A Prospective Cohort to Study the Effect of Temozolomide on IDH Mutational Low Grade Gliomas

• Status: Unknown status
• Trial end date: 2019-05-01
• Target enrollment: 0
• Participant gender: All

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 patients. For patients with tumor located in eloquent areas so that gross total resection is not applicable, National Comprehensive Cancer Network (NCCN) 2013 guidelines assigned both radiotherapy or chemotherapy as adjuvant treatments of low grade glioma following surgeries. Retrospective studies have suggested that temozolomide (an oral chemotherapeutics) chemotherapy have good effects on the control of tumor progression or recurrence in LGG patients after surgeries, especially in those with isocitrate dehydrogenase (IDH) gene mutations.

Therefore, our prospective cohort study is to provide a higher level(IIb) of evidence for the correlation between IDH mutation and the responsiveness to up-front adjuvant metronomic temozolomide chemotherapy in young patients with LGG located in eloquent brain areas. And hopefully justify future RCTs with comparison between effects of adjuvant radiotherapy and chemotherapy in these patients.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Huashan Hospital
• Treatments: Dacarbazine; Temozolomide

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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.