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Randomized Trial of Surgery With or Without Paclitaxel Plus Carboplatin as Neoadjuvant or Adjuvant Chemotherapy in Patients With Operable, Non-small-cell Lung Cancer

Phase 3
18 Years
Not Enrolling
Non-Small-Cell Lung Cancer

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Trial Information

Randomized Trial of Surgery With or Without Paclitaxel Plus Carboplatin as Neoadjuvant or Adjuvant Chemotherapy in Patients With Operable, Non-small-cell Lung Cancer

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.

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

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

- 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

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Evaluate disease-free survival (DFS) and overall survival (OS)

Outcome Time Frame:

5 years

Safety Issue:


Principal Investigator

Enriqueta Felip, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:



Spain: Spanish Agency of Medicines

Study ID:

NATCH - GECP 99/02



Start Date:

September 1999

Completion Date:

June 2009

Related Keywords:

  • Non-Small-Cell Lung Cancer
  • LUNG
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms