A Study on β-elemene as Maintain Treatment for Newly Diag... | NCT02629757

Studies
A Study on β-elemene as Maintain Treatment for Newly Diagnosed Malignant Gliomas

NCT02629757

Sponsor

Sun Yat-sen University

Status

Unknown status

Last Update Posted

Feb 23, 2018Actual

Enrollment

100Estimated

Phase

Phase 3

Conditions

Anaplastic Oligoastrocytoma
Anaplastic Astrocytoma
Glioblastoma

Interventions

β-elemene

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2018

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2015

Primary Completion Date

Apr 2020Estimated

Completion Date

May 2023Estimated

First Submitted Date

Dec 10, 2015

First Submission Date that Met QC Criteria

Dec 11, 2015

First Posted Date

Dec 14, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 21, 2018

Last Update Posted Date

Feb 23, 2018Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

This study is being conducted to help determine whether β-elemene as maintain treatment for complete remission patients of newly diagnosed malignant gliomas following standard treatment, is able to delay tumor growth, or impact how long people with newly diagnosed high-grade glioma.

Detailed Description

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

100Estimated

Label	Type	Description	Intervention Names
β-elemene	Experimental	β-elemene 600mg/d,ivdrip,d1-14,every 28 days for 1 cycle, totally 6 cycles.	Drug: β-elemene

Name	Type	Description	Arm Group Labels	Other Names
β-elemene	Drug	β-elemene 600mg/d,ivdrip,d1-14,every 28 days for 1 cycle, totally 6 cycles	β-elemene

Measure	Description	Time Frame
Over-all survival		5-year

Measure	Description	Time Frame
Quality of life		5-year

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

- Page 3 of 4 [DRAFT] - Arms Assigned Interventions
- Temodar Experimental: temozolomide +α-IFN Four weeks after radiotherapy, patients will be received 6 cycle of temozolomide plus α-IFN α-IFN： 3mIU (3million) Day1,3,5 of each 28 day TMZ：150 mg/m^2 daily on Days 2-6 of each 28 day study cycle and 200 mg/m^2 daily of subsequent cycles Drug: Temozolomide dosed at 200 mg/m2 (150 mg/m2 for the first cycle) daily for 5 consecutive days, repeated every 28 days

Other Names:

• Temodar Drug: α-IFN 3mIU (3million) D1，3，5

Other Names:

Minimum Age: 18 Years Maximum Age: 75 Years Gender: Both Accepts Healthy Volunteers?: No

Criteria: Inclusion Criteria:

Age: 18 years to 75 years
complete remission patients of newly diagnosed WHO III-IV glioma following standard treatment
Karnofsky Performance Score ≥ 60
Adequate bone marrow, liver and renal function
Ability of subject to understand character and individual consequences of the clinical trial
Written informed consent
anticipating survival ≥2 months

Exclusion Criteria:

Refusal to participate the study
Known hypersensitivity or contraindication to temozolomide
Incompletely radiation
Pregnant or lactating females
Malignant tumor other than brain tumor
Contraindicated for MRI examination
Unable to comply with the follow-up studies of this trial
Purulent and chronic infected wounds
Uncontrolled psychotic disorders or epilepsy
progression disease

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Role	Phone	Extension	Email
Zhong-ping CHEN	Contact	+86-20-87343310		chenzhp@sysucc.org.cn
Chengceng Guo	Contact	+86-20-87343890		guochch@sysucc.org.cn

ID	Term
D018302	Neoplasms, Neuroepithelial
D017599	Neuroectodermal Tumors
D009373	Neoplasms, Germ Cell and Embryonal
D009370	Neoplasms by Histologic Type

ID	Term
D001254	Astrocytoma
D005909	Glioblastoma
D005910	Glioma