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

Tracking Information

• First Submitted Date: June 2, 2009
• First Posted Date: June 4, 2009
• Last Update Posted Date: June 13, 2011
• Study Start Date: September 1999
• Actual Primary Completion Date: December 2007 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: June 3, 2009): Evaluate disease-free survival (DFS) and overall survival (OS) [ Time Frame: 5 years ]
• Original Primary Outcome Measures: Same as current
• Current Secondary Outcome Measures (submitted: June 3, 2009): Evaluate levels of response and the adverse effects of the chemotherapy [ Time Frame: 5 years ]
• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Neoadjuvant or Adjuvant Chemotherapy in Patients With Operable Non-small-cell Lung Cancer
• 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
• 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: Interventional
• Study Phase: Phase 3
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Non-Small-Cell Lung Cancer

Intervention

• 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

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

Recruitment Information

• Recruitment Status: Completed
• Estimated Enrollment (submitted: June 3, 2009): 624
• Original Estimated Enrollment: Same as current
• Actual Study Completion Date: June 2009
• Actual Primary Completion Date: December 2007 (Final data collection date for primary outcome measure)

Eligibility 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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Not Provided

Administrative Information

• NCT Number: NCT00913705
• Other Study ID Numbers: NATCH - GECP 99/02
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: RAFAEL ROSELL, SPANISH LUNG CANCER GROUP
• Study Sponsor: Spanish Lung Cancer Group
• Collaborators: Not Provided

Investigators

• 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