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Temozolomide in Preventing Brain Metastases in Small Cell Lung Cancer

Primary Purpose

Small Cell Lung Cancer, Metastatic Carcinoma

Status
Unknown status
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
temozolomide
prophylaxis cranial radiotherapy
Sponsored by
Guangzhou Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Small Cell Lung Cancer focused on measuring limited small cell lung cancer, brain metastases, prophylactic cranial radiotherapy, temozolomide

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Histological or cytological diagnosis of small-cll lung cancer histology
  2. 18 years or older
  3. Eastern Cooperative Oncology Group (ECOG) Performance Status no more than 2
  4. Local stage SCLC without distant metastases
  5. After 1st-line chemotherapy (EP or IP) at least 4 cycles
  6. After radical radiotherapy for primary tumor and lymph node drainage area:including concurrent or sequence chemoradiotherapy
  7. CR or PR assessment by RECIST(1.0) before randomized
  8. Haemoglobin 10.0 g/dl, Absolute neutrophil count (ANC) 1.5^9/L, platelets 100 x 10^9/L
  9. Total bilirubin 1.5 x upper limit of normal (ULN) alanine aminotransferase (ALT) and aspartate aminotransferase (AST) < 2.5 x ULN in the absence of liver metastases, or < 5 x ULN in case of liver metastases
  10. Creatinine clearance 60ml/min (calculated according to Cockcroft-gault formula)

Exclusion Criteria:

  1. Mixed non-small cell lung cancer histology
  2. Neck and supraclavicular lymph node metastasis
  3. Be allergic to temozolomide or intolerable to radiotherapy
  4. Any unstable systemic disease
  5. Pregnant or lactating women

Sites / Locations

  • The first affiliated hospital of Guangzhou MCRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

temozolomide

prophylaxis cranial radiotherapy

Arm Description

temozolomide oral 150mg/m2 d1-5/28d for 12 cycles

prophylaxis cranial radiotherapy,25-30Gy/10Fra

Outcomes

Primary Outcome Measures

2-year incidence of brain metastases

Secondary Outcome Measures

Full Information

First Posted
November 12, 2015
Last Updated
March 27, 2019
Sponsor
Guangzhou Medical University
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1. Study Identification

Unique Protocol Identification Number
NCT02605811
Brief Title
Temozolomide in Preventing Brain Metastases in Small Cell Lung Cancer
Official Title
Radiation Versus Temozolomide in Preventing Brain Metastases in Limited Stage Small Cell Lung Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
March 2019
Overall Recruitment Status
Unknown status
Study Start Date
September 2015 (undefined)
Primary Completion Date
December 2019 (Anticipated)
Study Completion Date
December 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Guangzhou Medical University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
To investigate the response of temozolomide versus prophylactic cranial radiotherapy in preventing brain metastases in completed or partial remission limited small cell lung cancer patients.
Detailed Description
We'd like to investigate the 2-year incidence rate of brain metastases in completed or partial remission limited small cell lung cancer patients who received temozolomide only for 12 months or 25-30Gy prophylactic cranial radiotherapy in preventing brain metastases.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Small Cell Lung Cancer, Metastatic Carcinoma
Keywords
limited small cell lung cancer, brain metastases, prophylactic cranial radiotherapy, temozolomide

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
426 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
temozolomide
Arm Type
Experimental
Arm Description
temozolomide oral 150mg/m2 d1-5/28d for 12 cycles
Arm Title
prophylaxis cranial radiotherapy
Arm Type
Active Comparator
Arm Description
prophylaxis cranial radiotherapy,25-30Gy/10Fra
Intervention Type
Drug
Intervention Name(s)
temozolomide
Other Intervention Name(s)
Temozolomide Capsules
Intervention Type
Radiation
Intervention Name(s)
prophylaxis cranial radiotherapy
Other Intervention Name(s)
PCI
Intervention Description
2
Primary Outcome Measure Information:
Title
2-year incidence of brain metastases
Time Frame
2 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Histological or cytological diagnosis of small-cll lung cancer histology 18 years or older Eastern Cooperative Oncology Group (ECOG) Performance Status no more than 2 Local stage SCLC without distant metastases After 1st-line chemotherapy (EP or IP) at least 4 cycles After radical radiotherapy for primary tumor and lymph node drainage area:including concurrent or sequence chemoradiotherapy CR or PR assessment by RECIST(1.0) before randomized Haemoglobin 10.0 g/dl, Absolute neutrophil count (ANC) 1.5^9/L, platelets 100 x 10^9/L Total bilirubin 1.5 x upper limit of normal (ULN) alanine aminotransferase (ALT) and aspartate aminotransferase (AST) < 2.5 x ULN in the absence of liver metastases, or < 5 x ULN in case of liver metastases Creatinine clearance 60ml/min (calculated according to Cockcroft-gault formula) Exclusion Criteria: Mixed non-small cell lung cancer histology Neck and supraclavicular lymph node metastasis Be allergic to temozolomide or intolerable to radiotherapy Any unstable systemic disease Pregnant or lactating women
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Haihong Yang, MD
Phone
862083062825
Email
bjrf2009@yahoo.com
First Name & Middle Initial & Last Name or Official Title & Degree
Haihng Yang, MD
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hailing Yang, MD
Organizational Affiliation
the first affiliated hospital of Guangzhou MC
Official's Role
Principal Investigator
Facility Information:
Facility Name
The first affiliated hospital of Guangzhou MC
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510120
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Haihong Yang, Dr.
Phone
0862083062825
Email
bjrf2009@yahoo.com
First Name & Middle Initial & Last Name & Degree
Haihong Yang, Dr.

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Temozolomide in Preventing Brain Metastases in Small Cell Lung Cancer

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