Status:
COMPLETED
Carbon Ion Radiotherapy for Recurrent Gliomas
Lead Sponsor:
University Hospital Heidelberg
Conditions:
Glioma
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Treatment of patients with recurrent glioma includes neurosurgical resection, chemotherapy, or radiation therapy. In most cases, a full course of radiotherapy has been applied after primary diagnosis,...
Eligibility Criteria
Inclusion
- unifocal, supratentorial recurrent glioma
- contrast enhancement on T1-weighted MRI and/or Amino-Acid-PET-positive high-grade tumor areas
- indication re-irradiation
- age ≥ 18 years of age
- Karnofsky Performance Score ≥60
- For women with childbearing potential, (and men) adequate contraception.
- Ability of subject to understand character and individual consequences of the clinical trial
- Written informed consent (must be available before enrolment in the trial)
Exclusion
- Multifocal Glioma or Gliomatosis cerebri
- refusal of the patients to take part in the study
- previous re-irradiation or prior radiosurgery or prio treatment with interstitial radioactive seeds
- time interval of \< 6 months after primary radiotherapy
- Patients who have not yet recovered from acute toxicities of prior therapies
- Known carcinoma \< 5 years ago (excluding Carcinoma in situ of the cervix, basal cell carcinoma, squamous cell carcinoma of the skin) requiring immediate treatment interfering with study therapy
- Pregnant or lactating women
- Participation in another clinical study or observation period of competing trials, respectively.
Key Trial Info
Start Date :
December 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2016
Estimated Enrollment :
56 Patients enrolled
Trial Details
Trial ID
NCT01166308
Start Date
December 1 2010
End Date
April 1 2016
Last Update
May 17 2018
Active Locations (1)
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1
University Hospital of Heidelberg, Department of Radiation Oncology
Heidelberg, Germany, 69120