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

United Kingdom Research and Innovation (UKRI)

Status and phase: Completed; Phase 3; Phase 2

Conditions: Lung Cancer

Treatments: Drug: cisplatin; Drug: vinorelbine tartrate; Radiation: radiation therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT00253591

EU-20535

EU-INCH-20535

EudraCT-2004-004438-15

CDR0000449972

MRC-LU23

Details and patient eligibility

About

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.

Full 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.

Enrollment: 500 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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