Ignite Creation Date:
2024-05-05 @ 12:01 PM
Last Modification Date:
2024-10-26 @ 9:19 AM
Study NCT ID:
NCT00216125
Status:
COMPLETED
Last Update Posted:
2016-03-16
First Post:
2005-09-12
Brief Title:
CisplatinEtoposideRadiotherapy - Consolidation Docetaxel in Advanced Stage III Non-Small Cell Lung Cancer
Sponsor:
Nasser Hanna MD
Organization:
Hoosier Cancer Research Network
Study Overview
Official Title:
A Phase III Trial of CisplatinEtoposideRadiotherapy With or Without Consolidation Docetaxel in Patients With Inoperable Locally Advanced Stage III Non-Small Cell Lung Cancer NSCLC Hoosier Oncology Group LUN01-24
Status:
COMPLETED
Status Verified Date:
2016-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
In a previous phase II study patients with pathological stage IIIb without pleural effusion NSCLC were treated with concurrent cisplatin and etoposide plus thoracic radiotherapy followed by 3 cycles of consolidation therapy with docetaxel Docetaxel was selected based upon a survival benefit in patients with recurrent NSCLC
This trial will evaluate the role of consolidation therapy with docetaxel in patients with unresectable stage III disease The purpose of the trial is to evaluate survival and toxicities of the regimens employed
This trial will evaluate the role of consolidation therapy with docetaxel in patients with unresectable stage III disease The purpose of the trial is to evaluate survival and toxicities of the regimens employed
Detailed Description:
OUTLINE This is a multi-center study
Cisplatin 50 mgm2 d1 8 29 36
Etoposide 50 mgm2day d1-5 29-33
Radiation 5940 cGy 180 cGyday
Patients with CR PR SD Randomized to eitherDocetaxel75 mgm2 q3wk X 3 cycles
or Observation Only
Performance Status ECOG 0 or 1
Life Expectancy Not specified
Hematopoietic
ANC 1500mm3
Platelet count 100000mm3
Hemoglobin 8 gdl PRBC transfusions will be allowed to increase hemoglobin to 8 gdl
Hepatic
Serum bilirubin institutional upper limit of normal ULN
AST 25 X the upper limits of normal if alkaline phosphatase is ULN or alkaline phosphatase may be up to 4 X ULN if AST are ULN
Renal
Serum creatinine of 2 mgdl or calculated creatinine clearance 50 ccmin
Cardiovascular
No clinically significant history of cardiac disease ie uncontrolled hypertension unstable angina congestive heart failure myocardial infarction within the past year or cardiac ventricular arrhythmias requiring medication
Pulmonary
Pre-registration FEV1 1 liters by spirometry within 42 days prior to study treatment
Cisplatin 50 mgm2 d1 8 29 36
Etoposide 50 mgm2day d1-5 29-33
Radiation 5940 cGy 180 cGyday
Patients with CR PR SD Randomized to eitherDocetaxel75 mgm2 q3wk X 3 cycles
or Observation Only
Performance Status ECOG 0 or 1
Life Expectancy Not specified
Hematopoietic
ANC 1500mm3
Platelet count 100000mm3
Hemoglobin 8 gdl PRBC transfusions will be allowed to increase hemoglobin to 8 gdl
Hepatic
Serum bilirubin institutional upper limit of normal ULN
AST 25 X the upper limits of normal if alkaline phosphatase is ULN or alkaline phosphatase may be up to 4 X ULN if AST are ULN
Renal
Serum creatinine of 2 mgdl or calculated creatinine clearance 50 ccmin
Cardiovascular
No clinically significant history of cardiac disease ie uncontrolled hypertension unstable angina congestive heart failure myocardial infarction within the past year or cardiac ventricular arrhythmias requiring medication
Pulmonary
Pre-registration FEV1 1 liters by spirometry within 42 days prior to study treatment
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None