Temozolomide and Concomitant Whole Brain Radiotherapy in... | NCT02385136

Studies
Temozolomide and Concomitant Whole Brain Radiotherapy in NSCLC Patients With Brain Metastases

NCT02385136

Sponsor

Zhejiang Cancer Hospital

Status

Unknown status

Last Update Posted

Mar 11, 2015Estimated

Enrollment

135Estimated

Phase

Phase 1Phase 2

Conditions

NSCLC

Interventions

Temozolomide

Countries

Not provided

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

Mar 2015

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2015

Primary Completion Date

Dec 2016Estimated

Completion Date

Dec 2018Estimated

First Submitted Date

Mar 3, 2015

First Submission Date that Met QC Criteria

Mar 10, 2015

First Posted Date

Mar 11, 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

Mar 10, 2015

Last Update Posted Date

Mar 11, 2015Estimated

Name	Class
Hangzhou Cancer Hospital	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

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

The purpose of this study is to evaluate the safety profile and efficacy of whole brain radiotherapy (WBRT) concomitantly with temozolomide (TMZ) in patients with brain metastases (BM).Patients with BM were randomly assigned to 30 Gy of WBRT with or without concomitant TMZ (75 mg/m2/d) plus two cycles of TMZ (200 mg/m2/d for 5 days).

Detailed Description

Not provided

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 1Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

135Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
WBRT plus TMZ arm	Experimental	whole brain radiotherapy (WBRT) concomitantly with temozolomide (TMZ)	Drug: Temozolomide
WBRT	No Intervention	whole brain radiotherapy (WBRT)

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Temozolomide	Drug		WBRT plus TMZ arm

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
objective response rate		1 month post procedure
Time to central nervous system progress which was confirmed by MRI		1 to 24 months post procedure

Secondary Outcomes

Measure	Description	Time Frame
The Quality of Life		0 to 24 months post procedure
Overall Survival		1 to 24 months post procedure
Toxicity as measured by CTCAE V4.0

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

histologically diagnosed as NSCLC, stage IVb [ (American Joint of Cancer Committee(AJCC), 2002) ], Brain metastasis
no history of hypertension or diabetes.

Exclusion Criteria:

the brain tumor diameter >5cm; RPA class =3; pregnancy.

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

Intervention Browse Module

MeSH Terms

ID	Term
D000077204	Temozolomide

Ancestor Terms

ID	Term
D003606	Dacarbazine
D014226	Triazenes
D009930	Organic Chemicals
D007093	Imidazoles

Browse Leaves

Not provided

Browse Branches

Not provided