Multicentric pilot study for the treatment of medulloblastoma in adults
Organizational Data
- DRKS-ID:
- DRKS00002072
- Recruitment Status:
- Recruiting complete, study continuing
- Date of registration in DRKS:
- 2012-08-23
- Last update in DRKS:
- 2015-01-22
- Registration type:
- Retrospective
Acronym/abbreviation of the study
NOA-7
URL of the study
http://www.neuroonkologie.de/fileadmin/neuroonkologie/pdf/0_NOA07_KurzP_1.2_010208.pdf
Brief summary in lay language
Medulloblastoma is the most common malign tumor in children and adolescents. Medulloblastoma in adults are relaltively infrequent with an amount of 1% of all brain tumors in adulthood. Until now most adult patients with medulloblastoma were treated according to paediatric protocols or individual therapy regimes. This study intends for the first time a prospective data ascertainment for the treatment of adults with a therapy, which is up to now known as standard therapy of children. The primary purpose is the examination of discontinuation due to toxicity and also to determine the toxicity of maintenance chemotherapy. Secondly the objective is to identify the 3 and 5 year progression-free survival (PFS), event-free survival (EFS) as well as the overall survival (OS) and to compare PFS with the historical comparison group from the HIT’91-Study
Brief summary in scientific language
Therapy of Medulloblastoma in Adults Phase II/Pilotstudy
Health condition or problem studied
- ICD10:
- C71.6 - Cerebellum
- Healthy volunteers:
- No Entry
Interventions, Observational Groups
- Arm 1:
- Radiotherapy, chemotherapy with vincristine, CCNU and cisplatin
Endpoints
- Primary outcome:
- Compatibility, number of discontinuation due to toxicity
- Secondary outcome:
- 3 and 5 year progression-free survival (PFS)
Study Design
- Purpose:
- Treatment
- Allocation:
- N/A (single arm study)
- Control:
-
- Uncontrolled/single arm
- Phase:
- II
- Study type:
- Interventional
- Mechanism of allocation concealment:
- No Entry
- Blinding:
- No
- Assignment:
- Single (group)
- Sequence generation:
- No Entry
- Who is blinded:
- No Entry
Recruitment
- Recruitment Status:
- Recruiting complete, study continuing
- Reason if recruiting stopped or withdrawn:
- No Entry
Recruitment Locations
- Recruitment countries:
-
- Germany
- Number of study centers:
- Multicenter study
- Recruitment location(s):
- No Entry
Recruitment period and number of participants
- Planned study start date:
- No Entry
- Actual study start date:
- 2009-01-26
- Planned study completion date:
- No Entry
- Actual Study Completion Date:
- No Entry
- Target Sample Size:
- 30
- Final Sample Size:
- 33
Inclusion Criteria
- Sex:
- All
- Minimum Age:
- 18 Years
- Maximum Age:
- no maximum age
- Additional Inclusion Criteria:
- Age of at least 18 years (see chapter 5) Medulloblastoma (+/- post operative residual tumor, M0) respectively medulloblastoma (+/- post operative residual tumor, M1-3) (local pathologist, reference histological confirmed immediately after study participation (see chapter 5 and Annex) Initial diagnosis of the tumor None prior chemotherapy or radiotherapy Performance status >= 70% Intact blood count (postoperative): leucocytes>= 3000/µl; thrombocytes >= 100000/µl; hemoglobin (Hb) >= 10 g/dl Intact liver and kidney function: Creatinine <= 1.5 times of upper limit; Bilirubin <= 1.5 times of upper limit, glutamic pyruvic transaminase (GPT), glutamic oxaloacetic transaminase (GOT), alkaline phosphatase (AP) <= 2.5 times of upper limit Clinical and chemically exclusion of HIV or hepatitis C/B infection Exclusion psychical, familial, social and geographical factors, which could effect the patient compliance Patients, who are in a position to achieve all study requirements Patients who are willing to use contraception during treatment. Women of childbearing potential have to be tested negative by a pregnancy test in the baseline examination. Men and women have to practice an effective method of contraception (double barrier) during the study and at least 6 month after discontinuing study medication, this also applies patients with known infertility. Written informed consent
Exclusion Criteria
Age < 18 years (see chapter 5) Histological not considered medulloblastoma Prior treated recurrent tumor by radiotherapy or chemotherapy Other tumor diseases (in exception a chirurgical cured carcinoma in situ of cervix and a non-melanocytic skin tumor) Allergy or contraindication against one of the substances used in the study Participation in other therapy studies Severe affecting, life-limiting diseases according to the investigator and also every other medical condition precluding adequate execution of the trial from treating physican’s point of view. Women of childbearing potential planning to become pregnant, are pregnant or are breast-feeding, and/or not willing to practice an adequate method of contraception; Men not willing to practice an adequate method of contraception
Addresses
Primary Sponsor
- Address:
- Klinik für Neurologie der Universität RegensburgProf. Dr. Ulrich BodgahnUniversitätsstraße 8493053 RegensburgGermany
- Telephone:
- 09419413001
- Fax:
- 094194163256
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://www.uni-regensburg.de/Fakultaeten/Medizin/Neurologie/
- Investigator Sponsored/Initiated Trial (IST/IIT):
- No
Contact for Scientific Queries
- Address:
- Klinik für Neurologie der Universität RegensburgProf. Peter HauUniversitätsstraße 8493053 RegensburgGermany
- Telephone:
- 09419418083
- Fax:
- 09419413292
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://www.uni-regensburg.de/Fakultaeten/Medizin/Neurologie/
Contact for Public Queries
- Address:
- Neurologische Klinik der Universität RegensburgProf. Dr. Peter HauUniversitätsstrasse 8493053 RegensburgGermany
- Telephone:
- 0941-941-8083
- Fax:
- 0941-941-63256
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Sources of Monetary or Material Support
Institutional budget, no external funding (budget of sponsor/PI)
- Address:
- Klinik für Neurologie der Universität RegensburgUniversitätsstrasse 8493053 RegensburgGermany
- Telephone:
- 0941 9413001
- Fax:
- 0941 9413005
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://www.uni-regensburg.de
Ethics Committee
Address Ethics Committee
- Address:
- Ethik-Kommission der Albert-Ludwigs-Universität FreiburgEngelberger Str. 2179106 FreiburgGermany
- Telephone:
- +49-761-27072600
- Fax:
- +49-761-27072630
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Vote of leading Ethics Committee
- Vote of leading Ethics Committee
- Date of ethics committee application:
- 2008-05-08
- Ethics committee number:
- 160/08
- Vote of the Ethics Committee:
- Approved
- Date of the vote:
- 2008-05-13
Further identification numbers
- Other primary registry ID:
- No Entry
- EudraCT Number:
- 2007-002560-10
- Other secondary IDs:
- 4034313 - bfarm-nr
- Other secondary IDs:
- UKF001662 - Register klinischer Studien des Universitätsklinikums Freiburg
IPD - Individual Participant Data
- Do you plan to make participant-related data (IPD) available to other researchers in an anonymized form?:
- No Entry
- IPD Sharing Plan:
- No Entry
Study protocol and other study documents
- Study protocols:
- No Entry
- Study abstract:
- No Entry
- Other study documents:
- No Entry
- Background literature:
- No Entry
- Related DRKS studies:
- No Entry
Publication of study results
- Planned publication:
- No Entry
- Publikationen/Studienergebnisse:
- No Entry
- Date of first publication of study results:
- No Entry
- DRKS entry published for the first time with results:
- No Entry
Basic reporting
- Basic Reporting / Results tables:
- No Entry
- Brief summary of results:
- No Entry