search
Back to results

Prophylactic Cranial Irradiation in Erlotinib/Gefitinib-responders With Non-small Cell Lung Cancer (NSCLC) (RT1001)

Primary Purpose

Non-small Cell Lung Cancer

Status
Unknown status
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
Prophylactic cranial irradiation
Erlotinib /Gefitinib
Sponsored by
Zhejiang Cancer Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Non-small Cell Lung Cancer focused on measuring nonsmall cell lung cancer, brain metastasis, prophylactic cranial irradiation

Eligibility Criteria

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

Inclusion Criteria:

  1. Patients were required to have histologically or cytologically documented
  2. NSCLC and no brain metastasis documented by magnetic resonance imaging (MRI)within 21 days after confirmed response (RR+SD) to chemotherapy
  3. No previous history of radiotherapy and surgery of brain
  4. good response( CR/PR) to Erlotinib or Gefitinib.
  5. Agree to radiotherapy
  6. age > 18 and <75 years,ECOG performance status 1 or less
  7. Good renal and hepatic and haematological (absolute neutrophils count 15 x1O9/L and platelet count 90 x 109/L,HB>=80g /DL) functions
  8. Have provided informed consent

Exclusion Criteria:

  1. Seizure cannot be controled by the drugs
  2. Combined with other disease of the brain such as tumour or infarction
  3. Hypersensitivity to MR enhancer -

Sites / Locations

  • Zhejiang Cancer HospitalRecruiting
  • Zhejiang Cancer HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

prophylactic cranial irradiation

Conctrol

Arm Description

Patients receive Erlotinib or gefitinib until disease progression or intolerable toxicity, and prophylactic cranial irradiation 25GY over 10 fractions.

Patients received Erlotinib or gefitinib until disease progression,or intolerable toxicity

Outcomes

Primary Outcome Measures

The primary endpoint is the cumulative incidence of symptomatic brain metastases (BM)

Secondary Outcome Measures

overall survival

Full Information

First Posted
June 23, 2010
Last Updated
July 6, 2010
Sponsor
Zhejiang Cancer Hospital
search

1. Study Identification

Unique Protocol Identification Number
NCT01158170
Brief Title
Prophylactic Cranial Irradiation in Erlotinib/Gefitinib-responders With Non-small Cell Lung Cancer (NSCLC) (RT1001)
Official Title
A Randomized, Phase III Trial of Prophylactic Cranial Irradiation (PCI) in Patients With Advanced Non-small Cell Lung Cancer (NSCLC) Who Are Effective on Erlotinib or Gefitinib(RT1001)
Study Type
Interventional

2. Study Status

Record Verification Date
July 2010
Overall Recruitment Status
Unknown status
Study Start Date
June 2010 (undefined)
Primary Completion Date
May 2013 (Anticipated)
Study Completion Date
December 2013 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Zhejiang Cancer Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
RATIONALE: Radiation therapy to the brain may be effective in preventing brain metastases in patients with advanced non-small cell lung cancer. It is not yet known whether radiation therapy is more effective than observation in patients with advanced non-small cell lung cancer. PURPOSE: This randomized phase III trial is studying radiation therapy to the brain to see how well it works compared with observation in preventing brain metastases in patients with advanced non-small cell lung cancer
Detailed Description
OBJECTIVES: Primary Determine the effectiveness of prophylactic cranial radiotherapy in patients with advanced non-small cell lung cancer that is responsive to gefitinib or erlotinib hydrochloride. Secondary Determine the progression-free survival in patients treated with this regimen. Determine the overall survival in patients treated with this regimen. Determine the safety and tolerability of this regimen in these patients. Determine the psycho-neurological effects of this regimen in these patients. Determine the quality of life of patients treated with this regimen. OUTLINE: This is a multicenter study. Patients with good response( CR/PR) to EGFR-TKI(Erlotinib or Gefitinib) are randomized to receive EGFR-TKI plus PCI or EGFR-TKI alone,stratified according to prior chemotherapy regimens (first line vs second line), and disease response status. Group 1: Patients undergo prophylactic brain radiotherapy. Group 2: Patients undergo observation. Patients complete quality of life questionnaires periodically. After completion of study therapy, patients are followed up periodically.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-small Cell Lung Cancer
Keywords
nonsmall cell lung cancer, brain metastasis, prophylactic cranial irradiation

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
prophylactic cranial irradiation
Arm Type
Experimental
Arm Description
Patients receive Erlotinib or gefitinib until disease progression or intolerable toxicity, and prophylactic cranial irradiation 25GY over 10 fractions.
Arm Title
Conctrol
Arm Type
Active Comparator
Arm Description
Patients received Erlotinib or gefitinib until disease progression,or intolerable toxicity
Intervention Type
Radiation
Intervention Name(s)
Prophylactic cranial irradiation
Other Intervention Name(s)
PCI
Intervention Description
25GY/10fraction
Intervention Type
Drug
Intervention Name(s)
Erlotinib /Gefitinib
Other Intervention Name(s)
EGFR-TKI
Intervention Description
Erlotinib 150mg/d or Gefitinib 250mg/d until disease progression or intolerable toxicity
Primary Outcome Measure Information:
Title
The primary endpoint is the cumulative incidence of symptomatic brain metastases (BM)
Time Frame
2.5years
Secondary Outcome Measure Information:
Title
overall survival
Time Frame
baseline to date of death from any cause

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: Patients were required to have histologically or cytologically documented NSCLC and no brain metastasis documented by magnetic resonance imaging (MRI)within 21 days after confirmed response (RR+SD) to chemotherapy No previous history of radiotherapy and surgery of brain good response( CR/PR) to Erlotinib or Gefitinib. Agree to radiotherapy age > 18 and <75 years,ECOG performance status 1 or less Good renal and hepatic and haematological (absolute neutrophils count 15 x1O9/L and platelet count 90 x 109/L,HB>=80g /DL) functions Have provided informed consent Exclusion Criteria: Seizure cannot be controled by the drugs Combined with other disease of the brain such as tumour or infarction Hypersensitivity to MR enhancer -
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Shenglin Ma, MD
Phone
+8657188122568
Email
mashenglin@medmail.com.cn
First Name & Middle Initial & Last Name or Official Title & Degree
Yaping Xu, MD
Phone
+8657188122082
Email
xuyaping1207@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shenglin Ma, MD
Organizational Affiliation
Zhejiang Cancer Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Zhejiang Cancer Hospital
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310022
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
XuYa ping, MD
Phone
0086-571-88122082
Email
xuyaping1207@gmail.com
Facility Name
Zhejiang Cancer Hospital
City
Hangzhou
State/Province
Zhejiang
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shenglin MA, MD
Phone
+8657188122568
Email
mashenglin@medmail.com.cn
First Name & Middle Initial & Last Name & Degree
Yaping Xu, MD
Phone
+8657188122082
Email
xuyaping1207@gmail.com

12. IPD Sharing Statement

Learn more about this trial

Prophylactic Cranial Irradiation in Erlotinib/Gefitinib-responders With Non-small Cell Lung Cancer (NSCLC) (RT1001)

We'll reach out to this number within 24 hrs