Back to resultsA Study of Pemetrexed Plus Carboplatin Combined With Radiation in Patients With Inoperable Locally Advanced Non-small Cell Lung Cancer (LA-NSCLC) (RT0801) (NSCLC)
Primary Purpose
Non-Small Cell Lung Cancer
Status
Unknown status
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
pemetrexed
carboplatin
thoracic radiation
Sponsored by
About this trial
This is an interventional treatment trial for Non-Small Cell Lung Cancer focused on measuring Non-Small Cell Lung Cancer, pemetrexed, radiation
Eligibility Criteria
Inclusion Criteria:
- Histologically proven non-small cell lung cancer (non-squamous cell carcinoma)
- Presence of measurable disease by RECIST
- Inoperable stage IIIA or IIIB
- ECOG performance status 0-1
- No prior chemotherapy, radiation therapy to chest, immunotherapy, or biologic therapy
- Patients must sign an informed consent indicating that they are aware of the investigational nature of the study in keeping with the policy of the hospital.
Exclusion Criteria:
- Carcinoid tumor, small cell carcinoma of lung
- Patients with any distant metastasis
- History of another malignancy within the last five years except cured basal cell carcinoma of skin and cured carcinoma in-situ of uterine cervix Any other morbidity or situation with contraindication for chemotherapy (e.g. active infection, myocardial infarction preceding 6 months, symptomatic heart disease including unstable angina, congestive heart failure or uncontrolled arrhythmias, immunosuppressive treatment)
- Pregnant or lactating women, women who has not taken test of pregnancy (within 14 days before the first administration) and pregnant women
- Women and men of childbearing potential who have no willing of employing adequate contraception
Sites / Locations
- Zhejiang Cancer Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
1
Arm Description
patients receiving pemetrexed, carboplatin and radiation therapy.
Outcomes
Primary Outcome Measures
tumor response rate
Secondary Outcome Measures
overall survival
time to progressive disease
the safety profile
site of first failure in patients who develop progressive disease
Full Information
NCT ID
NCT00886678
First Posted
March 31, 2009
Last Updated
February 23, 2011
Sponsor
Zhejiang Cancer Hospital
1. Study Identification
Unique Protocol Identification Number
NCT00886678
Brief Title
A Study of Pemetrexed Plus Carboplatin Combined With Radiation in Patients With Inoperable Locally Advanced Non-small Cell Lung Cancer (LA-NSCLC) (RT0801)
Acronym
NSCLC
Official Title
A Phase II Study of Pemetrexed Plus Carboplatin Combined With Radiation in Patients With Inoperable Locally Advanced Non-small Cell Lung Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
March 2010
Overall Recruitment Status
Unknown status
Study Start Date
July 2008 (undefined)
Primary Completion Date
July 2010 (Anticipated)
Study Completion Date
July 2010 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
Zhejiang Cancer Hospital
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Patients with inoperable Non-Small-Cell Lung Cancer will receive thoracic radiation therapy 66 Gy over 33 fractions,and concurrent with 2 cycles of chemotherapy with pemetrexed (500 mg/m2,d1,repeated every 3 weeks)and carboplatin (AUC=5,d1,repeated every 3 weeks).
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
Non-Small Cell Lung Cancer, pemetrexed, radiation
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
63 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
patients receiving pemetrexed, carboplatin and radiation therapy.
Intervention Type
Drug
Intervention Name(s)
pemetrexed
Intervention Description
500 mg/m2, IV, q 21 days x 2 cycles
Intervention Type
Drug
Intervention Name(s)
carboplatin
Intervention Description
AUC=5,IV,q 21 days x 2 cycles
Intervention Type
Radiation
Intervention Name(s)
thoracic radiation
Intervention Description
66 Gy over 33 fractions
Primary Outcome Measure Information:
Title
tumor response rate
Time Frame
Tumor assessments after completion of chemoradiotherapy and every 2 months
Secondary Outcome Measure Information:
Title
overall survival
Time Frame
baseline to date of death from any cause
Title
time to progressive disease
Time Frame
baseline to measured progressive disease
Title
the safety profile
Time Frame
every cycle
Title
site of first failure in patients who develop progressive disease
Time Frame
baseline to measured progressive disease
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Histologically proven non-small cell lung cancer (non-squamous cell carcinoma)
Presence of measurable disease by RECIST
Inoperable stage IIIA or IIIB
ECOG performance status 0-1
No prior chemotherapy, radiation therapy to chest, immunotherapy, or biologic therapy
Patients must sign an informed consent indicating that they are aware of the investigational nature of the study in keeping with the policy of the hospital.
Exclusion Criteria:
Carcinoid tumor, small cell carcinoma of lung
Patients with any distant metastasis
History of another malignancy within the last five years except cured basal cell carcinoma of skin and cured carcinoma in-situ of uterine cervix Any other morbidity or situation with contraindication for chemotherapy (e.g. active infection, myocardial infarction preceding 6 months, symptomatic heart disease including unstable angina, congestive heart failure or uncontrolled arrhythmias, immunosuppressive treatment)
Pregnant or lactating women, women who has not taken test of pregnancy (within 14 days before the first administration) and pregnant women
Women and men of childbearing potential who have no willing of employing adequate contraception
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ma Sheng lin, 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
12. IPD Sharing Statement
Learn more about this trial
A Study of Pemetrexed Plus Carboplatin Combined With Radiation in Patients With Inoperable Locally Advanced Non-small Cell Lung Cancer (LA-NSCLC) (RT0801)
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