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NCT Number: NCT03082144

Concurrent Involved-field Radiotherapy and Intrathecal Chemotherapy for Leptomeningeal Metastases From Solid Tumors

It has been proved that concurrent radiotherapy (RT) and intrathecal methotrexate (MTX) for leptomeningeal metastases (LM) from solid tumors with adverse prognostic factors showed great effectiveness and safety. Cytarabine(Ara-C) is another agent which is commonly used for intrathecal chemotherapy. The purpose of the study is to observe the effectiveness and safety of concurrent RT and intrathecal chemotherapy for LM from solid tumors. In addition, the effectiveness of these two types of agents (MTX and Ara-C) in the concurrent chemo-radiotherapy will be compared in this study. This is a randomized controlled, parallel group, and phase II clinical trial. The object of this study is newly diagnosis patients with leptomeningeal metastases from solid tumors, who will accept the treatment of involved-field RT combined with concurrent intrathecal-MTX or intrathecal-Ara-C, respectively. Major endpoint is clinical response rate. Secondary endpoints are time to progression,severe adverse events and overall survival.

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Key information

Conditions

Leptomeningeal Metastasis Central Nervous System Neoplasms Meningeal Carcinomatosis Meningeal Neoplasms Neoplasms Neoplasms by Site Nervous System Diseases Nervous System Neoplasms

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

The First Hospital of Jilin University

Changchun, Jilin, 130021, China

About this study

The patients were randomly divided into two groups, who will accept the treatment of involved-field RT combined with concurrent intrathecal-MTX or intrathecal-Ara-C, respectively. Concomitant regimen consisted of intrathecal chemotherapy (via lumbar puncture, MTX 15 mg, plus dexamethasone 5 mg, or Ara-C 50mg, plus dexamethasone 5 mg, once per week, 4 weeks in total) and RT. RT 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 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 RANO proposal for response criteria of LM disease was used to assess the clinical response in this study.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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;
  • No history of severe nervous system disease;
  • No severe dyscrasia;
  • Signed informed consent form.

Exclusion criteria

  • 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.

Treatment and study plan

MTX

Drug

MTX 15 mg,via lumbar puncture,once per week, 4 weeks in total

Other names: Intrathecal chemotherapy

Ara-C

Drug

Ara-C 50mg,via lumbar puncture,once per week, 4 weeks in total

Other names: Intrathecal chemotherapy

Radiotherapy

Radiation

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.

Primary outcomes

  1. Clinical Response Rate (CRR)

    Time frame: The evaluation was performed once per week from the beginning of LM-related therapy, till 4 weeks later after concomitant therapy.

    The RANO proposal for response criteria of LM disease was used to assess the clinical response in this study.

Secondary outcomes

  1. Incidence of severe adverse events (SAE)

    Time frame: At least 7 months after LM diagnosis or until death.

    Adverse events (AEs) were evaluated according to the Common Terminology Criteria for Adverse Events (CTCAE, version 4.03). Events of grade 3-5 was defined as moderate and severe adverse events.

  2. Overall survival(OS)

    Time frame: At least 7 months after LM 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.

Sponsors and collaborators

Lead sponsor

The First Hospital of Jilin University

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Mar 17, 2017
Registry last updated
Aug 1, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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