Carbon ion radiotherapy versus fractionated stereotactic radiotherapy in patients with recurrent or progressive gliomas: the CINDERELLA trial

Completed

• Conditions: Recurrent glioma; Cancer; Malignant neoplasm of brain

• Registration Number: ISRCTN01460925
• Lead Sponsor: niversity Hospital of Heidelberg (Germany)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-02-07
• Last Update Posted: 13 January 2015

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 436

Inclusion Criteria

1. Unifocal, supratentorial recurrent glioma
2. Contrast enhancement on T1-weighted magnetic resonance imaging (MRI) and/or amino acid positron emission tomography (PET)-positive high-grade tumour areas
3. Indication re-irradiation
4. Aged greater than or equal to 18 years of age, either sex
5. Karnofsky Performance Score greater than or equal to 60
6. For women with childbearing potential, (and men) adequate contraception
7. Ability of subject to understand character and individual consequences of the clinical trial
8. Written informed consent (must be available before enrolment in the trial)

Exclusion Criteria

1. Multifocal glioma or gliomatosis cerebri
2. Refusal of the patients to take part in the study
3. Previous re-irradiation or prior radiosurgery or prior treatment with interstitial radioactive seeds
4. Time interval of less than 6 months after primary radiotherapy
5. Patients who have not yet recovered from acute toxicities of prior therapies
6. Known carcinoma less than 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
7. Pregnant or lactating women
8. Participation in another clinical study or observation period of competing trials, respectively

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. Phase I: Any Grade IV toxicity related to the study treatment according to Common Toxicity Criteria for Adverse Events (CTCAE) Grade IV<br>2. Phase II: Survival after re-irradiation at 12 months

Secondary Outcome Measures

Name	Time	Method
1. Phase I: Survival after re-irradiation<br>2. Phase II: <br>2.1. Progression-free survival at 12 months<br>2.2. Toxicity<br>2.3. Safety