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

Brain Metastases Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01535209
• Other study ID #: CAVITY
• Status: Recruiting
• Phase: Phase 3
• First received: February 14, 2012
• Last updated: February 16, 2012
• Start date: January 2012
• Est. completion date: December 2014

Study information

• Verified date: February 2012
• Source: Maria Sklodowska-Curie Memorial Cancer Center, Institute of Oncology
• Contact: Wojciech Michalski, M.S.
• Phone: +48226433909
• Email: W.Michalski[@]coi.waw.pl
• Is FDA regulated: No
• Health authority: Poland: Ministry of Science and Higher Education
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 2014
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Brain Metastases
• Brain Neoplasms
• Neoplasm Metastasis

Intervention

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
• Whole-Brain Radiotherapy (WBRT)
10 x 3 Gy to whole brain

Locations

Country	Name	City	State
Poland	M.Sklodowska-Curie Memorial Cancer Centre	Warsaw

Sponsors (4)

Lead Sponsor	Collaborator
Maria Sklodowska-Curie Memorial Cancer Center, Institute of Oncology	Copernicus Memorial Hospital, Lower Silesian Oncology Center, Oncology Centre - prof. Franciszek Lukaszczyk Memorial Hospital

Country where clinical trial is conducted

Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Failure-free survival	Time to decrease in MRC scale by 1 point or in MMSE by 3 points or neurologic death.	5 months after radiotherapy	No
Secondary	Overall survival		2 years	No
Secondary	Quality of life assessment		2 years	No
Secondary	Time to distant intracranial progression		2 years	No
Secondary	Time to local progression	Time to progression in the irradiated cavity	2 years	No