NCT03082144

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

Completed Phase 2 Last updated 1 August 2019

What this trial tests

Phase 2 trial testing MTX in Leptomeningeal Metastasis in 53 participants. Completed in 30 December 2018.

Timeline

1 February 2017

Primary endpoint
30 May 2018

30 December 2018

Quick facts

Lead sponsor	The First Hospital of Jilin University
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	53
Start date	1 February 2017
Primary completion	30 May 2018
Estimated completion	30 December 2018
Sites	1 location across China

Drugs / interventions tested

• MTX — full drug profile →
• Ara-C — full drug profile →
• Radiotherapy — full drug profile →

Conditions studied

• Leptomeningeal Metastasis — all drugs for Leptomeningeal Metastasis →

Sponsor

The First Hospital of Jilin University

Who can join

Adults 18 to 75, any sex, with Leptomeningeal Metastasis. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Radiotherapy in Leptomeningeal Disease: A Systematic Review of Randomized and Non-randomized Trials.
   Buszek SM, Chung C. · · 2019 · cited 43× · PMID 31803614 · DOI 10.3389/fonc.2019.01224
2. Identification of Cerebrospinal Fluid MicroRNAs Associated With Leptomeningeal Metastasis From Lung Adenocarcinoma.
   Pan Z, Yang G, He H, Gao P, et al · · 2020 · cited 16× · PMID 32328453 · DOI 10.3389/fonc.2020.00387
3. Radiotherapy for Leptomeningeal Carcinomatosis in Breast Cancer Patients: A Narrative Review.
   Pawłowska E, Romanowska A, Jassem J. · · 2022 · cited 5× · PMID 36010893 · DOI 10.3390/cancers14163899
4. CTNI-13. CONCURRENT INTRATHECAL CHEMOTHERAPY AND INVOLVED-FIELD RADIOTHERAPY FOR LEPTOMENINGEAL METASTASIS FROM SOLID TUMORS: A PHASE II STUDY (NCT03082144)
   · 2023
5. CTNI-12. GENOMIC ANALYSIS OF HUMAN BRAIN METASTASES TREATED WITH STEREOTACTIC RADIOSURGERY UNDER THE PHASE-II CLINICAL TRIAL (NCT03398694) REVEALS DNA DAMAGE REPAIR AT THE PERIPHERAL TUMOR EDGE
   · 2023
6. CTNI-10. SACITUZUMAB GOVITECAN FOR BREAST CANCER BRAIN METASTASIS
   · 2023
7. CTNI-11. THE VALUE OF STEREOTACTIC BIOPSY OF PRIMARY AND RECURRENT BRAIN METASTASES IN THE ERA OFPRECISION MEDICINE
   · 2023
8. CTNI-09. DOSE ESCALATION FOR NEOADJUVANT STEREOTACTIC RADIOSURGERY FOR LARGE BRAIN METASTASES: PHASE I RESULTS
   · 2023