Completed

Involved-field Radiotherapy with Intrathecal-MTX or Intrathecal-Ara-C for Leptomeningeal Metastases

What is being tested

MTX

+ Radiotherapy

+ Ara-C

DrugRadiation

Who is being recruted

Meningeal Neoplasms+4

+ Neoplasms

+ Neoplasms by Site

From 18 to 75 Years

+11 Eligibility Criteria

See all eligibility criteria

How is the trial designed

Treatment Study

Phase 2

Interventional

Study Start: February 2017

See protocol details

Summary

Principal SponsorThe First Hospital of Jilin University

Last updated: January 27, 2026

Sourced from a government-validated database.Claim as a partner

Study start date: February 1, 2017

Actual date on which the first participant was enrolled.

This is a phase 2 clinical trial that aims to compare two different treatments for leptomeningeal metastases, a condition where cancer from a solid tumor spreads to the thin layers of tissue that cover the brain and spinal cord. The trial involves patients who will receive either involved-field radiotherapy with concurrent intrathecal-MTX or intrathecal-Ara-C. The goal of this study is to find a more effective treatment for this condition, potentially improving care and addressing current challenges faced by patients. During the trial, participants will undergo a combination of radiotherapy and intrathecal chemotherapy. The radiotherapy involves fractionated, conformal radiation given at a daily dose of 2 Gy, targeting sites of symptomatic disease, bulky disease observed on MRI, including the whole brain and basis cranii received 40 Gy in 20 fractions and/or segment of spinal canal received 40-50 Gy. The intrathecal chemotherapy is administered via lumbar puncture, with either MTX 15 mg plus dexamethasone 5 mg, or Ara-C 50mg plus dexamethasone 5 mg, once per week for 4 weeks. The clinical response is assessed using the RANO proposal for response criteria of LM disease.

Official TitleInvolved-field Radiotherapy Combined With Concurrent Intrathecal-MTX Versus Intrathecal-Ara-C for Leptomeningeal Metastases From Solid Tumor: A Randomized Phase II Clinical Trial

NCT03082144

Principal SponsorThe First Hospital of Jilin University

Last updated: January 27, 2026

Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

53 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.

Conditions

Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 75 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Meningeal NeoplasmsNeoplasmsNeoplasms by SiteNervous System DiseasesNervous System NeoplasmsCentral Nervous System NeoplasmsMeningeal Carcinomatosis

Criteria

7 inclusion criteria required to participate

Patients who have been definitely diagnosed as leptomeningeal metastasis according to cerebrospinal fluid cytology or neuroimaging, or patients who got the clinical diagnosis by combining with the history of cancer, clinical manifestation, cerebrospinal fluid examination, neuroimaging etc;

Patients who have been diagnosed as malignant solid tumor with definite pathologic type, excluding hematological malignancies (e.g., leukemia and lymphoma) or primary brain tumors;

No severe abnormal liver and kidney function; WBC≥2500/mm3, Plt≥60000/mm3;

No other severe chronic diseases;

Show More Criteria

4 exclusion criteria prevent from participating

Patients with leptomeningeal metastasis from unknown primary tumor;

Patients who had received radiotherapy to the brain in the past 6 months;

Patients who had accepted systemic chemotherapy within one month before the treatment, or molecular targeted therapy less than 3 months;

Patients with poor compliance, or for other reasons, the researchers considered unsuitable to participate in this clinical study.

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.

Treatment Groups

Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group

Treatment Groups

Group I

Active Comparator

Intrathecal chemotherapy: MTX 15 mg, plus dexamethasone 5 mg, via lumbar puncture,once per week, 4 weeks in total.

Group II

Experimental

Intrathecal chemotherapy:Ara-C 50 mg, plus dexamethasone 5 mg, via lumbar puncture, once per week, 4 weeks in total.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

The First Hospital of Jilin University

Changchun, ChinaOpen The First Hospital of Jilin University in Google Maps

CompletedOne Study Center