Radiation Therapy With or Without Vinorelbine and Cisplatin in Treating Patients With Stage I, Stage II, or Stage III Non-Small Cell Lung Cancer

• Status: Completed
• Trial end date: 2009-12-01
• Target enrollment: 0
• Participant gender: All

Summary

RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs used in chemotherapy, such as vinorelbine and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. It is not yet known whether giving radiation therapy together with vinorelbine and cisplatin is more effective than radiation therapy alone in treating non-small cell lung cancer.

PURPOSE: This randomized phase II/III trial is studying how well giving radiation therapy together with vinorelbine and cisplatin works and compares it to radiation therapy alone in treating patients with stage I, stage II, or stage III non-small cell lung cancer.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Medical Research Council
• Treatments: Cisplatin; Vinorelbine

Criteria

DISEASE CHARACTERISTICS:

• Histologically or cytologically confirmed stage I-III non-small cell lung cancer

• Inoperable or patient refuses surgery

• Disease can be encompassed within the radical radiotherapy treatment volume

PATIENT CHARACTERISTICS:

Performance status

• ECOG 0-1

Life expectancy

• More than 3 months

Hematopoietic

• Absolute neutrophil count > 1,500/mm^3

• Platelet count > 100,000/mm^3

Hepatic

• Bilirubin < 1.5 times upper limit of normal

Renal

• Glomerular filtration rate > 60 mL/min

Cardiovascular

• No uncontrolled arterial hypertension

• No ischemic heart disease

Pulmonary

• FEV_1 > 50% of predicted OR

• DLCO > 50% of predicted

Other

• Not pregnant or nursing

• Negative pregnancy test

• Fertile patients must use effective contraception

• No prior or current malignancy that would preclude study treatment

• Medically stable

• No unstable diabetes

• No infection

• No hypercalcemia

PRIOR CONCURRENT THERAPY:

Chemotherapy

• No prior chemotherapy

Radiotherapy

• See Disease Characteristics

• No prior radiotherapy