Neoadjuvant or Adjuvant Chemotherapy in Patients With Operable Non-small-cell Lung Cancer (NATCH)

This study has been completed.
Sponsor:
Information provided by:
Spanish Lung Cancer Group
ClinicalTrials.gov Identifier:
NCT00913705
First received: June 2, 2009
Last updated: June 10, 2011
Last verified: June 2011

June 2, 2009
June 10, 2011
September 1999
December 2007   (final data collection date for primary outcome measure)
Evaluate disease-free survival (DFS) and overall survival (OS) [ Time Frame: 5 years ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00913705 on ClinicalTrials.gov Archive Site
Evaluate levels of response and the adverse effects of the chemotherapy [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Neoadjuvant or Adjuvant Chemotherapy in Patients With Operable Non-small-cell Lung Cancer
Randomized Trial of Surgery With or Without Paclitaxel Plus Carboplatin as Neoadjuvant or Adjuvant Chemotherapy in Patients With Operable, Non-small-cell Lung Cancer

Open-label multicenter randomized Phase III trial.

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Non-Small-Cell Lung Cancer
  • 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
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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
624
June 2009
December 2007   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00913705
NATCH - GECP 99/02
Yes
RAFAEL ROSELL, SPANISH LUNG CANCER GROUP
Spanish Lung Cancer Group
Not Provided
Principal Investigator: Enriqueta Felip, MD HOSPITAL VALL D'HEBRON (Barcelona)
Principal Investigator: Rafael Rosell, MD ICO-HOSPITAL UNIV. GERMANS TRIAS I PUJOL (Badalona)
Spanish Lung Cancer Group
June 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP