Temozolomide and Concomitant Whole Brain Radiotherapy in NSCLC Patients With Brain Metastases
Sponsor
Zhejiang Cancer Hospital (Other)
Overall Status
Unknown status
CT.gov ID
NCT02385136
Collaborator
Hangzhou Cancer Hospital (Other)
135
2
44
Study Details
Study Description
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).
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 1/Phase 2 |
Study Design
Study Type:
Interventional
Anticipated Enrollment
:
135 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Prevention
Official Title:
Temozolomide and Concomitant Whole Brain Radiotherapy in NSCLC Patients With Brain Metastases: A Randomized Trial
Study Start Date
:
Apr 1, 2015
Anticipated Primary Completion Date
:
Dec 1, 2016
Anticipated Study Completion Date
:
Dec 1, 2018
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: WBRT plus TMZ arm whole brain radiotherapy (WBRT) concomitantly with temozolomide (TMZ) |
Drug: Temozolomide
|
| No Intervention: WBRT whole brain radiotherapy (WBRT) |
Outcome Measures
Primary Outcome Measures
- 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 Outcome Measures
- 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 [0 to 24 months post procedure]
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
to 75 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Zhejiang Cancer Hospital
- Hangzhou Cancer Hospital
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
chenjianxiang,
Dr Chen,
Zhejiang Cancer Hospital
ClinicalTrials.gov Identifier:
NCT02385136
Other Study ID Numbers:
- zjzlyy 2015-1-5
First Posted:
Mar 11, 2015
Last Update Posted:
Mar 11, 2015
Last Verified:
Mar 1, 2015
Keywords provided by chenjianxiang,
Dr Chen,
Zhejiang Cancer Hospital
Additional relevant MeSH terms: