A Phase II Study Analyzing Pre-operative Stereotactic Radiosurgery Followed by Resection for Patients With 1 - 4 Brain Metastases

Pre-operative Stereotactic Radiosurgery Followed by Resection for Patients With Brain Metastases



Sponsors

Lead Sponsor



Source

Indiana University

Oversight Info

Has Dmc

Yes

Is Fda Regulated Drug

No

Is Fda Regulated Device

Yes

Is Unapproved Device

No

Is Ppsd

No

Is Us Export

No


Brief Summary

This is a prospective, single arm, phase II trial to determine the local control at 6 months
utilizing pre-operative stereotactic radiosurgery followed by surgery within 1 - 3 days in
subjects with a diagnosis of 1-4 brain metastases and with an indication for surgical
resection of at least one brain metastasis at the discretion of a neurosurgeon.

Detailed Description

Primary Objective To evaluate 6 month in-brain local control utilizing pre-operative
stereotactic radiosurgery followed by surgical resection for brain metastases.

Secondary Objectives

- Overall survival

- Distant in-brain progression

- Rate of leptomeningeal spread

- Rate of radiation necrosis

Overall Status

Not yet recruiting

Start Date

2018-05-01

Completion Date

2021-02-28

Primary Completion Date

2021-02-28

Phase

Phase 2

Study Type

Interventional

Primary Outcome

Measure

Time Frame

Rate of local control of any new, recurrent, or progressing tumors within the planning target volume
6 months

Secondary Outcome

Measure

Time Frame

Rate of overall survival
6 months, 1 year, and 2 years
Rate of in-brain progression free survival
6 months, 1 year, and 2 years
Proportion of patients with distant in-brain failure (any new parenchymal lesion outside of the planning target volume)
2 years
Proportion of patients with radiation necrosis (radiographic or biopsy-positive diagnosis of radiation necrosis)
2 years
Proportion of patients with leptomeningeal spread (radiographic or CSF diagnosis of leptomeningeal disease)
2 years

Enrollment

44

Condition


Intervention

Intervention Type

Procedure

Intervention Name


Description

Stereotactic radiosurgery will be delivered on all patients utilizing gamma knife technique based on tumor diameter with the exception that the largest lesion diameter to be treated with 15 Gy will be 5 cm. All apparent, previously untreated brain metastases will be treated with radiosurgery at this time. Radiosurgery will be performed 1-3 days prior to surgical resection.

Arm Group Label

Arm 1


Eligibility

Criteria

Inclusion Criteria

1. Radiographically confirmed solid tumor brain metastases

2. Criteria for surgical resection of at least one metastasis per neurosurgeon discretion

3. A diagnostic MRI Brain or CT Head demonstrating the presence of 1-4 solid tumor brain
metastases and lesion to be resected no more than 5 cm in any direction, performed
within 30 days prior to stereotactic radiosurgery. If multiple lesions are present,
then the total brain metastases volume can be no more than 30 cm3 excluding the lesion
to be resected.

4. For known primary, ds-GPA estimated median survival no less than 6 months

5. For unknown primary, GPA estimated median survival no less than 6 months

6. Surgical candidate per neurosurgeon discretion

7. Surgical resection able to be performed within 1 - 3 days after radiosurgery

8. Stereotactic radiosurgery candidate per radiation oncologist

9. ≥ 18 years old at the time of informed consent

10. Ability to provide written informed consent and HIPAA authorization

11. Platelet count > 100 k/cumm, Hgb > 7.5 gm/dL, INR < 1.3, ANC > 1.5 k/cumm

12. Patients currently on cytotoxic chemotherapy or immunotherapy are eligible, not
including anti-VEGF therapy

Exclusion Criteria

1. Patients who received anti-VEGF therapy within 6 weeks prior to enrollment, as there
is increased risk of fatal brain hemorrhage with surgical resection

2. Major medical illnesses or psychiatric impairments, which in the investigator's
opinion will prevent administration or completion of the protocol therapy and/or
interfere with follow-up

3. Patients with more than 4 brain metastases on MRI Brain or CT Head

4. Lesion to be resected is more than 5 cm

5. Total volume of metastatic disease more than 30 cm3 excluding lesion to be resected

6. Patients with leptomeningeal metastases documented by MRI or CSF evaluation

7. Previous whole brain radiation therapy

8. Previous radiation therapy to lesion to be resected

9. Planned adjuvant focal therapy including additional radiation therapy to the brain

10. Not a surgical candidate per neurosurgeon's discretion

11. Not a radiosurgical candidate per radiation oncologist's discretion

12. Surgery unable to be performed between 1 - 3 days after radiosurgery

13. Women who are pregnant or nursing are not eligible as treatment involves unforeseeable
risks to the fetus or child

14. Patients who have a known primary and have an estimated median survival less than 6
months per ds-GPA

15. Patients who have an unknown primary and have an estimated median survival less than 6
months per GPA

Gender

All

Minimum Age

18 Years

Maximum Age

N/A

Healthy Volunteers

No


Overall Official

Last Name

Role

Affiliation

Gordon A. Watson, MD, PhD
Principal Investigator
Indiana University School of Medicine

Overall Contact

Last Name

Amy Miller

Phone

317-278-7614

Email



Location

Facility

Status

Contact

Investigator

Indiana University Health Hospital
Indianapolis Indiana 46202 United States
Not yet recruiting
Last Name: Amy Miller
Phone: 317-278-7614
Email: [email protected]
Last Name: Gordon A. Watson, MD, PhD
Role: Principal Investigator
Indiana University Health Methodist Hospital
Indianapolis Indiana 46202 United States
Not yet recruiting
Last Name: Kathy Lauer
Phone: 317-962-3172
Email: [email protected]
Last Name: Gordon A. Watson, MD, PhD
Role: Principal Investigator
Indiana University Melvin and Bren Simon Cancer Center
Indianapolis Indiana 46202 United States
Not yet recruiting
Last Name: Amy Miller
Phone: 317-278-7614
Email: [email protected]
Last Name: Gordon A. Watson, MD, PhD
Role: Principal Investigator

Location Countries

Country

United States


Verification Date

2018-03-01

Lastchanged Date

2018-03-21

Firstreceived Date

2018-01-08

Responsible Party

Responsible Party Type

Principal Investigator

Investigator Affiliation

Indiana University

Investigator Full Name

Gordon A Watson

Investigator Title

Associate Professor of Clinical Radiation Oncology


Has Expanded Access

No

Condition Browse


Secondary Id

1707314702

Number Of Arms

1

Arm Group

Arm Group Label

Arm 1

Arm Group Type

Experimental

Description

This is a single arm study so this arm will include all eligible subjects. All subjects will have radiosurgery 1-3 days prior to surgical resection.


Firstreceived Results Date

N/A

Firstreceived Results Disposition Date

N/A

Study Design Info

Intervention Model

Single Group Assignment

Primary Purpose

Treatment

Masking

None (Open Label)


Study First Submitted

January 8, 2018

Study First Submitted Qc

January 8, 2018

Study First Posted

January 12, 2018

Last Update Submitted

March 21, 2018

Last Update Submitted Qc

March 21, 2018

Last Update Posted

March 22, 2018


ClinicalTrials.gov processed this data on March 22, 2018

Conditions

Conditions usually refer to a disease, disorder, syndrome, illness, or injury. In ClinicalTrials.gov, conditions include any health issue worth studying, such as lifespan, quality of life, health risks, etc.
Interventions

Interventions refer to the drug, vaccine, procedure, device, or other potential treatment being studied. Interventions can also include less intrusive possibilities such as surveys, education, and interviews.
Study Phase

Most clinical trials are designated as phase 1, 2, 3, or 4, based on the type of questions that study is seeking to answer:

In Phase 1 (Phase I) clinical trials, researchers test a new drug or treatment in a small group of people (20-80) for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.

In Phase 2 (Phase II) clinical trials, the study drug or treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety.

In Phase 3 (Phase III) clinical trials, the study drug or treatment is given to large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.

In Phase 4 (Phase IV) clinical trials, post marketing studies delineate additional information including the drug's risks, benefits, and optimal use.

These phases are defined by the Food and Drug Administration in the Code of Federal Regulations.



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