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


Phase 3
18 Years
N/A
Open (Enrolling)
Both
Brain Metastases

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Trial Information

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


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.


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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Failure-free survival

Outcome Description:

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

Outcome Time Frame:

5 months after radiotherapy

Safety Issue:

No

Principal Investigator

Lucyna Kepka, Prof.

Investigator Role:

Principal Investigator

Investigator Affiliation:

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

Authority:

Poland: Ministry of Science and Higher Education

Study ID:

CAVITY

NCT ID:

NCT01535209

Start Date:

January 2012

Completion Date:

December 2014

Related Keywords:

  • Brain Metastases
  • Stereotactic radiotherapy
  • Whole-brain radiotherapy
  • Resection cavity
  • Neoplasm Metastasis
  • Neoplasms, Second Primary
  • Brain Neoplasms

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