Neoadjuvant Chemotherapy in Non Small Cell Lung Cancer (N... | NCT00273507

Studies
Neoadjuvant Chemotherapy in Non Small Cell Lung Cancer (NSCLC) Stages IB, IIA, IIB, and IIIA/T3

NCT00273507

Sponsor

Rigshospitalet, Denmark

Status

Terminated

Last Update Posted

Sep 18, 2009Estimated

Enrollment

270

Phase

Phase 3

Conditions

Non-small Cell Lung Cancer

Interventions

Carboplatin and Paclitaxel

Countries

Denmark

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

Sep 2009

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1998

Primary Completion Date

Not provided

Completion Date

Jan 2006

First Submitted Date

Jan 5, 2006

First Submission Date that Met QC Criteria

Jan 5, 2006

First Posted Date

Jan 9, 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

Sep 17, 2009

Last Update Posted Date

Sep 18, 2009Estimated

Description Module

Brief Summary

Randomised trial of chemotherapy or not before surgery in early resectable stages of NSCLC (IB, IIA, IIB, and IIIA/N2).

Detailed Description

Randomisation between 3 courses of neoadjuvant Carboplatin plus Paclitaxel or no chemotherapy before surgery.

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

270

Name	Type	Description	Arm Group Labels	Other Names
Carboplatin and Paclitaxel	Drug

Measure	Description	Time Frame
Survival

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

NSCLC
Stages IB, IIA, IIB, IIIA/T3
Lung function test allowing surgery
Age 18-75 years

Exclusion Criteria:

Poor lung function
Performance status 3-4
Mediastinal lymph node involvement

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Jens B. Sorensen, MD	Dept. Oncology, Rigshospitalet	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Dept. Oncology, Rigshospitalet		Copenhagen	Copenhagen	2100	Denmark

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
D016190	Carboplatin
D017239	Paclitaxel

Ancestor Terms

ID	Term
D056831	Coordination Complexes
D009930	Organic Chemicals
D043823	Taxoids
D043822	Cyclodecanes

Browse Leaves

Not provided

Browse Branches

Not provided