Completed

Prognostic Factors Associated With Successful Omission of Whole Brain Radiotherapy in Patients With 4 or Less Cerebral Metastases Treated With Focal Radiation or Surgery

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What is being tested

conventional surgery

+ radiation therapy

ProcedureRadiation
Who is being recruted

Brain Diseases+9

+ Central Nervous System Diseases

+ Neoplasms

Over 18 Years
+11 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Interventional
Study Start: December 1997
See protocol details

Summary

Principal SponsorJonsson Comprehensive Cancer Center
Last updated: August 3, 2020
Sourced from a government-validated database.Claim as a partner

Study start date: December 1, 1997

Actual date on which the first participant was enrolled.

OBJECTIVES: Develop prognostic factors for patients with brain metastases treated by focal treatment without concurrent whole brain irradiation. Determine whether focal treatment without whole brain radiotherapy produces good long-term outcome in patients with four or less cerebral metastases. Assess survival, physical and cognitive functioning, and quality of life of patients treated on this protocol. OUTLINE: Quality of life is assessed using the FACT-BR scale, physical function is assessed using the FIM scale, and cognition is assessed using two brief pencil and paper tests. Patients receive focal therapy for cerebral metastases by any combination of (1) surgery plus fractionated stereotactic radiotherapy to surgical bed, or (2) single fraction stereotactic radiotherapy by linear accelerator with or without a radiation sensitizer. Patients are followed at 2 and 10 weeks, then every 3 months for 18 months, then every 6 months for 3 years, then annually. Quality of life is assessed at each followup visit. Patients suffering intracerebral relapse are offered further focal therapy if they have no more than 3 metastases, no more than 6 lesions over consecutive scans, and continue to have life expectancy of at least 3 months and Karnofsky performance status of 60-100%. Otherwise, relapsed patients are offered whole brain radiotherapy or supportive treatment with steroids, and may also receive stereotactic boost to the new lesions. Patients who have received prior whole brain irradiation will be offered entry into other protocols if eligible or supportive treatment with steroids. Patients are followed as above. PROJECTED ACCRUAL: At least 60 patients will be enrolled in this study.

NCT00003324
Principal SponsorJonsson Comprehensive Cancer Center
Last updated: August 3, 2020
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

61 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Brain DiseasesCentral Nervous System DiseasesNeoplasmsNeoplasms by SiteNeoplastic ProcessesNervous System DiseasesNervous System NeoplasmsPathologic ProcessesPathological Conditions, Signs and SymptomsCentral Nervous System NeoplasmsBrain NeoplasmsNeoplasm Metastasis

Criteria

8 inclusion criteria required to participate
18 and over

Biopsy proven cerebral metastases other than from small cell lung cancer or lymphoma

Biopsy, CT scan, or MRI proven cerebral metastases with known current or previous systemic malignancy OR

Concurrent steroids allowed

Show More Criteria

3 exclusion criteria prevent from participating
more than 2 weeks since prior focal radiation

more than 2 weeks since prior focal surgery

more than four cerebral metastases on MRI scan and suitable for focal treatment with surgery and/or stereotactic radiotherapy with a linear accelerator

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Jonsson Comprehensive Cancer Center, UCLA

Los Angeles, United StatesOpen Jonsson Comprehensive Cancer Center, UCLA in Google Maps
CompletedOne Study Center