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Carbon Ion Radiotherapy for Recurrent Gliomas

Study Purpose

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, therefore application of re-irradiation has to be applied cautiously. With modern precision photon techniques such as fractionated stereotactic radiotherapy (FSRT), a second course of radiotherapy is safe and effective and leads to survival times of 22, 16 and 8 months for recurrent WHO grade II, III and IV tumors. Carbon ions offer physical and biological characteristics. Due to their inverted dose profile and the high local dose deposition within the Bragg peak precise dose application and sparing of normal tissue is possible. Moreover, in comparison to photons, carbon ions offer an increase relative biological effectiveness (RBE), which can be calculated between 2 and 5 depending on the Glioblastoma (GBM) cell line as well as the endpoint analyzed. Protons, however, offer an RBE which is comparable to photons. First Japanese Data on the evaluation of carbon ion radiation therapy for the treatment of primary high-grade gliomas showed promising results in a small and heterogeneous patient collective. In the current Phase I/II-CINDERELLA-trial re-irradiation using carbon ions will be compared to FSRT applied to the area of contrast enhancement representing high-grade tumor areas in patients with recurrent gliomas. Within the Phase I Part of the trial, the Recommended Dose (RD) of carbon ion radiotherapy will be determined in a dose escalation scheme. In the subsequent randomized Phase II part, the RD will be evaluated in the experimental arm, compared to the standard arm, FSRT with a total dose of 36 Gy in single doses of 2 Gy. Primary endpoint of the Phase I part is toxicity. Primary endpoint of the randomized part II is survival after re-irradiation at 12 months, secondary endpoint is progression-free survival.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion Criteria

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.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT01166308
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

N/A
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

University Hospital Heidelberg
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

N/A
Principal Investigator Affiliation N/A
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other
Overall Status Completed
Countries Germany
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Glioma
Arms & Interventions

Arms

Experimental: Carbon Ion Radiotherapy

Carbon Ion Radiotherapy in the RD determined within the Phase I Part of the Trial

Active Comparator: Standard Treatment: Fractionated Stereotacitc Radiotherapy

Standard Precision Radiotherapy performed as Fractionated Stereotactic Radiotherapy (FSRT) up to 36 Gy in single dosis of 2 Gy

Interventions

Radiation: - Carbon Ion Radiotherapy

Carbon Ion Radiotherapy in the RD determined within the Phase I part of the Study (10 x 3Gy E to 16 x 3 Gy E)

Radiation: - Fractionated Stereotactic Radiotherapy (FSRT)

Standard Treatment as Re-Irradiation performed as Fractionated Stereotactic Radiotherapy (FSRT)up to 36 Gy in single doses of 2 Gy

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Heidelberg, Germany

Status

Address

University Hospital of Heidelberg, Department of Radiation Oncology

Heidelberg, , 69120