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

NCT01252797 | Completed Phase 1 DMC FDA Device

• 1 other identifier: F100528006
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Brain Metastases

Keywords

brain metastases

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Acute Toxicity with preoperative stereotactic radiosurgery (SRS)

  6 months

• Late Toxicity with preoperative stereotactic radiosurgery (SRS)

  1 year

• Rates of Local Control

  2 years

• Rates of Leptomeningeal Dissemination

  2 years

Study Arms (2)

Stereotactic Radiosurgery (15 Gy)

ACTIVE COMPARATOR

Group A: If the tumor which will be surgically removed is at least 2 cm and up to 4 cm in maximum diameter, then this group will receive Dose Level II (15 Gy) of radiation: stereotactic radiosurgery (SRS) followed by surgery to remove the tumor.

Radiation: Stereotactic Radiosurgery (15 Gy)

Stereotactic Radiosurgery (12Gy)

EXPERIMENTAL

Group B: If the tumor which will be surgically removed is larger than 4 cm and up to 6 cm in diameter, then this group will receive Dose Level I (12 Gy) of radiation: stereotactic radiosurgery (SRS) followed by surgery to remove the tumor.

Radiation: Stereotactic Radiosurgery (12 Gy)

Interventions

Stereotactic Radiosurgery (15 Gy) RADIATION

Group A will start at dose level II: 15 Gy Group B will start at dose level I: 12 Gy

Stereotactic Radiosurgery (15 Gy)

Stereotactic Radiosurgery (12 Gy) RADIATION

Group B will start at Dose Level I: 12 Gy

Stereotactic Radiosurgery (12Gy)

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Alabama at Birmingham: lead

Study Sites (1)

Hazelrig-Salter Radiation Oncology Center/University of Alabama at Birmingham

Birmingham, Alabama, 35233, United States

Location

MeSH Terms

Conditions

Brain Neoplasms

Interventions

Radiosurgery

Condition Hierarchy (Ancestors)

Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Radiotherapy; Therapeutics; Stereotaxic Techniques; Neurosurgical Procedures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• John B. Fiveash, MD

  Hazelrig-Salter Radiation Oncology Center (HSROC)/ University of Alabama at Birmingham (UAB)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor and Vice Chair, University of Alabama at Birmingham Department of Radiation Oncology

Study Record Dates

• First Submitted: November 22, 2010
• First Posted: December 3, 2010
• Study Start: October 1, 2010
• Primary Completion: November 1, 2016
• Study Completion: April 1, 2018
• Last Updated: May 14, 2018

Record last verified: 2018-05

Locations

US (1)