Abstract 395TiP
Background
Metastatic brain tumours are the most common intracranial tumours in adults and also the principal cause of death in malignant tumours. Radiotherapy and chemotherapy are the main therapeutic strategies for patients who are inoperable. Temozolomide (TMZ) is a bioavailable alkylating agent able to penetrate the blood-brain barrier and leads to the apoptosis of tumour cell, thus, it has certain effect on intracranial metastases. At present, it has been proved that oral TMZ is safe and effective in the treatment of patients with brain metastases. Clinical studies have also shown that the bioavailability of oral dosage forms reaches 100%, but eating can reduce its’ absorption by nearly 9%. Intravenous injection is often the most effective form of delivery of an agent of interest with sustained efficacy and can reduce the effect of eating on drug absorption. Currently, no relevant study results on TMZ administered by injection in combination with radiotherapy for patients with brain metastases has been reported.
Trial design
In this single arm, prospective, open-label study, 40 patients aged>18 years, with Karnofsky's index of performance status > 60, a histological or cytological diagnosis of primary cancer with brain metastasis who had no previous treatment with TMZ or progressed>6 months after completing TMZ therapy or progressed>1 year after TMZ adjuvant therapy will be enrolled. All patients will receive hypofractionated radiation therapy plus TMZ by injection until progression, intolerable toxicity, death or consent withdrawal. TMZ injections are administered at 75mg/m2 every day starting on the first day of radiotherapy until the last day. The primary endpoint is intracerebral objective response rate (IORR), evaluated according to Response Evaluation Criteria in Solid Tumors, version 1.1 (RECIST 1.1), including objective response at 1, 2, 4 and 6 months after treatment. Secondary endpoints are disease control rate (DCR) according to RECIST 1.1, progression-free survival (PFS) according to RECIST 1.1, quality of life score (QoL) and safety. The study will be followed for up to 1 year after the last administration of the last patient, and this study is ongoing.
Clinical trial identification
ChiCTR1900023653, China.
Editorial acknowledgement
Legal entity responsible for the study
The First Affiliated Hospital of Dalian Medical University.
Funding
Has not received any funding.
Disclosure
All authors have declared no conflicts of interest.