Surgery With or Without Preoperative Chemotherapy in Treating Patients With Resectable Non-Small Cell Lung Cancer - Full Text View

Sponsors and Collaborators:	Medical Research Council European Organization for Research and Treatment of Cancer
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00003159

Purpose

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known if surgery is more effective with or without preoperative chemotherapy in treating non-small cell lung cancer.

PURPOSE: This randomized phase III trial is studying surgery and preoperative chemotherapy to see how well they work compared to surgery alone in treating patients with resectable non-small cell lung cancer.

Condition	Intervention	Phase
Lung Cancer	Drug: carboplatin Drug: cisplatin Drug: docetaxel Drug: gemcitabine hydrochloride Drug: ifosfamide Drug: mitomycin C Drug: paclitaxel Drug: vinblastine Drug: vinorelbine ditartrate Procedure: conventional surgery Procedure: neoadjuvant therapy	Phase III

MedlinePlus related topics: Cancer Lung Cancer

Drug Information available for: Ifosfamide Carboplatin Docetaxel Cisplatin Vinorelbine Vinorelbine tartrate Gemcitabine hydrochloride Gemcitabine Paclitaxel Vinblastine Vinblastine sulfate Mitomycin Mitomycins

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Active Control
Official Title:	Randomized Trial of Surgical Resection With or Without Pre-Operative Chemotherapy in Patients With Operable Non-Small Cell Lung Cancer (NSCLC) of Any Stage

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:

Survival [ Designated as safety issue: No ]

Secondary Outcome Measures:

Quality of life as measured by SF-36 questionnaire at baseline, 6 months, 12 months, and then annually thereafter [ Designated as safety issue: No ]
Clinical and post-surgery pathological staging at pre-randomization [ Designated as safety issue: No ]
Resectability rates [ Designated as safety issue: No ]
Extent of surgery [ Designated as safety issue: No ]
Time to and site of relapse [ Designated as safety issue: No ]
Tumor response to chemotherapy [ Designated as safety issue: No ]
Adverse effects of chemotherapy [ Designated as safety issue: Yes ]

Estimated Enrollment:	600
Study Start Date:	August 1997

Detailed Description:

OBJECTIVES:

Primary

Compare the survival of patients with resectable non-small cell lung cancer treated with surgery with or without preoperative chemotherapy.

Secondary

Compare the quality of life of patients treated with these regimens.
Compare pre-randomization clinical and post-surgical pathological staging in patients treated with these regimens.
Compare resectability rates in patients treated with these regimens.
Compare time to and site of relapse in patients treated with these regimens.
Determine response in patients treated with preoperative chemotherapy.
Determine the adverse effects of preoperative chemotherapy in these patients.

OUTLINE: This is a randomized study. Patients are randomized to 1 of 2 treatment arms.

Arm I: Patients undergo surgical resection no more than 4 weeks after randomization.
Arm II: Patients receive one of the following chemotherapy regimens immediately after randomization:
- Regimen 1: Patients receive mitomycin IV, vinblastine IV, and cisplatin IV on day 1.
- Regimen 2: Patients receive mitomycin IV, ifosfamide IV over 3 hours, and cisplatin IV over 1 hour on day 1.
- Regimen 3: Patients receive cisplatin IV over 2 hours on day 1 and vinorelbine IV over 5 -10 minutes on days 1 and 8.
- Regimen 4: Patients receive paclitaxel IV and carboplatin IV on day 1.
- Regimen 5: Patients receive gemcitabine IV on days 1 and 8 and cisplatin IV over 2 hours on day 1.
- Regimen 6: Patients receive docetaxel IV and carboplatin IV on day 1. In all regimens, treatment repeats every 3 weeks for a total of 3 courses. Patients undergo surgical resection at least 4 weeks after the last course of chemotherapy.

Quality of life is assessed at 6 and 12 months and then annually thereafter.

Patients are followed 1 month after surgery, 6 months after randomization, every 3 months for 2 years, and then every 6 months thereafter.

PROJECTED ACCRUAL: A total of 600 patients (300 per treatment arm) will be accrued for this study.

Eligibility

Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

DISEASE CHARACTERISTICS:

Histologically proven non-small cell lung cancer
- Resectable disease
- Previously untreated disease
No evidence of distant metastases

PATIENT CHARACTERISTICS:

Age:

Any age

Performance status:

WHO 0-2

Life expectancy:

Not specified

Hematopoietic:

WBC greater than 3,000/mm^3
Neutrophil count greater than 1,500/mm^3
Platelet count greater than 100,000/mm^3

Hepatic:

Not specified

Renal:

Not specified

Other:

Considered fit for chemotherapy and surgical resection
No other disease or prior malignancy that would preclude study treatment
No active infection

PRIOR CONCURRENT THERAPY:

Biologic therapy:

No concurrent prophylactic colony-stimulating factors (except for secondary prophylaxis)
No concurrent immunotherapy

Chemotherapy:

Not specified

Endocrine therapy:

No concurrent hormonal agents, except corticosteroids

Radiotherapy:

Not specified

Surgery:

Not specified

Other:

No other concurrent anticancer therapy

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00003159

Locations

United Kingdom, England
Medical Research Council Clinical Trials Unit
London, England, United Kingdom, NW1 2DA
Royal Marsden NHS Foundation Trust - Surrey
Sutton, England, United Kingdom, SM2 5PT

Sponsors and Collaborators

Medical Research Council

European Organization for Research and Treatment of Cancer

Investigators

Investigator:	Adrian Hodson	Medical Research Council
Investigator:	Ian E. Smith, MD	Royal Marsden - London

More Information

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

Publications of Results:

Gilligan D, Nicolson M, Smith I, Groen H, Dalesio O, Goldstraw P, Hatton M, Hopwood P, Manegold C, Schramel F, Smit H, van Meerbeeck J, Nankivell M, Parmar M, Pugh C, Stephens R. Preoperative chemotherapy in patients with resectable non-small cell lung cancer: results of the MRC LU22/NVALT 2/EORTC 08012 multicentre randomised trial and update of systematic review. Lancet. 2007 Jun 9;369(9577):1929-37. Review.

Hopwood P, Nankivell M, Pugh C, et al.: Impact of pre-operative chemotherapy on the quality of life (QL) of patients with resectable non-small cell lung cancer (NSCLC): experience from the MRC LU22/NVALT/EORTC 08012 multicentre randomised trial. [Abstract] J Clin Oncol 25 (Suppl 18): A-9020, 498s, 2007.

Nicolson M, Gilligan D, Smith I, et al.: Pre-operative chemotherapy in patients with resectable non-small cell lung cancer (NSCLC): first results of the MRC LU22/NVALT/EORTC 08012 multi-centre randomised trial. [Abstract] J Clin Oncol 25 (Suppl 18): A-7518, 389s, 2007.

Study ID Numbers:	CDR0000065952, MRC-LU22, EORTC-08012, EU-97016, ISRCTN25582437
Study First Received:	November 1, 1999
Last Updated:	July 23, 2008
ClinicalTrials.gov Identifier:	NCT00003159
Health Authority:	United States: Federal Government

Keywords provided by National Cancer Institute (NCI):

stage I non-small cell lung cancer
stage II non-small cell lung cancer
stage IIIA non-small cell lung cancer
stage IIIB non-small cell lung cancer
stage 0 non-small cell lung cancer

Study placed in the following topic categories:

Thoracic Neoplasms
Non-small cell lung cancer
Vinblastine
Carboplatin
Mitomycins
Carcinoma
Docetaxel
Ifosfamide
Vinorelbine
Cisplatin

Respiratory Tract Diseases
Paclitaxel
Lung Neoplasms
Lung Diseases
Mitomycin
Gemcitabine
Carcinoma, Non-Small-Cell Lung
Neoplasms, Glandular and Epithelial
Isophosphamide mustard

Additional relevant MeSH terms:

Antimetabolites
Anti-Infective Agents
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Antineoplastic Agents
Physiological Effects of Drugs
Antibiotics, Antineoplastic
Neoplasms by Site
Therapeutic Uses
Alkylating Agents
Nucleic Acid Synthesis Inhibitors
Respiratory Tract Neoplasms

Neoplasms by Histologic Type
Mitosis Modulators
Enzyme Inhibitors
Antimitotic Agents
Antiviral Agents
Immunosuppressive Agents
Pharmacologic Actions
Neoplasms
Radiation-Sensitizing Agents
Tubulin Modulators
Antineoplastic Agents, Alkylating
Antineoplastic Agents, Phytogenic

ClinicalTrials.gov processed this record on January 14, 2009