deltatrials
Completed NA INTERVENTIONAL NCT00003320

Radiation Therapy Following Surgery to Remove Brain Metastases

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

Sponsor: Jonsson Comprehensive Cancer Center

Updated 6 times since 2017 Last updated: Jul 30, 2020 Started: Mar 31, 1997 Primary completion: Aug 31, 2006
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

Listed as NCT00003320, this NA trial focuses on Metastatic Cancer and remains completed. Sponsored by Jonsson Comprehensive Cancer Center, it has been updated 6 times since 1997, reflecting limited change activity. This study contributes to the evolving evidence base for cancer treatment protocols.

Study Description(click to expand)

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.

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.

Status Flow

~Jan 2017 – ~Jun 2018 · 17 months · monthly snapshotCompleted~Jun 2018 – ~Sep 2020 · 27 months · monthly snapshotCompleted~Sep 2020 – ~Jan 2021 · 4 months · monthly snapshotCompleted~Jan 2021 – ~Jul 2024 · 42 months · monthly snapshotCompleted~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshotCompleted~Sep 2024 – present · 19 months · monthly snapshotCompleted

Change History

6 versions recorded
  1. Sep 2024 — Present [monthly]

    Completed NA

  2. Jul 2024 — Sep 2024 [monthly]

    Completed NA

  3. Jan 2021 — Jul 2024 [monthly]

    Completed NA

  4. Sep 2020 — Jan 2021 [monthly]

    Completed NA

  5. Jun 2018 — Sep 2020 [monthly]

    Completed NA

Show 1 earlier version
  1. Jan 2017 — Jun 2018 [monthly]

    Completed NA

    First recorded

Mar 1997

Trial started

Per CT.gov start date — pre-dates our first snapshot

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • Jonsson Comprehensive Cancer Center
Data source: Jonsson Comprehensive Cancer Center

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations