Gemcitabine and Cisplatin Before or After Surgery in Treating Patients With Stage I or Stage II Non-Small Cell Lung Cancer
The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2008 by National Cancer Institute (NCI).
Recruitment status was Recruiting
Recruitment status was Recruiting
Sponsor:
National Cancer Center, Korea
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00398385
First received: November 9, 2006
Last updated: August 3, 2010
Last verified: April 2008
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Purpose
RATIONALE: Drugs used in chemotherapy, such as gemcitabine and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving chemotherapy before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. Giving chemotherapy after surgery may kill any tumor cells that remain after surgery. It is not yet known whether giving chemotherapy before surgery is more effective than giving it after surgery in treating non-small cell lung cancer.
PURPOSE: This randomized phase II trial is studying gemcitabine and cisplatin to compare how well they work when given before or after surgery in treating patients with stage I or stage II non-small cell lung cancer.
| Condition | Intervention | Phase |
|---|---|---|
|
Lung Cancer |
Drug: cisplatin Drug: gemcitabine hydrochloride Procedure: adjuvant therapy Procedure: conventional surgery Procedure: neoadjuvant therapy |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Primary Purpose: Treatment |
| Official Title: | A Randomized Phase II Study of Preoperative Versus Postoperative Gemcitabine and Cisplatin for Patients With Stage IB-II Non-Small Cell Lung Cancer |
Resource links provided by NLM:
Further study details as provided by National Cancer Institute (NCI):
Primary Outcome Measures:
- Time to recurrence [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Overall survival [ Designated as safety issue: No ]
- Toxicity [ Designated as safety issue: Yes ]
- Safety, in terms of frequency, severity, and relationship of adverse events, as assessed by NCI CTCAE v3.0 [ Designated as safety issue: Yes ]
- Complete resection rate [ Designated as safety issue: No ]
- Quality of life as assessed by EORTC QLQ-C30 and EORTC QLQ-LC13 at baseline and periodically for 5 years [ Designated as safety issue: No ]
- Patient population most at risk for disease recurrence [ Designated as safety issue: No ]
| Estimated Enrollment: | 170 |
| Study Start Date: | May 2005 |
| Estimated Primary Completion Date: | April 2010 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
- Compare the time to recurrence in patients with stage IB or II non-small cell lung cancer treated with neoadjuvant versus adjuvant gemcitabine hydrochloride and cisplatin.
Secondary
- Compare overall survival of patients treated with these regimens.
- Compare the toxicity of these regimens in these patients.
- Compare quality of life of these patients.
- Compare the complete resection rate with and without neoadjuvant gemcitabine hydrochloride and cisplatin.
OUTLINE: This is a randomized study. Patients are stratified by disease stage (IB vs II) and histology (squamous cell carcinoma vs nonsquamous cell carcinoma). Patients are randomized to 1 of 2 treatment arms.
- Arm I (neoadjuvant chemotherapy): Patients receive gemcitabine hydrochloride IV over 30 minutes and cisplatin IV over 30 minutes on days 1 and 15. Treatment repeats every 4 weeks for up to 4 courses in the absence of disease recurrence or unacceptable toxicity. Within 8 weeks after initiating course 4 of chemotherapy, patients undergo complete surgical resection.
- Arm II (adjuvant chemotherapy): Patients undergo complete surgical resection. Beginning within 8 weeks after complete surgical resection, patients receive gemcitabine hydrochloride IV and cisplatin IV as in arm I.
Quality of life is assessed at baseline and periodically for up to 5 years.
After completion of study therapy, patients are followed periodically for at least 5 years or until disease recurrence.
PROJECTED ACCRUAL: A total of 170 patients will be accrued for this study.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
DISEASE CHARACTERISTICS:
Histologically or cytologically confirmed non-small cell lung cancer (NSCLC)
- Squamous cell or nonsquamous cell histology
- Stage IB or II disease
- Tumor amenable to curative surgical resection
PATIENT CHARACTERISTICS:
- ECOG performance status 0-1
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception during and for 6 months after completion of study therapy
- Medical fitness must be adequate for radical NSCLC surgery
- WBC ≥ 4,000/mm³
- Absolute neutrophil count ≥ 1,500/mm³
- Platelet count ≥ 100,000/mm³
- Hemoglobin ≥ 10 g/dL
- Bilirubin normal
- ALT and AST ≤ 2.5 times upper limit of normal
- Creatinine ≤ 1.5 mg/dL
- No second primary malignancy
- No active uncontrolled infection
- No concurrent serious disorder that would compromise patient safety or tolerance of study therapy
- No significant neurological or mental disorder
- No myocardial infarction within the past 6 months
No symptomatic heart disease, including any of the following:
- Unstable angina
- Congestive heart failure
- Uncontrolled arrhythmia
PRIOR CONCURRENT THERAPY:
- No prior chemotherapy or anticancer therapy
- No prior surgery for NSCLC
- No prior or concurrent radiotherapy or immunotherapy (e.g., biologic response modifier)
- No major surgery (other than biopsy) within the past 2 weeks
- No other concurrent anticancer therapy
- No other concurrent investigational agents
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00398385
Locations
| Korea, Republic of | |
| National Cancer Center - Korea | Recruiting |
| Goyang, Korea, Republic of, 410-769 | |
| Contact: Heungtae T. Kim, MD, PhD 82-31-920-1622 htkim@ncc.re.kr | |
Sponsors and Collaborators
National Cancer Center, Korea
Investigators
| Study Chair: | Heungtae T. Kim, MD, PhD | National Cancer Center, Korea |
More Information
Additional Information:
No publications provided
| ClinicalTrials.gov Identifier: | NCT00398385 History of Changes |
| Other Study ID Numbers: | CDR0000516823, NCC-NCCCTS-05-122 |
| Study First Received: | November 9, 2006 |
| Last Updated: | August 3, 2010 |
| Health Authority: | Unspecified |
Keywords provided by National Cancer Institute (NCI):
|
squamous cell lung cancer adenocarcinoma of the lung adenosquamous cell lung cancer bronchoalveolar cell lung cancer |
large cell lung cancer stage IB non-small cell lung cancer stage IIA non-small cell lung cancer stage IIB 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 Gemcitabine Cisplatin Antineoplastic Agents |
Therapeutic Uses Pharmacologic Actions Radiation-Sensitizing Agents Physiological Effects of Drugs Antimetabolites, Antineoplastic Antimetabolites Molecular Mechanisms of Pharmacological Action Antiviral Agents Anti-Infective Agents Enzyme Inhibitors Immunosuppressive Agents Immunologic Factors |
ClinicalTrials.gov processed this record on June 17, 2013