CPT-SIOP-2000

Author: Dr. med. Ralf Herold, erstellt 2007/01/30, Last modification: 2011/05/09

Title Treatment of tumors of the choroid plexus epithelium. An intercontinental phase III chemotherapy study for patients with choroid plexus tumors
Disease Tumors of the Plexus choroideus
Therapy / Study arms

After maximal possible resection, all patients with Choroid Plexus carcinoma (CPC), metastasized tumors and incompletely resected atypical plexus papilloma ree randomized to a treatment with either carboplatin or cyclophosphamide given together with etoposide and vincristine. After the first interim analysis at the committee meeting in Vancouver 2005, it was decided to stratify the randomization by age to keep an even number of radiated patients in each treatment group. A total of 6 courses of chemotherapy (VP16 100 mg/m2 d1-5, vincristine 1.5 mg/m2 d1 and either carboplatin 350 mg/m2 d1+2 or cyclophosphamide 1000 mg/m2 d1+2), and additional irradiation after the second course for those who are older than 3 years of age was given. Patients with metastasized atypical choroid plexus papilloma (APP) and CPC, and patients with non-metastasized CPC non-responsive to chemotherapy (Stable desease, Progressive desease) received craniospinal irradiation with 35 Gy and local boost up to a total of 54 Gy. Patients with choroid plexus papilloma and completely resected atypical papilloma were closely followed without further treatment.

Inclusion Criteria

Eligibility criteria for first registration (registration and follow-up study)

  • Histological diagnosis of a choroid plexus tumor by a local pathologist / neuropathologist. This includes choroid plexus papilloma, atypical choroid plexus papilloma, anaplastic choroid plexus papilloma, malignant choroid plexus papilloma, and choroid plexus carcinoma. WHO brain tumor classification 1.5.1 and 1.5.2 (Kleihues 1993), ICD-O classification M-9390/0, M-9390/3 (WHO 1990)
  • Slides have been sent to the pathology reference centre (by declaration of the sending centre)

Eligibility criteria for registration for randomization (center depended voluntary second registration or treatment study)

  • The first registration on the study was completed
  • The reference centre has confirmed the receipt of slides sent
  • The postoperative imaging has been done and the result is available
  • The indication criteria are met
  • The chemotherapy start criteria are met
  • The agreement of patient or legal guardian has been documented according to the local guidelines
Exclusion Criteria
  • Patient or legal guardian does not consent to enrollment with electronic data processing or sending of tumor slides to the pathology reference centre
Status Beginn 28.10.2000 Ende 12.03.2010
Principal Investigator Prof. Dr. med. Johannes E. A. Wolff
E-Mail mailto:jwolff@mdanderson.org
Contact

Nationaler Studienleiter Deutschland

PD Dr. med. Uwe Richard Kordes
Universitätsklinikum Hamburg-Eppendorf
Klinik und Poliklinik f. Päd. Hämatologie u. Onkologie
Martinistraße 52
20246 Hamburg
Telefon +49 (40) 7410 59199
Fax +49 (40) 7410-57544

Weitere Informationen The trial has been closed in March 2010. In summer 2010 a new registry will be started.
Documents
Link(s) Geschützte Dokumente
Sponsoring Deutsche Kinderkrebsstiftung (Bonn)