Clinical Trial: Re-irradiation of High Grade Gliomas: a Quality of Life Study

Study Status: Withdrawn
Recruit Status: Withdrawn
Study Type: Observational

Official Title: Re-irradiation of High Grade Gliomas: a Quality of Life Study

Brief Summary: Patients with a high grade glioma have an increasing overall survival and progression free survival after initial treatment. Because of a better performance status these patients are more often eligible for re-treatment with for example radiotherapy. However, to date only a few prospective studies on re-irradiation of gliomas exist and very little is known about the effects of re-irradiation on quality of life and cognition. This trial is designed to longitudinally establish the effects of re-irradiation on quality of life, cognition and physical performance in patients with a high grade glioma. Based on the currently available information the investigators hypothesize that quality of life after re-irradiation can be kept stable until further tumour progression.

Detailed Summary:

Current treatment regimes, with the addition of temozolomide, have improved progression-free survival as well as overall survival for patients with a high grade glioma. The median overall survival (MOS) for patients with a glioblastoma (GBM) is 14.6 months, with a progression free survival (PFS) of 6.9 months.

Due to longer survival and a better performance status, patients often reach a point at which re-treatment is feasible. Treatment options for recurrent glioblastoma and anaplastic glioma can include surgery, chemotherapy and re-irradiation. Re-irradiation of patients with recurrent high grade glioma is slowly becoming standard of care. It provides a comparable overall survival to palliative chemotherapy. In case of GBM there is a median time to progression after treatment of 20-27 weeks and a MOS of 26 to 60 weeks.

Patients with tumor recurrence have a significantly worse quality of life compared to patients without recurrence at the same follow-up. They experience significantly more problems with physical functioning (e.g. motor dysfunction, weakness of legs, visual disorders), work or other daily activities, mental health (e.g. future uncertainty) and general health.

With regard to re-irradiation, current available data is mostly provided by retrospective studies which often lack solid quality of life data. Endpoints include e.g. performance status, clinical (neurological) status and decreased steroid requirement after treatment. These endpoints are however inadequate to determine quality of life accurately.

Several studies have used the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire core 30 (EORTC QLQ-C30) and the brain cancer module (QLQ-BN20) scales to assess quality of li
Sponsor: Maastricht Radiation Oncology

Current Primary Outcome: Change from baseline in the palliative effect of re-irradiation in patients with a high grade glioma, defined by quality-of-life parameters [ Time Frame: baseline, 6-8weeks, 12 weeks, 18-20 weeks, 30-32 weeks ]

These Quality of life parameters include:

  • The change in the EORTC QLQ-C30 score from baseline to endpoint
  • The change in the EORTC QLQ-BN20 score from baseline to endpoint
  • The change in the EORTC QLQ-FA13 score from baseline to endpoint
  • The change in cognition from baseline to endpoint as measured by the HVLT-R, the TMT, the Stroop-test and the COWA
  • The change in grip strength from baseline to endpoint


Original Primary Outcome: Change from baseline in the palliative effect of re-irradiation in patients with a high grade glioma, defined by quality-of-life parameters [ Time Frame: baseline, 6-8weeks, 12 weeks, 18-20 weeks, 30-32 weeks ]

These Quality of life parameters include:

  • The change in the EORTC quality of life score from baseline to endpoint.
  • The change in the EORTC FA-13 from baseline to endpoint
  • The change in cognition from baseline to endpoint as measured by the MoCA, the HVLT-R, Stroop and the COWA
  • The change in grip strength from baseline to endpoint


Current Secondary Outcome:

  • Overall survival of patients with glioblastoma and anaplastic glioma after re-irradiation [ Time Frame: 6 months after the last patient is included ]
    - Months from the start of re-irradiation to death
  • Progression free survival of patients with glioblastoma and anaplastic glioma after re-irradiation [ Time Frame: 6 months after the last patient is included ]
    - Months from the start of re-irradiation to tumorprogression


Original Secondary Outcome:

  • Overall survival of patients with glioblastoma multiforme and anaplastic glioma after re-irradiation [ Time Frame: 6 months after the last patient is included ]
    - Months from the start of re-irradiation to death
  • The relationship between quality of life of the primary caregiver and the subject [ Time Frame: baseline, 6-8weeks, 12 weeks, 18-20 weeks, 30-32 weeks ]
    - The change in quality of life from the primary caregiver from baseline to endpoint measured by the SF-36
  • Progression free survival of patients with glioblastoma multiforme and anaplastic glioma after re-irradiation [ Time Frame: 6 months after the last patient is included ]
    - Months from the start of re-irradiation to tumorprogression


Information By: Maastricht Radiation Oncology

Dates:
Date Received: October 12, 2012
Date Started: March 2013
Date Completion: September 2015
Last Updated: May 11, 2015
Last Verified: May 2015