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Stereotactic Radiotherapy of Resection Cavity For Single Brain Metastasis Versus Whole-Brain Radiotherapy After Resection
The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified February 2012 by Maria Sklodowska-Curie Memorial Cancer Center, Institute of Oncology.
Recruitment status was: Recruiting
Recruitment status was: Recruiting
Sponsor:
Maria Sklodowska-Curie Memorial Cancer Center, Institute of Oncology
Collaborators:
Lower Silesian Oncology Center
Copernicus Memorial Hospital
Oncology Centre - prof. Franciszek Łukaszczyk Memorial Hospital
Information provided by (Responsible Party):
Maria Sklodowska-Curie Memorial Cancer Center, Institute of Oncology
ClinicalTrials.gov Identifier:
NCT01535209
First received: February 14, 2012
Last updated: February 16, 2012
Last verified: February 2012
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Purpose
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 | Intervention | Phase |
|---|---|---|
| Brain Metastases | Radiation: stereotactic body radiotherapy (SBRT) Radiation: Whole-Brain Radiotherapy (WBRT) | Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: 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 |
Further study details as provided by Maria Sklodowska-Curie Memorial Cancer Center, Institute of Oncology:
Primary Outcome Measures:
- 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.
Secondary Outcome Measures:
- 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
| Estimated Enrollment: | 100 |
| Study Start Date: | January 2012 |
| Estimated Study Completion Date: | December 2014 |
| Estimated Primary Completion Date: | December 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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:
|
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.
Eligibility| Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01535209
Please refer to this study by its ClinicalTrials.gov identifier: NCT01535209
Contacts
| Contact: Wojciech Michalski, M.S. | +48226433909 | W.Michalski@coi.waw.pl |
Locations
| 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. | |
Sponsors and Collaborators
Maria Sklodowska-Curie Memorial Cancer Center, Institute of Oncology
Lower Silesian Oncology Center
Copernicus Memorial Hospital
Oncology Centre - prof. Franciszek Łukaszczyk Memorial Hospital
Investigators
| Principal Investigator: | Lucyna Kepka, Prof. | M.Sklodowska-Curie Memorial Cancer Centre, Warsaw, Poland |
More Information
| Responsible Party: | Maria Sklodowska-Curie Memorial Cancer Center, Institute of Oncology |
| ClinicalTrials.gov Identifier: | NCT01535209 History of Changes |
| Other Study ID Numbers: |
CAVITY |
| Study First Received: | February 14, 2012 |
| Last Updated: | February 16, 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 |
ClinicalTrials.gov processed this record on June 23, 2017