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

• Sponsor: Maria Sklodowska-Curie National Research Institute of Oncology (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT01535209
• Collaborator: Lower Silesian Oncology Center (Other), Copernicus Memorial Hospital (Other), Prof. Franciszek Lukaszczyk Memorial Oncology Center (Other)
• Enrollment: 100
• Location: 1
• Arms: 2
• Duration (Months): 35
• Patients Per Site Per Month: 2.9

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Brain Metastases	Radiation: stereotactic body radiotherapy (SBRT); Radiation: Whole-Brain Radiotherapy (WBRT)	Phase 3

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.

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 100 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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 Start Date: Jan 1, 2012
• Anticipated Primary Completion Date: Dec 1, 2014
• Anticipated Study Completion Date: Dec 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Experimental: SBRT to resection cavity 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	Radiation: stereotactic body radiotherapy (SBRT); 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; Other Names: stereotactic body radiotherapy
Active Comparator: WBRT 30Gy in 10 fractions over 12 days to whole brain	Radiation: Whole-Brain Radiotherapy (WBRT); 10 x 3 Gy to whole brain; Other Names: whole brain irradiation adjuvant cranial irradiation

Outcome Measures

Primary Outcome Measures

1. Failure-free survival [5 months after radiotherapy]

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

Secondary Outcome Measures

1. Overall survival [2 years]

2. Quality of life assessment [2 years]

3. Time to distant intracranial progression [2 years]

4. Time to local progression [2 years]

   Time to progression in the irradiated cavity

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	M.Sklodowska-Curie Memorial Cancer Centre	Warsaw		Poland	02-781

Sponsors and Collaborators

• Maria Sklodowska-Curie National Research Institute of Oncology
• Lower Silesian Oncology Center
• Copernicus Memorial Hospital
• Prof. Franciszek Lukaszczyk Memorial Oncology Center

Investigators

• Principal Investigator: Lucyna Kepka, Prof., M.Sklodowska-Curie Memorial Cancer Centre, Warsaw, Poland

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Maria Sklodowska-Curie National Research Institute of Oncology
• ClinicalTrials.gov Identifier: NCT01535209
• Other Study ID Numbers: CAVITY
• First Posted: Feb 17, 2012
• Last Update Posted: Feb 17, 2012
• Last Verified: Feb 1, 2012

• Keywords provided by Maria Sklodowska-Curie National Research Institute of Oncology: Stereotactic radiotherapy; Whole-brain radiotherapy; Resection cavity
• Additional relevant MeSH terms: Neoplasm Metastasis; Brain Neoplasms

Study Results

No Results Posted as of Feb 17, 2012