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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
Sponsor:
Information provided by:
Spanish Lung Cancer Group

Tracking Information
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
 (submitted: June 3, 2009)
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
 (submitted: June 3, 2009)
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
Condition  ICMJE Non-Small-Cell Lung Cancer
Intervention  ICMJE
  • Drug: Neoadjuvant chemotherapy (taxol and carboplatin)
    Taxol: 200mg/m2 infusion over 3 hours; Carboplatin: AUC= 6 at the end of the Taxol infusion. Administration of 3 cycles at 21-day intervals. Prior to surgery.
  • Drug: Adjuvant chemotherapy (taxol and carboplatin)
    Taxol: 200mg/m2 infusion over 3 hours; Carboplatin: AUC= 6 at the end of the Taxol infusion. Administration of 3 cycles at 21 days interval. Post-surgery
  • Procedure: Surgery
    Surgery
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:
  • Drug: Neoadjuvant chemotherapy (taxol and carboplatin)
  • Drug: Adjuvant chemotherapy (taxol and carboplatin)
  • Procedure: Surgery
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Estimated Enrollment  ICMJE
 (submitted: June 3, 2009)
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:

  • The patients eligible for the study are those with a diagnosis, histologically or cytologically proven, of NSCLC without metastases at stages IB, IIA, IIB and IIIA (not N2) of the disease. Patients with stage IA and tumor size >2cm will be eligible as well.
  • Patients aged > 18 years.
  • Tumor considered resectable by the attending surgeon.
  • The patient must have an ECOG *2 or Karnofsky >60%.
  • The patients need to have adequate hematological, renal and hepatic function defined as:

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

  • ANC = segmented neutrophils + banded neutrophils

    • The patients should have recovered from any serious surgical sequellae.
    • Informed consent must be obtained from the patient in accordance with the requirements of the IRB/EC.
    • If female, the patient must not be pregnant or breast-feeding. Women of child bearing potential need to have a pregnancy test performed and to take appropriate contraceptive action during the period of the study.
    • Operability criteria: Lung function test will be performed so as to confirm a predictive postoperative value of FEV-1 >-800 ml, i.e. correct homeostasis. A carbon monoxide diffusion test is to be conducted and, when applicable, repeated following the induction treatment while taking into account the sensitivity of post-chemotherapy pulmonary toxicity detection.

Exclusion Criteria:

  • Patients who have previously been treated with chemotherapy and/or radiotherapy.
  • History of significant cardiovascular disease such as non-controlled hypertension, unstable angina or congestive heart failure even if these are controlled by medication. Documented history of acute myocardial infarction in the previous year, ventricular arrhythmias that required medication or 2nd or 3rd atrial-ventricular blocks.
  • Pre-existing sensory or motor neurotoxicity grade >2 based on the WHO criteria.
  • Active infection or other clinical state that could seriously reduce the patient's capacity to tolerate the treatment protocol, including previous allergic reactions to products containing Cremophor (e.g. cyclosporin or vitamin K).
  • Previous or concomitant malignant tumor (with the exception of in situ cervical carcinoma, baso-cellular carcinoma, squamous cell skin carcinoma or urothelial superficial carcinoma) which are considered potentially curable with oncological treatment and have a disease free survival (DFS) greater than 5 years EXCEPTING breast cancer, melanoma and hypernephroma
  • Marked psychoses or senility
Sex/Gender  ICMJE
Sexes Eligible for Study: All
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
Principal Investigator: Enriqueta Felip, MD HOSPITAL VALL D'HEBRON (Barcelona)
Principal Investigator: Rafael Rosell, MD ICO-HOSPITAL UNIV. GERMANS TRIAS I PUJOL (Badalona)
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