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Randomised Phase I/II Study to Evaluate Carbon Ion Radiotherapy Versus Fractionated Stereotactic Radiotherapy in Patients With Recurrent or Progressive Gliomas: The CINDERELLA Trial


Phase 1/Phase 2
18 Years
N/A
Open (Enrolling)
Both
Glioma

Thank you

Trial Information

Randomised Phase I/II Study to Evaluate Carbon Ion Radiotherapy Versus Fractionated Stereotactic Radiotherapy in Patients With Recurrent or Progressive Gliomas: The CINDERELLA Trial


Inclusion Criteria:



- 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 Criteria:

- 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.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Overall Survival

Outcome Time Frame:

at 12 months

Safety Issue:

No

Authority:

Germany: Federal Office for Radiation Protection

Study ID:

CINDERELLA

NCT ID:

NCT01166308

Start Date:

August 2010

Completion Date:

August 2015

Related Keywords:

  • Glioma
  • Recurrent Glioma
  • Glioma

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