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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

Primary Purpose

Lung Cancer

Status

Unknown status

Phase

Phase 2

Locations

Korea, Republic of

Study Type

Interventional

Intervention

cisplatin

gemcitabine hydrochloride

adjuvant therapy

conventional surgery

neoadjuvant therapy

About this trial

This is an interventional treatment trial for Lung Cancer focused on measuring 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

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

National Cancer Center - KoreaRecruiting

Outcomes

Primary Outcome Measures

Time to recurrence

Secondary Outcome Measures

Overall survival

Toxicity

Safety, in terms of frequency, severity, and relationship of adverse events, as assessed by NCI CTCAE v3.0

Complete resection rate

Quality of life as assessed by EORTC QLQ-C30 and EORTC QLQ-LC13 at baseline and periodically for 5 years

Patient population most at risk for disease recurrence

Full Information

NCT ID

NCT00398385

First Posted

November 9, 2006

Last Updated

August 9, 2013

Sponsor

National Cancer Center, Korea

1. Study Identification

Unique Protocol Identification Number

NCT00398385

Brief Title

Gemcitabine and Cisplatin Before or After Surgery in Treating Patients With Stage I or Stage II Non-Small Cell Lung Cancer

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2008

Overall Recruitment Status

Unknown status

Study Start Date

May 2005 (undefined)

Primary Completion Date

April 2010 (Anticipated)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor

National Cancer Center, Korea

4. Oversight

5. Study Description

Brief Summary

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Lung Cancer

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Allocation

Randomized

Enrollment

170 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

cisplatin

Intervention Type

Drug

Intervention Name(s)

gemcitabine hydrochloride

Intervention Type

Procedure

Intervention Name(s)

adjuvant therapy

Intervention Type

Procedure

Intervention Name(s)

conventional surgery

Intervention Type

Procedure

Intervention Name(s)

neoadjuvant therapy

Primary Outcome Measure Information:

Title

Time to recurrence

Secondary Outcome Measure Information:

Title

Overall survival

Title

Toxicity

Title

Safety, in terms of frequency, severity, and relationship of adverse events, as assessed by NCI CTCAE v3.0

Title

Complete resection rate

Title

Quality of life as assessed by EORTC QLQ-C30 and EORTC QLQ-LC13 at baseline and periodically for 5 years

Title

Patient population most at risk for disease recurrence

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Heungtae T. Kim, MD, PhD

Organizational Affiliation

National Cancer Center, Korea

Official's Role

Study Chair

Facility Information:

Facility Name

National Cancer Center - Korea

City

Goyang

ZIP/Postal Code

410-769

Country

Korea, Republic of

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Heungtae T. Kim, MD, PhD

Phone

82-31-920-1622

htkim@ncc.re.kr

12. IPD Sharing Statement

Learn more about this trial

Gemcitabine and Cisplatin Before or After Surgery in Treating Patients With Stage I or Stage II Non-Small Cell Lung Cancer

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