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Completed

NCT Number: NCT03561896

Hypofractionated Brain Radiationcavity

Stereotactic radiosurgery or hypofractionated radiotherapy of the resection cavity after metastasectomy in cancer patients with brain metastases

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Oncology Institute of Southern Switzerland (IOSI), Bellinzona, Canton Ticino, Switzerland

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About this study

Patients with limited number of brain metastases from solid tumors are at high risk of local recurrence after surgical removal of the tumor mass. The standard Whole-brain radiotherapy (WBRT) demonstrated to reduce the risk of recurrence without improving survival. At the same time WBRT have substantial acute and late toxicity. Preliminary experiences with Stereotactic radiosurgery or hypofractionated radiotherapy of the resection cavity indicate promising local control and good tolerance. This attitude was only partially explored in prospective trials. In this research patients with limited number of brain metastases and controlled systemic disease will be treated, with such a stereotactic irradiation, at the same time with evaluation of the local control (Primary endpoint) by repeated MRI and of quality of life, neurologic functionning (with a battery of thsts, e.g. MMSE, QLQ-C30, EORTC BN-20) as well as overall survival as secondary endpoints.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patient underwent surgery for single brain metastasis arising from solid neoplasia (lung, breast, melanoma, kidney, colorectal), with initial histological diagnosis, or selected cases with a resected lesion and a further non-resected lesion (from 1 to 2 lesions), treatable with SRS / IGRT of the surgical cavity
  • Patient ≥ 18 years
  • Willngness to participate in the study, written informed consent
  • Performance Status according to WHO 0-I
  • Good general conditions and organ function
  • Newly diagnosed chemotherapy-naïve disease or controlled systemic disease
  • Good bone marrow, renal and hepatic function
  • Stable steroid dose or reduced for at least 5 days

Exclusion criteria

  • History of previous brain irradiation
  • Pregnancy or breastfeeding
  • Histological diagnosis other than lung, breast, melanoma, kidney and colorectal malignancy

Treatment and study plan

IGRT

Radiation

Image-Guided Radiation Therapy

SRS

Radiation

stereotactic radiation therapy

Primary outcomes

  1. Relapse rate

    Time frame: 1 year

    Evaluate the recurrence probability in the surgical cavity after radiotherapy

Secondary outcomes

  1. Overall survival

    Time frame: 1 year

    The proportion of surviving patients at 1 year

  2. Time to systemic progression

    Time frame: 1 year

    The proportion of patients with progression of disease in any location other than the brain, according to CTCAE Criteria

  3. Time to neurological progression

    Time frame: 1 year

    Time to neurological deterioration (objective neurological examination and MMSE)

  4. Quality of life assessment

    Time frame: 1 year

    Evaluation of the quality of life through questionnaire

Sponsors and collaborators

Lead sponsor

Oncology Institute of Southern Switzerland

Other

Registry information

Official study title

Stereotactic Radiosurgery or Hypofractionated Image-Guided Radiotherapy to the Surgical Cavity After Resection of Brain Metastases: a Multicenter, Single Arm, Open-label, Phase II Trial

Important dates

Study start
2015
Primary completion
2024
Study completion
2024
First posted
Jun 19, 2018
Registry last updated
Jul 17, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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