NCT00193427

Preoperative Therapy in Patients With Stages IB, II, IIIA, and Selected IIIB Patients With Non-Small Cell Lung Cancer

Phase II Trial of Preoperative (Neo-adjuvant) Therapy in Patients With Stages IB, II, IIIA, and Selected IIIB Patients With Non-Small Cell Lung Cancer

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 75 (actual)
• Sponsor: SCRI Development Innovations, LLC · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This trial is designed to study the role of docetaxel/gemcitabine, an active and relatively non-toxic combination in advanced NSCLC. This study will help to better define optimal preoperative regimens for patients with resectable NSCLC. Since both of these drugs are potent radio-sensitizers, the concurrent use with radiation therapy at these weekly doses may produce not only radio-sensitization, but also considerable antitumor efficacy.

Detailed description

Upon determination of eligibility, patients will receive: Pre-operative * Docetaxel * Gemcitabine Post-operative * Docetaxel * Carboplatin * Radiation Therapy Patients with stage IB and II NSCLC who achieved clear margins will not receive any further therapy. Patients with incomplete resection, resection margins of a T3 tumor that are positive or close, stage IIIA AND IIIB NSCLC or disease judged unresectable after preoperative chemotherapy will receive postoperative treatment

Conditions

• Lung Cancer

Interventions

Type	Name	Description
DRUG	Docetaxel	30mg/m2 administered on days 1 and 8, 21-cycle days, 3 cycles
DRUG	Gemcitabine	1000 mg/m2 administered by 30-minute IV infusion on day 1 and 8, 21-cycle days, 3 cycles
DRUG	Carboplatin	AUC = 1.5 weekly x 7
RADIATION	Radiation	To 63 Gy

Timeline

• Start date: 2004-04-01
• Primary completion: 2008-11-01
• Completion: 2008-12-01
• First posted: 2005-09-19
• Last updated: 2022-03-03
• Results posted: 2012-11-13

Locations

1 site across 1 country: United States