Lung Cancer
Conditions
Keywords
stage I non-small cell lung cancer, stage II non-small cell lung cancer, stage IIIA non-small cell lung cancer, stage IIIB non-small cell lung cancer
Brief 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.
Detailed description
OBJECTIVES: Primary * Compare the overall survival of patients with stage I-III non-small cell lung cancer treated with vinorelbine, cisplatin, and continuous hyperfractionated accelerated radiotherapy (CHART) vs CHART alone. Secondary * Compare the response, progression-free survival, and quality of life of patients treated with these regimens. * Compare the toxic effect of these regimens in these patients. * Compare the cost effectiveness of these regimens in these patients. * Compare the local and distant control in patients treated with these regimens. OUTLINE: This is a randomized, multicenter study. Patients are randomized to 1 of 2 treatment arms. * Arm I: Patients undergo continuous hyperfractionated accelerated radiotherapy (CHART) 3 times a day for 12 consecutive days. * Arm II: Patients receive vinorelbine IV over 5-10 minutes on days 1 and 8 and cisplatin IV over 2 hours on day 1. Treatment repeats every 21 days for 3 courses in the absence of disease progression or unacceptable toxicity. Beginning 4-6 weeks later, patients undergo CHART as in arm I. Quality of life is assessed periodically. After completion of study treatment, patients are evaluated periodically for at least 5 years. Peer Reviewed and Funded or Endorsed by Cancer Research UK PROJECTED ACCRUAL: A total of 500 patients will be accrued for this study.
Interventions
DRUGcisplatin
DRUGvinorelbine tartrate
RADIATIONradiation therapy
Sponsors
Medical Research Council
Study design
Allocation
RANDOMIZED
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall survival | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression-free survival | — |
| Toxicity | — |
| Response (complete or partial response) | — |
| Cost effectiveness | — |
Countries
United Kingdom
Outcome results
None listed