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

Phase 2

• Conditions: Lung Cancer

• Registration Number: NCT00398385
• Lead Sponsor: National Cancer Center, Korea

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.

Study Timeline

• Study Start: 2005-05
• Study First Submitted: 2006-11-09
• Study First Submitted QC: 2006-11-09
• Study First Posted: 2006-11-10
• Status Verified: 2008-04
• Primary Completion: 2010-04
• Last Update Submitted: 2013-08-09
• Last Update Posted: 2013-08-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 170

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Time to recurrence

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

National Cancer Center - Korea; 🇰🇷 Goyang, Korea, Republic of