Neoadjuvant or Adjuvant Chemotherapy in Patients With Operable Non-small-cell Lung Cancer (NATCH)
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ClinicalTrials.gov Identifier: NCT00913705 |
Recruitment Status :
Completed
First Posted : June 4, 2009
Last Update Posted : June 13, 2011
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Sponsor:
Spanish Lung Cancer Group
Information provided by:
Spanish Lung Cancer Group
Tracking Information | |||||||
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First Submitted Date ICMJE | June 2, 2009 | ||||||
First Posted Date ICMJE | June 4, 2009 | ||||||
Last Update Posted Date | June 13, 2011 | ||||||
Study Start Date ICMJE | September 1999 | ||||||
Actual Primary Completion Date | December 2007 (Final data collection date for primary outcome measure) | ||||||
Current Primary Outcome Measures ICMJE |
Evaluate disease-free survival (DFS) and overall survival (OS) [ Time Frame: 5 years ] | ||||||
Original Primary Outcome Measures ICMJE | Same as current | ||||||
Change History | |||||||
Current Secondary Outcome Measures ICMJE |
Evaluate levels of response and the adverse effects of the chemotherapy [ Time Frame: 5 years ] | ||||||
Original Secondary Outcome Measures ICMJE | Same as current | ||||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||||
Descriptive Information | |||||||
Brief Title ICMJE | Neoadjuvant or Adjuvant Chemotherapy in Patients With Operable Non-small-cell Lung Cancer | ||||||
Official Title ICMJE | Randomized Trial of Surgery With or Without Paclitaxel Plus Carboplatin as Neoadjuvant or Adjuvant Chemotherapy in Patients With Operable, Non-small-cell Lung Cancer | ||||||
Brief Summary | Open-label multicenter randomized Phase III trial. | ||||||
Detailed Description | Randomized trial of surgery with or without Paclitaxel (taxol) plus Carboplatin as neoadjuvant or adjuvant chemotherapy in patients with operable, non-small-cell lung cancer. | ||||||
Study Type ICMJE | Interventional | ||||||
Study Phase ICMJE | Phase 3 | ||||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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Condition ICMJE | Non-Small-Cell Lung Cancer | ||||||
Intervention ICMJE |
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Study Arms ICMJE | Experimental: 1
The patients will be randomized to receive taxol (Paclitaxel) and carboplatin as adjuvant or as neoadjuvant regimen or to surgery alone
Interventions:
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Publications * | Not Provided | ||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||
Recruitment Status ICMJE | Completed | ||||||
Estimated Enrollment ICMJE |
624 | ||||||
Original Estimated Enrollment ICMJE | Same as current | ||||||
Actual Study Completion Date ICMJE | June 2009 | ||||||
Actual Primary Completion Date | December 2007 (Final data collection date for primary outcome measure) | ||||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Absolute neutrophil counts (ANC*) *1.5 x 109/L Platelet counts *100 x 109/L Total bilirubin *1.25 x upper limit of normal distribution Serum creatinine <120 umol/L (<1.5 mg/dl) Creatinine clearance >60 ml/min
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||||
Accepts Healthy Volunteers ICMJE | No | ||||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||
Listed Location Countries ICMJE | Not Provided | ||||||
Removed Location Countries | |||||||
Administrative Information | |||||||
NCT Number ICMJE | NCT00913705 | ||||||
Other Study ID Numbers ICMJE | NATCH - GECP 99/02 | ||||||
Has Data Monitoring Committee | Yes | ||||||
U.S. FDA-regulated Product | Not Provided | ||||||
IPD Sharing Statement ICMJE | Not Provided | ||||||
Responsible Party | RAFAEL ROSELL, SPANISH LUNG CANCER GROUP | ||||||
Study Sponsor ICMJE | Spanish Lung Cancer Group | ||||||
Collaborators ICMJE | Not Provided | ||||||
Investigators ICMJE |
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PRS Account | Spanish Lung Cancer Group | ||||||
Verification Date | June 2011 | ||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |