Status:
UNKNOWN
A Prospective Cohort to Study the Effect of Temozolomide on IDH Mutational Low Grade Gliomas
Lead Sponsor:
Huashan Hospital
Conditions:
Astrocytoma
Oligodendroglioma
Eligibility:
All Genders
18-40 years
Phase:
PHASE2
Brief Summary
Low grade gliomas (LGGs) are the most common primary central nervous system malignancies. Brain surgeries with the most possible extent of resection are endeavored to achieve longer survivals in LGG p...
Detailed Description
Low grade gliomas, according to the 2007 WHO classification of tumors of the central nervous system, include astrocytomas, oligodendrogliomas, and oligoastrocytomas. It contributes to 25% of diffuse g...
Eligibility Criteria
Inclusion
- 18 years \< age ≤ 40 years, both genders.
- No neurologic cognitive deficits (MMSE ≥ 27), no psychiatric abnormalities before surgery, pre-operative KPS ≥ 80.
- Tumors located in eloquent areas or deeply located nuclei, rendering radiological complete resection inapplicable, according to updated standards of extent of resection: as for non-enhancing LGG, postoperative MRI within 72h shows absence of any preoperative T2/FLAIR signal changes - complete resection; and for enhancing LGG, postoperative MRI shows total removal of preoperative enhancing tissue - complete resection of enhancing tumor; and total removal of enhancing and non-enhancing tissues (T2/FLAIR) - complete resection of detectable tumor.
- Post-operative histological pathology confirms LGGs (astrocytomas, oligodendrogliomas, or oligoastrocytomas, 2007 WHO classification Grade II).
- No contraindications to TMZ chemotherapy.
- Informed consent to TMZ chemotherapy.
Exclusion
- Tumor involves more than 3 cerebral lobes (gliomatosis or multiple gliomas).
- Tumor is complicated with other intracranial neoplasms (e.g. metastatic tumors or meningiomas).
- Tumor is complicated with systematic malignancies.
- Dysfunctions of other vital organs: liver and kidney (ALT﹥40U/L, AST \> 40U/L, creatinine \> 97-106μmol/L, urea nitrogen \> 7.1mmol/L, or other lab abnormalities); Heart (NYHA II-IV); Lungs (hypoxemia).
- Physiological pregnancy.
- Participate in other clinical trials at meantime.
- History of severe anaphylaxis.
- Voluntarily quit or decline chemotherapy.
Key Trial Info
Start Date :
June 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2019
Estimated Enrollment :
54 Patients enrolled
Trial Details
Trial ID
NCT02209428
Start Date
June 1 2014
End Date
May 1 2019
Last Update
February 21 2019
Active Locations (1)
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1
Huashan Hospital Affiliated to Fudan University
Shanghai, Shanghai Municipality, China, 200040