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

• ClinicalTrials.gov Identifier: NCT00913705
• Recruitment Status: Completed
• First Posted: June 4, 2009
• Last Update Posted: June 13, 2011
• Sponsor: Spanish Lung Cancer Group
• Information provided by: Spanish Lung Cancer Group

Study Description

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 Design

• 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

Arms and Interventions

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

Outcome Measures

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 ]

Eligibility Criteria

• 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

Contacts and Locations

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

• Responsible Party: RAFAEL ROSELL, SPANISH LUNG CANCER GROUP
• ClinicalTrials.gov Identifier: NCT00913705
• Other Study ID Numbers: NATCH - GECP 99/02
• First Posted: June 4, 2009
• 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