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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03507244|
Recruitment Status : Recruiting
First Posted : April 25, 2018
Last Update Posted : April 26, 2018
|Condition or disease||Intervention/treatment||Phase|
|Leptomeningeal Metastasis||Drug: Pemetrexed Drug: Dexamethasone Radiation: Radiotherapy||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 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|
|Estimated Primary Completion Date :||May 31, 2019|
|Estimated Study Completion Date :||December 31, 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 3.0). 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 clinical response rate will be determined based on the evaluation criteria which have been established and published on the previous paper by the investigators (Pan Z, et al. Int J Cancer. 2016;139:1864-72). This evaluation criteria were mainly based on two factors, including improvement of neurologic symptoms/signs and changes of Karnofsky Performance Status.
- Neurological progression-free survival [ Time Frame: The evaluation was performed at 3 months after the end of treatment or when patient died. ]The neurological progression-free survival is defined as the time elapsed between treatment initiation and neurological progression. The neurological progression was determined based on the evaluation criteria which have been established and published on the previous paper by the investigators (Pan Z, et al. Int J Cancer. 2016;139:1864-72). This criteria was mainly based on the evaluation of neurologic symptoms/signs.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03507244
|Contact: Zhenyu Pan, Professorfirstname.lastname@example.org|
|Contact: Guozi Yang, Professoremail@example.com|
|The First Hospital of Jilin University||Recruiting|
|Changchun, Jilin, China, 130021|
|Contact: Zhenyu Pan, Professor +8615804302753 firstname.lastname@example.org|
|Contact: Guozi Yang, Professor +8615804302755 email@example.com|
|Principal Investigator:||Zhenyu Pan, Professor||First Hospital of Jilin University|