Clinical Trial Details
Braintumor Website

[Information provided by: ClinicalTrials.gov, which provides patients, family members, and members of the public easy and free access to information on clinical studies for a wide range of diseases and conditions.]

NCT02520635 : Supra-early Post-Surgery Chemotherapy in the Treatment on GBM Patients
PhasePhase 4
AgesMin: 18 Years Max: 70 Years
Eligibility
Inclusion Criteria:

1. Patients with prior histological confirmation of newly diagnosed primary glioblastoma
multiforme in supratentorial cerebral hemisphere.

2. Gross total resection or partial resection (imaging) >70%.

3. Chemo-radiotherapy to be expected from Week 5 (Day 29) after surgery.

4. Age >=18 and <=70 years.

5. Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2.

6. Life expectancy >=9 months.

7. Laboratory test values must satisfy the following criteria:

1. absolute neutrophil count >=1.5 x 10^9/L;

2. platelet count >=100 x 10^9/L;

3. hemoglobin >=80 g/L;

4. blood urea nitrogen and creatinine < 1.5 x upper limit of normal value (ULN);

5. total bilirubin and direct bilirubin < 1.5 x ULN;

6. alanine aminotransferase and aspartate aminotransferase < 3 x ULN;

7. alkaline phosphatase < 2 x ULN.

8. Patients must be willing to provide written informed consent.

9. Patients of child-bearing potential (including female subjects and the female partners
of male subjects) must use an effective method of contraception.

Exclusion Criteria:

1. Patients without prior histological confirmation of primary glioblastoma multiforme.

2. Patient with previous or current malignancies at other sites.

3. Patient who received chemotherapy, radiotherapy for study indication, or other
medications for antitumor indication prior to surgery.

4. Patient with recurrent or multiple malignant glioma (including gliomatosis cerebri).

5. Patient with metastatic lesions at the subtentorial or outside of calvaria.

6. Patient who received chemotherapy or radiotherapy sensitizers for head or neck tumor.

7. Patient who received radiotherapy at head or neck which leads to radiotherapy domain
overlapping.

8. Frequent vomiting or medical condition that could interfere with oral medication
intake (eg, partial bowel obstruction).

9. Known human immunodeficiency virus (HIV)-positive or acquired immune deficiency
syndrome (AIDS)-related illness.

10. Woman who is pregnant or breastfeeding.

11. Patient with a history of hypersensitivity to temozolomide or other analogic
alkylating agents.

12. Patient with severe myelosuppression

13. Patient with any other conditions under which investigators think the subject is not
suitable for enrolment, such like having known that the subject may not have good
compliance.
LinksPermanent Link to THIS page: https://virtualtrials.com/nct/display1trial.cfm?nct=NCT02520635      |      Link to official Clinicaltrials.gov listing
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