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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

Brief Summary:
Open-label multicenter randomized Phase III trial.

Condition or disease Intervention/treatment Phase
Non-Small-Cell Lung Cancer Drug: Neoadjuvant chemotherapy (taxol and carboplatin) Drug: Adjuvant chemotherapy (taxol and carboplatin) Procedure: Surgery Phase 3

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 : Interventional  (Clinical Trial)
Estimated Enrollment : 624 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Randomized Trial of Surgery With or Without Paclitaxel Plus Carboplatin as Neoadjuvant or Adjuvant Chemotherapy in Patients With Operable, Non-small-cell Lung Cancer
Study Start Date : September 1999
Actual Primary Completion Date : December 2007
Actual Study Completion Date : June 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer

Arm Intervention/treatment
Experimental: 1
The patients will be randomized to receive taxol (Paclitaxel) and carboplatin as adjuvant or as neoadjuvant regimen or to surgery alone
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




Primary Outcome Measures :
  1. Evaluate disease-free survival (DFS) and overall survival (OS) [ Time Frame: 5 years ]

Secondary Outcome Measures :
  1. Evaluate levels of response and the adverse effects of the chemotherapy [ Time Frame: 5 years ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00913705


Sponsors and Collaborators
Spanish Lung Cancer Group
Investigators
Principal Investigator: Enriqueta Felip, MD HOSPITAL VALL D'HEBRON (Barcelona)
Principal Investigator: Rafael Rosell, MD ICO-HOSPITAL UNIV. GERMANS TRIAS I PUJOL (Badalona)

Responsible Party: RAFAEL ROSELL, SPANISH LUNG CANCER GROUP
ClinicalTrials.gov Identifier: NCT00913705     History of Changes
Other Study ID Numbers: NATCH - GECP 99/02
First Posted: June 4, 2009    Key Record Dates
Last Update Posted: June 13, 2011
Last Verified: June 2011

Keywords provided by Spanish Lung Cancer Group:
NATCH
LUNG
OPERABLE NSCLC
SURGERY PLUS ADJUVANT THERAPY
SURGERY PLUS NEOADJUVANT THERAPY

Additional relevant MeSH terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Carboplatin
Paclitaxel
Albumin-Bound Paclitaxel
Antineoplastic Agents
Antineoplastic Agents, Phytogenic
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action