trial Comparing Radiosurgery With Surgery for Solitary Brain Metastases

NCT00124761 | Completed Phase 3

• 1 other identifier: 021108
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

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.

Conditions

Neoplasm Metastasis; Brain Neoplasm

Keywords

Radiosurgery; Brain metastases; Whole Brain Radiotherapy; Neurosurgery; Solitary Brain Metastases; Adult Tumours Metastatic to Brain

Outcome Measures

Primary Outcomes (1)

• Overall survival and Quality of life

  Until death or study completion

Secondary Outcomes (3)

• Local and distant recurrence

  Until death or study completion

• Failure free survival

  Until death or study completion

• Acute and late toxicities

  Acute toxicities 6 weeks post RT and late toxicities until death

Study Arms (2)

Surgery + Whole Brain Radiotherapy

OTHER

Procedure: Surgery + WBRT

RadioSurgery + Whole Brain Radiotherapy

EXPERIMENTAL

Radiation: Radiosurgery + WBRT

Interventions

Surgery + WBRT PROCEDURE

Surgery - complete excision of Solitary Brain Metastasis with 30 Gy in 10 fractions over 2 2 1/2 weeks

Also known as: S + WBRT

Surgery + Whole Brain Radiotherapy

Radiosurgery + WBRT RADIATION

Radiosurgery - Marginal dose based on maximum tumour diameter

Also known as: RS + WBRT

RadioSurgery + Whole Brain Radiotherapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Single presumed brain metastasis on contrast magnetic resonance imaging (MRI) scan within two weeks before commencement of treatment.
• Systemic cancer diagnosed histologically or cytologically synchronous with, or within 5 years of treatment of the presumed brain metastasis (other than non-melanoma skin cancer and cancer in-situ of the cervix, neither of which would be reasonably attributable as the primary site). Exception - melanoma diagnosed \> 5 years previously is allowable in view of the extremely variable natural history of melanoma.
• Age \>= 18 (no upper age limit).
• Patient must agree to adjuvant WBRT.
• RTOG RPA Class 1 or 2 (Karnofsky Performance Status \[KPS\] \>= 70 after adequate trial of corticosteroids).
• RPA Class 3 patients (KPS \< 70) eligible if it is considered that the poor performance status is due primarily to the solitary metastasis, aggressive local treatment of which may be expected to restore good performance status. This would ordinarily be associated with minimal systemic disease burden.
• Accessible for treatment and follow-up.
• Patient is infertile or is aware of the risk of becoming pregnant or fathering children and will use adequate contraception.
• Written informed consent

You may not qualify if:

• Previous history of brain metastasis(es)
• Surgery indicated to relieve life-threatening raised intracranial pressure or excision required for tissue diagnosis (no extra-cranial site to biopsy ie unknown primary). However, prior diagnostic (non-excisional) biopsy is allowable - it is acknowledged that the 50% probability of a repeat surgical procedure on subsequent randomisation would not be acceptable to many patients and clinicians.
• Surgery contraindicated by site (e.g. thalamus, brain stem) or medical co-morbidities.
• Leptomeningeal disease.
• Primary is small cell lung cancer, germ cell tumour, lymphoma, leukaemia or myeloma.
• Prior cranial RT (including RS).
• Patient is pregnant.

Sponsors & Collaborators

• Royal Adelaide Hospital: lead

Study Sites (1)

Royal Adelaide Hospital

Adelaide, South Australia, 5000, Australia

Location

Related Publications (2)

• Roos DE, Brophy BP, Zavgorodni SF, Katsilis ES. Radiosurgery for brain metastases at the Royal Adelaide Hospital: are we treating the right patients? Australas Radiol. 2002 Dec;46(4):402-8. doi: 10.1046/j.1440-1673.2002.t01-1-01094.x.

  PMID: 12452912 BACKGROUND

• Roos DE, Smith JG, Stephens SW. Radiosurgery versus surgery, both with adjuvant whole brain radiotherapy, for solitary brain metastases: a randomised controlled trial. Clin Oncol (R Coll Radiol). 2011 Nov;23(9):646-51. doi: 10.1016/j.clon.2011.04.009. Epub 2011 May 17.

  PMID: 21592754 DERIVED

MeSH Terms

Conditions

Neoplasm Metastasis; Brain Neoplasms

Interventions

Surgical Procedures, Operative; Radiosurgery

Condition Hierarchy (Ancestors)

Neoplastic Processes; Neoplasms; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Radiotherapy; Therapeutics; Stereotaxic Techniques; Neurosurgical Procedures; Investigative Techniques

Study Officials

• Daniel Roos, MD, FRANZCR

  Royal Adelaide Hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: July 27, 2005
• First Posted: July 28, 2005
• Study Start: December 1, 2002
• Primary Completion: April 1, 2009
• Study Completion: May 1, 2009
• Last Updated: September 6, 2010

Record last verified: 2010-09

Locations

AU (1)