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RAD 1002: Phase I Dose Escalation/De-escalation Study of Pre-operative Stereotactic Radiosurgery for Brain Metastases


N/A
19 Years
N/A
Open (Enrolling)
Both
Brain Metastases

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Trial Information

RAD 1002: Phase I Dose Escalation/De-escalation Study of Pre-operative Stereotactic Radiosurgery for Brain Metastases


Inclusion Criteria:



- All subjects must have history of histologically confirmed malignancy. Brain biopsy
is not required unless diagnosis is judged to be in doubt by the treating physician.

- Newly diagnosed brain metastases (four or fewer by post-contrast MRI obtained within
six weeks of study entry)

- At least one brain metastasis (index tumor) must be within 2-6 cm in maximum diameter
and deemed appropriate for surgical resection by the treating neurosurgeon.

- Karnofsky performance status (KPS) of greater than or equal to 60 (Appendix B)

- Age greater than 19

- Life expectancy greater than 12 weeks

- Subjects given written informed consent

Exclusion Criteria:

- Patients with small cell lung cancer and lymphoma are ineligible.

- More than four metastases by baseline post-contrast MRI

- Prior whole brain radiation therapy

- Insufficient recovery from all active toxicities of prior therapies

- Subjects who are deemed to be poor surgical risks by the treating neurosurgeon
because of medical comorbidities

- Pregnant or nursing women

- Women of childbearing potential who are not using an effective method of
contraception are excluded. Women of childbearing potential must have a negative
urine or serum pregnancy test within 24 hours prior to administration of SRS.

Type of Study:

Observational

Study Design:

Observational Model: Cohort, Time Perspective: Prospective

Outcome Measure:

to investigate the maximum tolerated dose (MTD) of preoperative stereotactic radiosurgery (SRS) for brain metastasis

Outcome Time Frame:

one year

Safety Issue:

Yes

Authority:

United States: Food and Drug Administration

Study ID:

F100528006

NCT ID:

NCT01252797

Start Date:

October 2010

Completion Date:

December 2013

Related Keywords:

  • Brain Metastases
  • brain metastases
  • Neoplasm Metastasis
  • Neoplasms, Second Primary
  • Brain Neoplasms

Name

Location

Hazelrig-Salter Radiation Oncology Center/University of Alabama at BirminghamBirmingham, Alabama  35233