The goal of this prospective, single-arm exploratory clinical study is to explore the safty and efficacy of whole-brain radiotherapy combined with Thiotepa intrathecal injection combined with systemic therapy for the primary disease in the treatment of leptoeningeal metastases in solid tumors How works well was the combined therapy? How safe was combined therapy? Participants will continue systemic treatment, receive HA-WBRT combined with intrathecal injection of Thiotepa. Evaluate the efficacy and safety every 6 cycles. Researchers will evaluate whether this combination treatment is safe and whether it is more effective than previous studies.
Participants will receive a comprehensive treatment plan consisting mainly of HA-WBRT combined with intrathecal injection of Thiotepa. All eligible patients received intrathecal injection of Thiotepa twice a week for 1 week as induction treatment for 3 weeks, followed by once every week as consolidation therapy for 6 week and then once monthly as maintenance therapy, until progressive disease was observed or intolerance or adverse events (AEs) developed. The injection was administered by qualified individuals (certified personnel in the radiotherapy department of our hospital) . Thiotepa was injected 10mg each time, mixed with cerebrospinal fluid, and then injected slowly for 5-10 minutes. Evaluate the efficacy and safety every 6 cycles according to RANO-LM criteria.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
58
Participants will receive a comprehensive treatment plan consisting mainly of whole brain 30Gy/10F radiotherapy combined with intrathecal injection of Thiotepa. The injection was administered by qualified individuals (certified personnel in the radiotherapy department of our hospital) twice a week for a total of 4 weeks. Thiotepa was injected 10mg each time, mixed with cerebrospinal fluid, and then injected slowly for 5-10 minutes.
The Second Affiliated Hospital of Zhejiang University
Hangzhou, Zhejiang, China
RECRUITINGIncidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
The primary safety analysis will be conducted based on subjects who experience toxicity (as defined by CTCAE standards). CTCAE version 5.0 will be used to evaluate safety through reported adverse events.
Time frame: 2 years
OS
overall survival
Time frame: 2 years
PFS
progression free survival
Time frame: 2 years
3-month OS
3-month overall survival
Time frame: 3 months
6-month OS
6-month overall survival
Time frame: 6 months
9-month OS
9-month overall survival
Time frame: 9 months
12-month OS
12-month overall survival
Time frame: 12 months
The disease control rate(DCR)
the proportion of patients who, according to internationally recognized criteria for alleviating evaluation, achieve response and stable disease (SD) after treatment and can maintain for the minimum duration requirement.
Time frame: 2 years
The objective response rate (ORR)
The sum of the proportion of responsive patients.
Time frame: 2 years
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