Stereotactic Radiotherapy of Resection Cavity For Single Brain Metastasis Versus Whole-Brain Radiotherapy After Resection
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT01535209 |
Recruitment Status
: Unknown
Verified February 2012 by Maria Sklodowska-Curie Memorial Cancer Center, Institute of Oncology.
Recruitment status was: Recruiting
First Posted
: February 17, 2012
Last Update Posted
: February 17, 2012
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Brain Metastases | Radiation: stereotactic body radiotherapy (SBRT) Radiation: Whole-Brain Radiotherapy (WBRT) | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Estimated 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 : | January 2012 |
Estimated Primary Completion Date : | December 2014 |
Estimated Study Completion Date : | December 2014 |
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 Name: 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:
|
- Failure-free survival [ Time Frame: 5 months after radiotherapy ]Time to decrease in MRC scale by 1 point or in MMSE by 3 points or neurologic death.
- Overall survival [ Time Frame: 2 years ]
- Quality of life assessment [ Time Frame: 2 years ]
- Time to distant intracranial progression [ Time Frame: 2 years ]
- Time to local progression [ Time Frame: 2 years ]Time to progression in the irradiated cavity

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01535209
Contact: Wojciech Michalski, M.S. | +48226433909 | W.Michalski@coi.waw.pl |
Poland | |
M.Sklodowska-Curie Memorial Cancer Centre | Recruiting |
Warsaw, Poland, 02-781 | |
Contact: Lucyna Kepka, Prof. +48226439287 lucynak@coi.waw.pl | |
Principal Investigator: Lucyna Kepka, Prof. |
Principal Investigator: | Lucyna Kepka, Prof. | M.Sklodowska-Curie Memorial Cancer Centre, Warsaw, Poland |
Responsible Party: | Maria Sklodowska-Curie Memorial Cancer Center, Institute of Oncology |
ClinicalTrials.gov Identifier: | NCT01535209 History of Changes |
Other Study ID Numbers: |
CAVITY |
First Posted: | February 17, 2012 Key Record Dates |
Last Update Posted: | February 17, 2012 |
Last Verified: | February 2012 |
Keywords provided by Maria Sklodowska-Curie Memorial Cancer Center, Institute of Oncology:
Stereotactic radiotherapy Whole-brain radiotherapy Resection cavity |
Additional relevant MeSH terms:
Neoplasm Metastasis Brain Neoplasms Neoplastic Processes Neoplasms Pathologic Processes Central Nervous System Neoplasms |
Nervous System Neoplasms Neoplasms by Site Brain Diseases Central Nervous System Diseases Nervous System Diseases |