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

NCT00913705 | Completed Phase 3 DMC

• 1 other identifier: NATCH - GECP 99/02
• Study Type: interventional
• Target: 624
• Locations: 0 countries
• Sites: N/A

Brief Summary

Open-label multicenter randomized Phase III trial.

Conditions

Non-Small-Cell Lung Cancer

Keywords

NATCH; LUNG; OPERABLE NSCLC; SURGERY PLUS ADJUVANT THERAPY; SURGERY PLUS NEOADJUVANT THERAPY

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Evaluate levels of response and the adverse effects of the chemotherapy

  5 years

Study Arms (1)

1

EXPERIMENTAL

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); Drug: Adjuvant chemotherapy (taxol and carboplatin); Procedure: Surgery

Interventions

Neoadjuvant chemotherapy (taxol and carboplatin) DRUG

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.

1

Adjuvant chemotherapy (taxol and carboplatin) DRUG

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

1

Surgery PROCEDURE

Surgery

1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Spanish Lung Cancer Group: lead

Related Publications (1)

• Felip E, Rosell R, Maestre JA, Rodriguez-Paniagua JM, Moran T, Astudillo J, Alonso G, Borro JM, Gonzalez-Larriba JL, Torres A, Camps C, Guijarro R, Isla D, Aguilo R, Alberola V, Padilla J, Sanchez-Palencia A, Sanchez JJ, Hermosilla E, Massuti B; Spanish Lung Cancer Group. Preoperative chemotherapy plus surgery versus surgery plus adjuvant chemotherapy versus surgery alone in early-stage non-small-cell lung cancer. J Clin Oncol. 2010 Jul 1;28(19):3138-45. doi: 10.1200/JCO.2009.27.6204. Epub 2010 Jun 1.

  PMID: 20516435 RESULT

Related Links

• Web page of the sponsor where users can find more information about Fundación GECP studies

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

Neoadjuvant Therapy; Paclitaxel; Carboplatin; Chemotherapy, Adjuvant; Surgical Procedures, Operative

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Combined Modality Therapy; Therapeutics; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Coordination Complexes; Drug Therapy

Study Officials

• Enriqueta Felip, MD

  HOSPITAL VALL D'HEBRON (Barcelona)

  PRINCIPAL INVESTIGATOR

• Rafael Rosell, MD

  ICO-HOSPITAL UNIV. GERMANS TRIAS I PUJOL (Badalona)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 2, 2009
• First Posted: June 4, 2009
• Study Start: September 1, 1999
• Primary Completion: December 1, 2007
• Study Completion: June 1, 2009
• Last Updated: June 13, 2022

Record last verified: 2022-06