Dose Escalation/De-escalation Study of Pre-operative Stereotactic Radiosurgery for Brain Metastases(RAD 1002)

Brain Metastases Clinical Trial

— RAD 1002  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01252797
• Other study ID #: F100528006
• Status: Completed
• Phase: Phase 1
• Start date: October 2010
• Est. completion date: April 2018

Study information

• Verified date: May 2018
• Source: University of Alabama at Birmingham
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study will investigate the safety, tolerability, and effectiveness of changing the order of receiving radiation therapy for treating brain cancer. The investigators hope that changing the sequence of radiation therapy will lower the risk of cancer spreading throughout your spinal fluid, which covers your brain and spinal cord.

Description:

This study will attempt to determine the maximum tolerated dose of pre-operative stereotactic radiosurgery (SRS) in the treatment of brain metastases. Patients will be placed in one of two dose groups based on index tumor size, and dose will be adjusted according to presence or absence of dose limiting toxicity (DLT).

Group A: Index Tumor > 2 cm and up to 4 cm in maximum diameter Group B: Index Tumor > 4 cm and up to 6 cm in maximum diameter

Dose escalation or de-escalation will be conducted via a modified 3+3 method at the following levels. Group A will start at dose level II. Group B will start at dose level I.

Dose Level I: 12 Gy Dose Level II: 15 Gy

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: April 2018
• Est. primary completion date: November 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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

• 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.

Related Conditions & MeSH terms

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

Intervention

Radiation:
• Stereotactic Radiosurgery (15 Gy)
Group A will start at dose level II: 15 Gy Group B will start at dose level I: 12 Gy
• Stereotactic Radiosurgery (12 Gy)
Group B will start at Dose Level I: 12 Gy

Locations

Country	Name	City	State
United States	Hazelrig-Salter Radiation Oncology Center/University of Alabama at Birmingham	Birmingham	Alabama

Sponsors (1)

Lead Sponsor	Collaborator
University of Alabama at Birmingham

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	maximum tolerated dose (MTD) of preoperative stereotactic radiosurgery (SRS) for brain metastasis	The maximum tolerated dose (MTD) is defined as the highest dose of stereotactic radiosurgery delivered pre-operative at which no more than 2 out of 6 patients experience a dose limiting toxicity (DLT).	one year
Secondary	Acute Toxicity with preoperative stereotactic radiosurgery (SRS)	Any possible, probable, or definite treatment-related AE or SAE (assessed by CTCAE 4.0) occurring within six months or less from the date of stereotactic radiosurgery was received.	6 months
Secondary	Late Toxicity with preoperative stereotactic radiosurgery (SRS)	Any possible, probable, or definite treatment-related AE or SAE (assessed by CTCAE 4.0) occurring more than six months from the date of stereotactic radiosurgery was received.	1 year
Secondary	Rates of Local Control	This will be assessed by MRI Imaging obtained post-operatively at follow-up visits.	2 years
Secondary	Rates of Leptomeningeal Dissemination	Leptomeningeal Dissemination (LMD) defined as diffuse carcinomatosis and/or distant focal pachymeningeal (dural) tumor and assessed by MRI Imaging for the study period.	2 years