SIOP PNET 5 MB

автор: Julia Dobke, erstellt am: 2014/09/08, Последнее изменение: 2015/06/15

титул AN INTERNATIONAL PROSPECTIVE STUDY ON CLINICALLY STANDARD-RISK MEDULLOBLASTOMA IN CHILDREN OLDER THAN 3 TO 5 YEARS WITH LOW-RISK BIOLOGICAL PROFILE (PNET 5 MB - LR) OR AVERAGE-RISK BIOLOGICAL PROFILE (PNET 5 MB -SR)
Формы рака Standardrisk-Medulloblastoma
Вид исследования International, prospective, Phase-II trial
Цель исследования

Primary objective LR-group

To confirm that the 3-year Event-Free Survival (EFS) rate in children and adolescents with standard-risk medulloblastoma having a low-risk biological profile remains in excess of 80% when patients are treated with 23.4 Gy neuraxis irradiation plus boost to the primary tumor, and reduced-intensity chemotherapy.

Primary objective SR-group

To test whether the Event-Free Survival (EFS) in children and adolescents with standard-risk medulloblastoma having an average-risk biological profile is different for patients treated with or without carboplatin concomitantly with radiotherapy (23.4 Gy neuraxis irradiation plus boost to the primary tumor) followed by a modified maintenance chemotherapy.

Лечение

Low-Risk-group (LR)

Chemotherapy:

Maintenance chemotherapy starts 6 weeks after radiotherapy.
6 cycles alternating Regimen A and Regimen B.
Regimen A (cycles 1, 3, 5): cisplatin , CCNU, vincristine
Regimen B: (cycles 2, 4, 6): cyclophosphamide, vincristine
Total duration of 27weeks.

Standard-risk-group (SR)

Radiotherapy:
CNS: 23,4 Gy
Spine: 23,4 Gy
Primary tumor boost: 30,6 Gy
Total dose to primary – 54 Gy in 30 daily fractions of 1.80 Gy
With or without carboplatin 35 mg/m2 5 times/week.

Chemotherapy:
Maintenance chemotherapy starts 6 weeks after radiotherapy. 8 cycles alternating Regimen A and Regimen B.
Regimen A (cycles 1, 3, 5, 7): cisplatin, CCNU, vincristine
Regimen B: (cycles 2, 4, 6, 8): cyclophosphamide, vincristine

Кого берут в протокол
  • Age at diagnosis, at least 3 - 5 years (depending on the country) and less than 22 years. The date of diagnosis is the date on which surgery is undertaken
  • Histologically proven medulloblastoma, including the following subtypes, as defined in the WHO classification (2007): - classic medulloblastoma, - desmoplastic/nodular medulloblastoma; pre-treatment central pathology review is considered mandatory.
  • Standard-risk medulloblastoma
  • Submission of high quality biological material including fresh frozen tumor samples for the molecular assessment of biological markers (such as the assessment of MYC gene copy number status) in national biological reference centers.
  • No amplification of MYC or MYCN (determined by FISH)
  • LR: Low-risk biological profile, defined as ß-catenin nuclear immunopositivity by IHC (mandatory) and / or mutation analysis (optional);
  • SR: average-risk biological profile, defined as ß-catenin nuclear immunonegativity by IHC (mandatory) and mutation analysis (optional) .
  • CTC grades < 2 for liver, renal, haematological function
  • no significant sensineural hearing deficit
  • No medical contraindication to radiotherapy or chemotherapy,
  • No identified Turcot and Li Fraumeni syndrome.
  • Written informed consent (and patient assent where appropriate) for therapy according to the laws of each participating country.
  • National and local ethical committee approval according to the laws of each participating country (to include approval for biological studies).
Кого не берут в протокол
  • One of the inclusion criteria is lacking;
  • Other histology than classic medulloblastoma or desmoplastic/nodular medulloblastoma;
  • Medulloblastoma is no standard-risk;
  • Patients who are pregnant:
  • Female patients who are sexually active and not taking reliable contraception;
  • Patients who cannot be regularly followed up due to psychological, social, familial or geographic reasons;.
  • Patients in whom non-compliance with toxicity management guidelines can be expected.
EudraCT 2011-004868-30
Entry Study Register
Руководитель протокола Prof. Dr. med. Stefan Rutkowski
E-Mail mailto:hitchem@uke.de
С кем можно связаться

Co-coordinating Investigator

Dr. med. Katja von Hoff
Universitätsklinikum Hamburg-Eppendorf
Klinik für Pädiatrische Hämatologie und Onkologie
Martinistr. 52
20246 Hamburg
Telefon +49 (40) 7410-53394
Fax +49 (40) 7410 58300
k.von-hoff@uke.de

Study coordination

Dr. med. Martin Mynarek
Universitätsklinikum Hamburg-Eppendorf
Klinik für Pädiatrische Hämatologie und Onkologie
Martinistr. 52
20246 Hamburg
Telefon +49 (0)40 74 10-5 33 94
m.mynarek@uke.de

Data management

Susanne Becker
Uni­ver­si­täts­kli­ni­kum Ham­burg-​Ep­pen­dorf
Kli­nik u. Po­li­kli­nik f. Päd. On­ko­lo­gie u. Hä­ma­to­lo­gie, Haus N21, Stu­di­en­zen­tra­le HIT2000
Martinistr. 52
20246 Ham­burg
Telefon +49 (40) 7410 58200
Fax +49 (40) 7410 58300
hitchem@uke.de

Antje Stiegmann
Universitätsklinikum Hamburg-Eppendorf
Kli­nik u. Po­li­kli­nik f. Päd. On­ko­lo­gie u. Hä­ma­to­lo­gie, Haus N21, Stu­di­en­zen­tra­le HIT2000
Martinistr. 52
20246 Hamburg
Telefon +49 (40) 7410 58200
Fax +49 (40) 7410 58300
hitchem@uke.de

Участники исследования Österreich, Belgien, Tschechische Republik, Dänemark, Frankreich, Deutschland, Irland, Italien, Norwegen, Polen, Portugal, Spanien, Schweden, Schweiz, Niederlande, Großbritannien
Weitere Informationen Amendment 2018, version 12
Внутренние ссылки Studienliteratur zu den Medulloblastomen
Кто финансирует Deutsche Kinderkrebsstiftung