Efficacy Study of Induction Chemotherapy Before Surgery i... | NCT00329472

Studies
Efficacy Study of Induction Chemotherapy Before Surgery in Operable Non-small Cell Lung Cancer

NCT00329472

Sponsor

Samsung Medical Center

Status

Withdrawn

Last Update Posted

Aug 27, 2010Estimated

Enrollment

0Actual

Phase

Phase 3

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

gemcitabine, cisplatin

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2010

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

poor enrollment

Expanded Access Info

Start Date

Apr 2006

Primary Completion Date

Jul 2010Estimated

Completion Date

Jul 2010Estimated

First Submitted Date

May 22, 2006

First Submission Date that Met QC Criteria

May 23, 2006

First Posted Date

May 24, 2006Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 26, 2010

Last Update Posted Date

Aug 27, 2010Estimated

Description Module

Brief Summary

This study is randomized phase III trial designed to assess whether (preoperative) neoadjuvant chemotherapy followed by surgery plus adjuvant chemotherapy with gemcitabine and cisplatin (experimental treatment) improves 3-year disease-free survival, compared to surgery plus adjuvant chemotherapy with gemcitabine and cisplatin (standard treatment) in stage IB, IIA, IIB and T3N1 non-small cell lung cancer

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Gem/Cis	Experimental	neoadjuvant chemotherapy: gemcitabine 1250mg/m2 D1,D8 & cisplatin 70mg/m2 , 2 cycles	Drug: gemcitabine, cisplatin
no neoadjuvant chemotherapy	No Intervention

Interventions

Name	Type	Description	Arm Group Labels	Other Names
gemcitabine, cisplatin	Drug		Gem/Cis

Measure	Description	Time Frame
3-year disease-free survival

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Histologically or cytologically proven NSCLC patients
All patients must have:Clinical stage IB, IIA, IIB and T3N1 by mediastinoscopy, Chest CT and PET-CT
18 year of ages or older
ECOG performance status 0-1
Uni-dimensionally measurable lesion by RECIST criteria
No prior chemotherapy or radiotherapy for NSCLC
Pre-operative FEV1 ≥ 2.0 L evaluated within 28 days
Adequate bone marrow function: Hb > 9.0 g/dL, WBC ≥ 4,000/μL, platelet count ≥ 100,000/μL
Adequate liver and renal function: Total bilirubin < 2 x ULN, AST/ALT < 3 x ULN, serum creatinine ≤ 1.5 mg/dL, creatinine clearance ≥ 60 mL/min
Written informed consent

Exclusion Criteria:

Superior sulcus tumor
Prior malignancy except for adequately treated basal cell or squamous cell skin cancer or in situ cervical cancer at least 5 years
Uncontrolled systemic illness such as DM, CHF, unstable angina or arrhythmia
Recent myocardial infarction within 6 months
Patients with post-obstructive pneumonia or serious infection
Pregnant or nursing women (Women of reproductive potential have to agree to use an effective contraceptive method.)
Patients with psychological problem

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Keunchil Park, M.D.	Samsung Medical Center	Principal Investigator

Condition Browse Module

MeSH Terms

ID	Term
D002289	Carcinoma, Non-Small-Cell Lung

Ancestor Terms

ID	Term
D002283	Carcinoma, Bronchogenic
D001984	Bronchial Neoplasms
D008175	Lung Neoplasms
D012142	Respiratory Tract Neoplasms

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000093542	Gemcitabine
D002945	Cisplatin

Ancestor Terms

ID	Term
D006571	Heterocyclic Compounds
D003841	Deoxycytidine
D003562	Cytidine
D011741	Pyrimidine Nucleosides

Browse Leaves

Not provided

Browse Branches

Not provided

Measure	Description	Time Frame
overall survival
pattern of relapse
quality of life