Detection of Plasma DNA in Non Small Cell and Small Cell Lung Cancer Patients

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Gemcitabine and Cisplatin Before or After Surgery in Treating Patients With Stage I or Stage II Non-Small Cell Lung Cancer
This study is currently recruiting participants.
Verified by National Cancer Institute (NCI), April 2008
Sponsored by: National Cancer Center, Korea

Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00398385

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 II




MedlinePlus related topics: Cancer Lung Cancer Surgery
Drug Information available for: Cisplatin Gemcitabine hydrochloride Gemcitabine
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized
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


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)
Detailed Description:
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


Clinical trial summary from the National Cancer Institute's PDQ® database

Study ID Numbers: CDR0000516823, NCC-NCCCTS-05-122
Study First Received: November 9, 2006
Last Updated: February 6, 2009
ClinicalTrials.gov Identifier: NCT00398385 [history]
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 I non-small cell lung cancer
stage II non-small cell lung cancer



Study placed in the following topic categories:
Thoracic Neoplasms
Non-small cell lung cancer
Adenocarcinoma, Bronchiolo-Alveolar
Carcinoma
Adenocarcinoma of lung
Respiratory Tract Diseases
Cisplatin
Lung Neoplasms
Lung Diseases
Adenocarcinoma
Gemcitabine
Carcinoma, Non-Small-Cell Lung
Neoplasms, Glandular and Epithelial



Additional relevant MeSH terms:
Respiratory Tract Neoplasms
Neoplasms by Site
Neoplasms
Neoplasms by Histologic Type
Antimetabolites
Anti-Infective Agents
Antimetabolites, Antineoplastic
Immunologic Factors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Physiological Effects of Drugs
Enzyme Inhibitors
Immunosuppressive Agents
Antiviral Agents
Pharmacologic Actions
Radiation-Sensitizing Agents
Therapeutic Uses



ClinicalTrials.gov processed this record on February 10, 2009


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