Surgery With or Without Preoperative Chemotherapy in Treating Patients With Resectable Non-small Cell Lung Cancer
The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2005 by National Cancer Institute (NCI).
Recruitment status was Active, not recruiting
Recruitment status was Active, not recruiting
Sponsor:
Medical Research Council
Collaborator:
European Organisation for Research and Treatment of Cancer - EORTC
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00003159
First received: November 1, 1999
Last updated: February 26, 2011
Last verified: May 2005
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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 sulfate Drug: vinorelbine tartrate Procedure: conventional surgery Procedure: neoadjuvant therapy |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Primary Purpose: Treatment |
| 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 |
Resource links provided by NLM:
Drug Information available for:
Mitomycin
Vinblastine sulfate
Vinblastine
Ifosfamide
Cisplatin
Paclitaxel
Carboplatin
Vinorelbine
Gemcitabine
Docetaxel
Gemcitabine hydrochloride
Vinorelbine tartrate
U.S. FDA Resources
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 |
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 | |
| 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 Organisation for Research and Treatment of Cancer - EORTC
Investigators
| Investigator: | Adrian Hodson | Medical Research Council |
| Investigator: | Ian E. Smith, MD | Royal Marsden NHS Foundation Trust |
More Information
Additional Information:
Publications:
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.
| ClinicalTrials.gov Identifier: | NCT00003159 History of Changes |
| Other Study ID Numbers: | CDR0000065952, MRC-LU22, EORTC-08012, EU-97016, ISRCTN25582437 |
| Study First Received: | November 1, 1999 |
| Last Updated: | February 26, 2011 |
| 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 |
Additional relevant MeSH terms:
|
Carcinoma, Non-Small-Cell Lung Lung Neoplasms Carcinoma, Bronchogenic Bronchial Neoplasms Respiratory Tract Neoplasms Thoracic Neoplasms Neoplasms by Site Neoplasms Lung Diseases Respiratory Tract Diseases Mitomycins Mitomycin Isophosphamide mustard Gemcitabine Vinorelbine |
Docetaxel Cisplatin Ifosfamide Vinblastine Carboplatin Paclitaxel Antibiotics, Antineoplastic Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Nucleic Acid Synthesis Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Alkylating Agents Radiation-Sensitizing Agents |
ClinicalTrials.gov processed this record on May 16, 2013