Completed

Pilot Study of Adjuvant Fractionated Stereotactic Radiotherapy Following Surgical Removal of Cerebral Metastases

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What is being tested

surgical procedure

+ radiation therapy

+ stereotactic radiosurgery

ProcedureRadiation
Who is being recruted

Brain Diseases+9

+ Central Nervous System Diseases

+ Neoplasms

Over 18 Years
+15 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Interventional
Study Start: March 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: March 1, 1997

Actual date on which the first participant was enrolled.

OBJECTIVES: I. Assess the safety and tolerability of focal stereotactic radiotherapy to the surgical bed following excision of cerebral metastases, as an alternative to whole brain irradiation. II. Measure the local relapse rate at the surgical site after surgery and stereotactic radiotherapy in patients with cerebral metastases. III. Measure the regional relapse rate, in the brain but away from the treated site, following treatment in these patients. OUTLINE: All patients undergo surgical removal of their cerebral metastases followed by adjuvant fractionated stereotactic radiotherapy daily for 5 days. Patients are given up to 5 weeks following surgery to recover and reach the required performance status. Radiotherapy must commence within 6 weeks of surgery. Patients are followed at 2 weeks after treatment, monthly for 6 months, every 3 months for the next 18 months, every 6 months for the next year, and then annually for years 3-5. PROJECTED ACCRUAL: There will be 20-40 patients accrued into this study.

NCT00003320
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

20 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

10 inclusion criteria required to participate
Age: 18 and over

Gross resection at operation as documented in operation note and postoperative MRI Patients must have current surgical sites that have not been previously irradiated

Histologically confirmed cerebral metastases post surgical resection

Karnofsky 60-100%

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5 exclusion criteria prevent from participating
allergy to iodine or contrast media

concurrent chemotherapy

pregnant

prior whole brain irradiation or focal irradiation to current sites of disease

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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