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
  Purpose

Open-label multicenter randomized Phase III trial.


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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Spanish Lung Cancer Group:

Primary Outcome Measures:
  • Evaluate disease-free survival (DFS) and overall survival (OS) [ Time Frame: 5 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Evaluate levels of response and the adverse effects of the chemotherapy [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 624
Study Start Date: September 1999
Study Completion Date: June 2009
Primary Completion Date: December 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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)
  More Information

No publications provided

Responsible Party: RAFAEL ROSELL, SPANISH LUNG CANCER GROUP
ClinicalTrials.gov Identifier: NCT00913705     History of Changes
Other Study ID Numbers: NATCH - GECP 99/02
Study First Received: June 2, 2009
Last Updated: June 10, 2011
Health Authority: Spain: Spanish Agency of Medicines

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

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

ClinicalTrials.gov processed this record on October 02, 2014