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Safety and Efficacy Study of Intracranially Implanted Carmustine to Treat Newly Diagnosed Malignant Glioma

NCT01656980 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 236

Last updated 2012-08-03

No results posted yet for this study

Summary

The purpose of the study is to determine the safety and efficacy of intracranially implanted Carmustine in the treatment of patients with primary malignant glioma.

Conditions

  • Anaplastic Astrocytoma
  • Anaplastic Oligodendroglioma
  • Anaplastic Oligoastrocytoma
  • Glioblastoma

Interventions

DRUG

Carmustine

As Experimental group, subjects will accept specified wafers of carmustine in the cavity while gliomas maximally be resected.

PROCEDURE

tumor resection surgery

For this group, subjects will accept routine tumor resection surgery and place no implant wafers.

Sponsors & Collaborators

  • Shandong Lanjin Pharmaceuticals Co.,Ltd

    lead INDUSTRY

Principal Investigators

  • Yan H Sun, M.D. · Beijing Tiantan Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-08-31
Primary Completion
2014-08-31
Completion
2014-12-31

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01656980 on ClinicalTrials.gov