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

Study Overview
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Brief Summary
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Open-label multicenter randomized Phase III trial.

Detailed Description
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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.

Official Title
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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

Conditions
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Non-Small-Cell Lung Cancer

Intervention / Treatment
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* Drug: Neoadjuvant chemotherapy (taxol and carboplatin)
* Drug: Adjuvant chemotherapy (taxol and carboplatin)
* Procedure: Surgery


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>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)<br>* 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.<br>Drug: Adjuvant chemotherapy (taxol and carboplatin)<br>* 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<br>Procedure: Surgery<br>* Surgery<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluate disease-free survival (DFS) and overall survival (OS) | DFS: defined as the length of time from the date of diagnosis to the date of the first documented progression of disease OS: defined as the length of time from either the date of diagnosis or the start of the treatment that patients diagnosed with the disease are still alive. | 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluate levels of response and the adverse effects of the chemotherapy | Occurrence and severity of adverse events | 5 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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NATCH, LUNG, OPERABLE NSCLC, SURGERY PLUS ADJUVANT THERAPY, SURGERY PLUS NEOADJUVANT THERAPY