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Intracavitary Carrier-embedded Cs131 Brachytherapy for Recurrent Brain Metastases: a Randomized Phase II Study

Primary Purpose

Recurrent Brain Metastases

Status

Recruiting

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

Craniotomy

Cesium-131 brachytherapy

About this trial

This is an interventional treatment trial for Recurrent Brain Metastases focused on measuring Cs-131 Brachytherapy, Brain Metastasis, 20-542

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Adult patients ≥ 18 years of age who are capable of giving consent
Undergoing elective craniotomy for resection of a previously-irradiated brain metastasis with suspicion for viable disease at the time of consent, and anticipated achievement of gross-total or near-total (>/=95%) resection
Karnofsky Performance Status score (KPS) of ≥70
Ability to undergo brain MRI with gadolinium

Exclusion Criteria:

Unable to tolerate MRI or CT imaging
Pregnancy (patients must have a negative pregnancy test within 30 days of the operation)
Women must agree to not breastfeed for at least 12 weeks after the procedure (lactating and discarding in that interval allowable)
Diagnosis of leptomeningeal carcinomatosis or >5 additional active or untreated CNS lesions for a total of >6 active lesions
Prior irradiation (EQD2) in excess of 100 Gy to site of implant, using an α/β of 2
Apposition of tumor margin to brainstem or optic apparatus
Previous infection within the operative field, current active systemic infection requiring systemic therapy, or immunodeficiency
Urgent surgery required prior to availability of brachytherapy

Intraoperative Exclusion Criterion:

Patients will be excluded if intraoperative pathology is not consistent with >/=5% viable metastatic disease.

Sites / Locations

Henry Ford Hospital
University of Minnesota
Memorial Sloan Kettering at Basking Ridge (Consent Only)Recruiting
Memorial Sloan Kettering Monmouth (Consent Only)Recruiting
Memorial Sloan Kettering Commack (Consent Only)Recruiting
Memorial Sloan Kettering Cancer CenterRecruiting
Memorial Sloan Kettering Nassau (Limited Protocol Activities)Recruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Resection without brachytherapy

Resection plus brachytherapy

Arm Description

Patients will undergo craniotomy.

Patients will undergo craniotomy and patients in the treatment arm will undergo implantation of Cesium 131 brachytherapy in coordination with the radiation oncologist.

Outcomes

Primary Outcome Measures

freedom from local progression

With a contrast enhanced brain MRI scan. Treatment response will be determined based on the Response Assessment in Neuro-Oncology Brain Metastases (RANO-BM) criteria.

Secondary Outcome Measures

wound complications

Physical examination including wound examination will be performed, and wound complications (including dehiscence, superficial/deep infection, CSF leak) will be recorded by the evaluating clinicians.

Full Information

NCT ID

NCT04690348

First Posted

December 28, 2020

Last Updated

March 30, 2023

Sponsor

Memorial Sloan Kettering Cancer Center

Collaborators

GT Medical Technologies, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT04690348

Brief Title

Intracavitary Carrier-embedded Cs131 Brachytherapy for Recurrent Brain Metastases: a Randomized Phase II Study

Official Title

Intracavitary Carrier-embedded Cs131 Brachytherapy for Recurrent Brain Metastases: a Randomized Phase II Study

Study Type

Interventional

2. Study Status

Record Verification Date

March 2023

Overall Recruitment Status

Recruiting

Study Start Date

December 24, 2020 (Actual)

Primary Completion Date

December 2023 (Anticipated)

Study Completion Date

December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Memorial Sloan Kettering Cancer Center

Collaborators

GT Medical Technologies, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Yes

5. Study Description

Brief Summary

The purpose of this study is to see if Cs-131 brachytherapy is effective in people with recurrent brain cancer who are scheduled to have brain surgery for removal of their tumor(s). The researchers would like to see whether Cs-131 prevents brain tumors from growing back after surgery.The researchers will compare Cs-131 brachytherapy (which occurs during brain surgery) with the usual approach of brain surgery without brachytherapy. The researchers will compare both the effectiveness and safety of the two approaches.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Recurrent Brain Metastases

Keywords

Cs-131 Brachytherapy, Brain Metastasis, 20-542

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Model Description

Prospective randomized phase II multicenter trial.

Masking

Participant

Masking Description

Patient will be blinded to their treatment until postoperatively.

Allocation

Randomized

Enrollment

76 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Resection without brachytherapy

Arm Type

Active Comparator

Arm Description

Patients will undergo craniotomy.

Arm Title

Resection plus brachytherapy

Arm Type

Experimental

Arm Description

Patients will undergo craniotomy and patients in the treatment arm will undergo implantation of Cesium 131 brachytherapy in coordination with the radiation oncologist.

Intervention Type

Procedure

Intervention Name(s)

Craniotomy

Intervention Description

Craniotomy

Intervention Type

Radiation

Intervention Name(s)

Cesium-131 brachytherapy

Intervention Description

Intracavitary Cesium-131 brachytherapy

Primary Outcome Measure Information:

Title

freedom from local progression

Description

With a contrast enhanced brain MRI scan. Treatment response will be determined based on the Response Assessment in Neuro-Oncology Brain Metastases (RANO-BM) criteria.

Time Frame

9 months following surgery

Secondary Outcome Measure Information:

Title

wound complications

Description

Physical examination including wound examination will be performed, and wound complications (including dehiscence, superficial/deep infection, CSF leak) will be recorded by the evaluating clinicians.

Time Frame

3 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Adult patients ≥ 18 years of age who are capable of giving consent Undergoing elective craniotomy for resection of a previously-irradiated brain metastasis with suspicion for viable disease at the time of consent, and anticipated achievement of gross-total or near-total (>/=95%) resection Karnofsky Performance Status score (KPS) of ≥70 Ability to undergo brain MRI with gadolinium Exclusion Criteria: Unable to tolerate MRI or CT imaging Pregnancy (patients must have a negative pregnancy test within 30 days of the operation) Women must agree to not breastfeed for at least 12 weeks after the procedure (lactating and discarding in that interval allowable) Diagnosis of leptomeningeal carcinomatosis or >5 additional active or untreated CNS lesions for a total of >6 active lesions Prior irradiation (EQD2) in excess of 100 Gy to site of implant, using an α/β of 2 Apposition of tumor margin to brainstem or optic apparatus Previous infection within the operative field, current active systemic infection requiring systemic therapy, or immunodeficiency Urgent surgery required prior to availability of brachytherapy Intraoperative Exclusion Criterion: Patients will be excluded if intraoperative pathology is not consistent with >/=5% viable metastatic disease.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Nelson Moss, MD

Phone

212-639-7075

mossn@mskcc.org

First Name & Middle Initial & Last Name or Official Title & Degree

Brandon Imber, MD

Phone

631-212-6346

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Nelson Moss, MD

Organizational Affiliation

Memorial Sloan Kettering Cancer Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

Henry Ford Hospital

City

Detroit

State/Province

Michigan

ZIP/Postal Code

48202

Country

United States

Individual Site Status

Not yet recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Adam Robin, MD

Phone

800-436-7936

Facility Name

University of Minnesota

City

Minneapolis

State/Province

Minnesota

ZIP/Postal Code

55455

Country

United States

Individual Site Status

Not yet recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Clark Chen, MD, PhD

Phone

612-624-6666

Facility Name

Memorial Sloan Kettering at Basking Ridge (Consent Only)

City

Basking Ridge

State/Province

New Jersey

ZIP/Postal Code

07920

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Nelson Moss, MD

Phone

212-639-7075

Facility Name

Memorial Sloan Kettering Monmouth (Consent Only)

City

Middletown

State/Province

New Jersey

ZIP/Postal Code

07748

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Nelson Moss, MD

Phone

212-639-7075

Facility Name

Memorial Sloan Kettering Commack (Consent Only)

City

Commack

State/Province

New York

ZIP/Postal Code

11725

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Nelson Moss, MD

Phone

212-639-7075

Facility Name

Memorial Sloan Kettering Cancer Center

City

New York

State/Province

New York

ZIP/Postal Code

10065

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Nelson Moss, MD

Phone

212-639-7075

First Name & Middle Initial & Last Name & Degree

Brandon Imber, MD

Phone

631-212-6346

First Name & Middle Initial & Last Name & Degree

Nelson Moss, MD

Facility Name

Memorial Sloan Kettering Nassau (Limited Protocol Activities)

City

Uniondale

State/Province

New York

ZIP/Postal Code

11553

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Nelson Moss, MD

Phone

212-639-7075

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.

Links:

URL

http://www.mskcc.org/mskcc/html/44.cfm

Description

Memorial Sloan Kettering Cancer Center

Learn more about this trial

Intracavitary Carrier-embedded Cs131 Brachytherapy for Recurrent Brain Metastases: a Randomized Phase II Study

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