NCT01656980

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
236

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Aug 2012

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 1, 2012

Completed
Same day until next milestone

Study Start

First participant enrolled

August 1, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 3, 2012

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2014

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
Last Updated

August 3, 2012

Status Verified

August 1, 2012

Enrollment Period

2 years

First QC Date

August 1, 2012

Last Update Submit

August 2, 2012

Conditions

Anaplastic AstrocytomaAnaplastic OligodendrogliomaAnaplastic OligoastrocytomaGlioblastoma

Outcome Measures

Primary Outcomes (1)

  • Overall Survival

    15 months

Secondary Outcomes (5)

  • Progress Free Survival

    15 months

  • Overall Survival Rate at 12 months

    15 months

  • Karnofsky Performance Status(KPS)

    15 months

  • Quality of Life(QOL)

    15 months

  • Safety of intracranially implanted carmustine after maximal tumor resection

    15 months

Study Arms (2)

Carmustine Sustained Release Implant

EXPERIMENTAL

For subjects in this group, they will accept intracranially implanted carmustine intraoperatively.

Drug: Carmustine

Tumor Resection Surgery

SHAM COMPARATOR

For subjects in this control group, they accept no implants while gliomas maximally be resected.

Procedure: tumor resection surgery

Interventions

CarmustineDRUG

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

Also known as: Trade name: CASANT, Other name: BCNU
Carmustine Sustained Release Implant
tumor resection surgeryPROCEDURE

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

Also known as: blank control group
Tumor Resection Surgery

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Confirmation of high grade glioma(WHO III or above)by frozen or squash preparation;
  • Patients must be 18 to 70 years old, signed ICF;
  • At least 4 weeks after previous chemotherapy (6 weeks since nitrosoureas);
  • KPS ≥ 60;
  • Unilateral, Supratentorial, solitary lesion and not crossing the midline
  • No obvious important organ dysfunction: Hepatic function:Serum total bilirubin ≤1.5 times upper limit of laboratory normal; Aspartate aminotransferase (AST) and/or Alanine aminotransferase (ALT)\<2.5 times upper limit of laboratory normal; Renal function:Serum creatinine ≤1.5 times upper limit of laboratory normal;
  • Not Pregnant or lactating for women of childbearing potential.

You may not qualify if:

  • Underwent cytoreductive surgery(excluded stereotactic biopsy);
  • With chemotherapy or brain radiotherapy history;
  • Tumor located at ventricular system, Open ventricle tumor cavity postoperatively;
  • Concomitant with other life-threatening diseases and with life expectancy \<12 months;
  • Allergic to nitrosourea drugs;
  • With history of intracranial radiotherapy or implant chemotherapy;
  • With serious cardiac, pulmonary, hepatic and renal dysfunction, poor glycemic control;
  • Experienced \> 3 times of Large epilepsy within one month preoperatively.
  • Investigators thought unsuitable for enrollment.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Beijing Tiantan Hospital Affiliated to Capital Medical University

Beijing, Beijing Municipality, 100050, China

Location

Related Links

MeSH Terms

Conditions

AstrocytomaOligodendrogliomaGlioblastoma

Interventions

Carmustine

Condition Hierarchy (Ancestors)

GliomaNeoplasms, NeuroepithelialNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasmsNeoplasms, Glandular and EpithelialNeoplasms, Nerve Tissue

Intervention Hierarchy (Ancestors)

Nitrosourea CompoundsUreaAmidesOrganic ChemicalsNitroso Compounds

Study Officials

  • Yan H Sun, M.D.

    Beijing Tiantan Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Yan H Sun, M.D.

CONTACT

+86-1360-1389-945sunyanhui1109@yahoo.com.cn

Jian J Yu, Master

CONTACT

+86-15336402751yujj@lanjin.cn

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 1, 2012

First Posted

August 3, 2012

Study Start

August 1, 2012

Primary Completion

August 1, 2014

Study Completion

December 1, 2014

Last Updated

August 3, 2012

Record last verified: 2012-08

Locations

CN(1)