Conditions: Lung Cancer
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 75
Healthy volunteers: no

Brief 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

Arms:
arm 1: Patients with potentially resectable clinical stage IB, II, and selected III NSCLC received gemcitabine 1000 mg/m2 days 1, 8 and docetaxel 30 mg/m2 days 1, 8 every 21 days for 3 cycles. Patients were restaged after treatment and resected 3-6 weeks later. If patients were inoperable, had incomplete resections or N2 disease, docetaxel 20 mg/m2 and carboplatin AUC = 1.5 weekly x 7 and radiation to 63 Gy was administered

Interventions: intervention 1: Docetaxel intervention 2: Gemcitabine intervention 3: Carboplatin intervention 4: Radiation
Intervention descriptions: intervention 1: 30mg/m2 administered on days 1 and 8, 21-cycle days, 3 cycles intervention 2: 1000 mg/m2 administered by 30-minute IV infusion on day 1 and 8, 21-cycle days, 3 cycles intervention 3: AUC = 1.5 weekly x 7 intervention 4: To 63 Gy

Protocol document: