Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 9:38 PM
Ignite Modification Date:
2025-12-24 @ 9:38 PM
NCT ID:
NCT01614132
Eligibility Criteria:
Inclusion Criteria:
* age \> 18 years
* medulloblastoma (+/- postoperative residual tumor, M0) or medulloblastoma (+/- postoperative residual tumor, M1-M3) respectively
* primary diagnosis of the tumor
* no previous chemo- or radiation therapy
* Karnofsky-Index ≥ 70%
* WBC ≥ 3000/μl; thrombocytes ≥ 100 000/μl; Hb ≥ 10 g/dl
* creatinine =\< 1,5 ULN; Bilirubin =\< 1,5 ULN; GPT, GOT, AP =\< 2,5 ULN
* HIV and hepatitis B/C negative
* no factors / any medical condition affecting patient's compliance
* patient needs to fulfil protocol's requirements
* patient is willing to use highly effective methods of contraception during dosing and for 6 months after the last dose; women of child-bearing potential must have a negative hCG laboratory test at baseline; pregnancy tests must be repeated every 4 weeks
* patient's written consent
Exclusion Criteria:
* age \< 18 years
* histologically not confirmed Medulloblastoma
* by chemo- or radiotherapy treated recidive tumor
* other cancer (with exception of surgically cured carcinoma in situ of the cervix and non-melanocytic skin tumors)
* hypersensitivity or contraindication against one of the used drugs
* current or planned participation to another clinical trial during this study Any other condition which, in the opinion of the Investigator, would make the patient unsuitable for enrolment or could interfere with the patient participating in and completing the study
* Any medical condition associated with high medical risk or contraindicated to use chemotherapeutic agents as indicated in current product package insert
* Pregnant or nursing (lactating) women; women or men not willing to use a highly effective methods of contraception
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT01614132
Study Brief:
Protocol Section:
NCT01614132