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

Randomised phase I/II study to evaluate carbon ion radiotherapy versus fractionated stereotactic radiotherapy in patients with recurrent or progressive gliomas

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN01460925

Enrollment

436

Registered

2011-02-07

Start date

2010-09-01

Completion date

Unknown

Last updated

2015-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Recurrent glioma Cancer Malignant neoplasm of brain

Interventions

Phase I: Dose Escalation - Patients fulfilling the inclusion criteria will be treated with increasing total dose of carbon ion radiotherapy to evaluate the optimal carbon ion dose with respect to toxi

Eligibility

Sex/Gender

All

Inclusion criteria

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

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

Design outcomes

Primary

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

Secondary

Measure	Time frame
1. Phase I: Survival after re-irradiation 2. Phase II: 2.1. Progression-free survival at 12 months 2.2. Toxicity 2.3. Safety	—

Countries

Germany

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026