Concurrent Intrathecal-pemetrexed and Involved-field Radiotherapy for Leptomeningeal Metastasis From Solid Tumors
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03507244|
Recruitment Status : Completed
First Posted : April 25, 2018
Last Update Posted : December 26, 2019
|Condition or disease||Intervention/treatment||Phase|
|Leptomeningeal Metastasis||Drug: Pemetrexed Drug: Dexamethasone Radiation: Radiotherapy||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||34 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Intrathecal-pemetrexed Combined With Concurrent Involved-field Radiotherapy for Leptomeningeal Metastasis From Solid Tumor: a Phase I/II Clinical Trial|
|Actual Study Start Date :||April 12, 2018|
|Actual Primary Completion Date :||January 15, 2019|
|Actual Study Completion Date :||July 30, 2019|
Experimental: Group 1,Intra-pemetrexed, radiotherapy
The treatment regimen consisted of intrathecal chemotherapy (via lumbar puncture, pemetrexed 10 mg, plus dexamethasone 5 mg, once per week, 5-8 times, 4-7 weeks in total) and radiotherapy. Radiotherapy consisted of fractionated, conformal radiation given at a daily dose of 2 Gy. The planning volume consisted of sites of symptomatic disease, bulky disease observed on magnetic resonance imaging, including the whole brain and basis cranii received 40 Gy in 20 fractions, 4 weeks in total, and/or segment of spinal canal received 40-50 Gy.
Pemetrexed, 10 mg,intrathecal injection, plus dexamethasone 5 mg, once per week, 5 to 8 times, 4 to 7 weeks in total.
Dexamethasone, 5 mg, intrathecal injection, simultaneously with pemetrexed, once per week, 5 to 8 times, 4 to 7 weeks in total.
The sites of symptomatic disease, bulky disease observed on MRI, including the whole brain and basis cranii, 40 Gy in 20 fractions;and/or segment of spinal canal received 40-50 Gy in 20-25 fractions.
- Incidence of treatment-related adverse events [ Time Frame: The evaluation was performed at 3 months after the end of treatment or when patient died. ]The incidence of treatment-related adverse events were measured for determing tolerability and safety. Adverse events (AEs) are evaluated according to the Common Terminology Criteria for Adverse Events (CTCAE, version 4.03). Events of grade 3-5 are defined as moderate and severe adverse events.
- Clinical response rate [ Time Frame: The evaluation was performed at 3 months after the end of treatment or when patient died. ]The RANO proposal for response criteria of leptomeningeal metastasis was used to assess the clinical response in this study.
- Overall survival [ Time Frame: The evaluation was performed at least 7 months after leptomeningeal metastasis diagnosis or until death. ]Survival time was recorded since the date of patient enrollment. All patients were followed up until death or the end of the study.
- Neurological progression-free survival (NPFS) [ Time Frame: All patients were followed up at least 6 months, and the evaluation of NPFS was performed from the beginning of treatment until the date of first documented neurological progression or date of death from any cause, whichever came first. ]NPFS was defined as time from the start of treatment until neurological progression or death. The neurological progression was determined based on the RANO proposal evaluation criteria which have been established and published on Neuro Oncol.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03507244
|The First Hospital of Jilin University|
|Changchun, Jilin, China, 130021|
|Principal Investigator:||Zhenyu Pan, Professor||The First Hospital of Jilin University|