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Stereotactic Radiotherapy of Resection Cavity For Single Brain Metastasis Versus Whole-Brain Radiotherapy After Resection

Primary Purpose

Brain Metastases

Status

Unknown status

Phase

Phase 3

Locations

Poland

Study Type

Interventional

Intervention

stereotactic body radiotherapy (SBRT)

Whole-Brain Radiotherapy (WBRT)

About this trial

This is an interventional treatment trial for Brain Metastases focused on measuring Stereotactic radiotherapy, Whole-brain radiotherapy, Resection cavity

Eligibility Criteria

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

Inclusion Criteria:

Patients with surgically removed histologically proven metastatic cancer
Subtotal or total resection of single brain metastasis
Presence of single brain metastasis in MRI
Karnofsky Performance Status ≥ 70
Life expectancy > 6 months (minimal extracranial disease or availability of effective oncology treatment)
No previous history of cranial irradiation
Availability of MRI
Starting radiotherapy within six weeks after neurosurgery
Negative pregnancy test for woman
Written informed consent

Exclusion Criteria:

Dementia and central nervous system diseases leading to higher risk of radiation toxicity
Contraindications for MRI and/or no patient's tolerance and acceptance of cranial MRI
Altered level of consciousness
Histologically proven metastatic small cell lung cancer

Sites / Locations

M.Sklodowska-Curie Memorial Cancer CentreRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

SBRT to resection cavity

WBRT

Arm Description

18Gy in 1 fraction for resection cavity <2cm in maximum diameter, 15Gy in 1 fraction for resection cavity 2.1-3cm in maximum diameter, 15Gy in 1 fraction or 25 Gy in 5 fractions over 5 days for resection cavity 3.1-4cm in maximum diameter, 25 Gy in 5 fractions over 5 days for resection cavity >4cm in maximum diameter

30Gy in 10 fractions over 12 days to whole brain

Outcomes

Primary Outcome Measures

Failure-free survival

Time to decrease in MRC scale by 1 point or in MMSE by 3 points or neurologic death.

Secondary Outcome Measures

Overall survival

Quality of life assessment

Time to distant intracranial progression

Time to local progression

Time to progression in the irradiated cavity

Full Information

NCT ID

NCT01535209

First Posted

February 14, 2012

Last Updated

February 16, 2012

Sponsor

Maria Sklodowska-Curie National Research Institute of Oncology

Collaborators

Lower Silesian Oncology Center, Copernicus Memorial Hospital, Prof. Franciszek Lukaszczyk Memorial Oncology Center

1. Study Identification

Unique Protocol Identification Number

NCT01535209

Brief Title

Stereotactic Radiotherapy of Resection Cavity For Single Brain Metastasis Versus Whole-Brain Radiotherapy After Resection

Official Title

Phase 3 Study of Stereotactic Radiotherapy of the Postoperative Resection Cavity Versus Whole-Brain Irradiation After Surgical Resection of Single Brain Metastasis

Study Type

Interventional

2. Study Status

Record Verification Date

February 2012

Overall Recruitment Status

Unknown status

Study Start Date

January 2012 (undefined)

Primary Completion Date

December 2014 (Anticipated)

Study Completion Date

December 2014 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Maria Sklodowska-Curie National Research Institute of Oncology

Collaborators

Lower Silesian Oncology Center, Copernicus Memorial Hospital, Prof. Franciszek Lukaszczyk Memorial Oncology Center

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

Adjuvant whole-brain radiation therapy (WBRT) after resection of single brain metastasis is considered as a standard associated with side effects leading to decreased neurocognitive function. The Investigators addressed the question whether stereotactic radiotherapy of the resection cavity impairs neurological status and/or cognitive functions in compare to adjuvant WBRT.

Detailed Description

Patients with surgically removed single brain metastasis are randomly allocated to control or experimental arm. Before treatment the MRC Neurological Status Scale is used for assessing neurological status, the EORTC QLQ-C30 and QLQ-BN20 for quality of life and Mini-Mental State Examination to assess cognitive functioning. The control group receive 30Gy in 10 fractions of 3Gy over 12 days to the whole brain. The patients in the experimental arm are treated with stereotactic radiotherapy to the resection cavity. The dose to the tumor bed is 15-18Gy in one fraction or 25Gy in 5 fractions. The study hypothesis is that the difference in the 5-months failure free survival rate isn't higher than 25% in experimental arm compared to control arm.

6. Conditions and Keywords

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

Brain Metastases

Keywords

Stereotactic radiotherapy, Whole-brain radiotherapy, Resection cavity

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

SBRT to resection cavity

Arm Type

Experimental

Arm Description

Arm Title

WBRT

Arm Type

Active Comparator

Arm Description

30Gy in 10 fractions over 12 days to whole brain

Intervention Type

Radiation

Intervention Name(s)

stereotactic body radiotherapy (SBRT)

Other Intervention Name(s)

stereotactic body radiotherapy

Intervention Description

Intervention Type

Radiation

Intervention Name(s)

Whole-Brain Radiotherapy (WBRT)

Other Intervention Name(s)

whole brain irradiation, adjuvant cranial irradiation

Intervention Description

10 x 3 Gy to whole brain

Primary Outcome Measure Information:

Title

Failure-free survival

Description

Time to decrease in MRC scale by 1 point or in MMSE by 3 points or neurologic death.

Time Frame

5 months after radiotherapy

Secondary Outcome Measure Information:

Title

Overall survival

Time Frame

2 years

Title

Quality of life assessment

Time Frame

2 years

Title

Time to distant intracranial progression

Time Frame

2 years

Title

Time to local progression

Description

Time to progression in the irradiated cavity

Time Frame

2 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Patients with surgically removed histologically proven metastatic cancer Subtotal or total resection of single brain metastasis Presence of single brain metastasis in MRI Karnofsky Performance Status ≥ 70 Life expectancy > 6 months (minimal extracranial disease or availability of effective oncology treatment) No previous history of cranial irradiation Availability of MRI Starting radiotherapy within six weeks after neurosurgery Negative pregnancy test for woman Written informed consent Exclusion Criteria: Dementia and central nervous system diseases leading to higher risk of radiation toxicity Contraindications for MRI and/or no patient's tolerance and acceptance of cranial MRI Altered level of consciousness Histologically proven metastatic small cell lung cancer

Central Contact Person:

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

Wojciech Michalski, M.S.

Phone

+48226433909

W.Michalski@coi.waw.pl

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Lucyna Kepka, Prof.

Organizational Affiliation

M.Sklodowska-Curie Memorial Cancer Centre, Warsaw, Poland

Official's Role

Principal Investigator

Facility Information:

Facility Name

M.Sklodowska-Curie Memorial Cancer Centre

City

Warsaw

ZIP/Postal Code

02-781

Country

Poland

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Lucyna Kepka, Prof.

Phone

+48226439287

lucynak@coi.waw.pl

First Name & Middle Initial & Last Name & Degree

Lucyna Kepka, Prof.

12. IPD Sharing Statement

Learn more about this trial

Stereotactic Radiotherapy of Resection Cavity For Single Brain Metastasis Versus Whole-Brain Radiotherapy After Resection

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