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

NCT ID: NCT00253591

Last Updated: 2013-12-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 500 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-06-30
• Study Completion Date: 2009-12-31

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.

Conditions

Lung Cancer

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

Study Design

• Allocation Method: RANDOMIZED
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

cisplatin

Intervention Type: DRUG

vinorelbine tartrate

Intervention Type: DRUG

radiation therapy

Intervention Type: RADIATION

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medical Research Council

OTHER_GOV

Sponsor Role: lead

Principal Investigators

Matthew Hatton, MD

Role: STUDY_CHAIR

Cancer Research Centre at Weston Park Hospital

Locations

Wansbeck General Hospital

Ashington, England, United Kingdom

Bristol Haematology and Oncology Centre

Bristol, England, United Kingdom

Cheltenham General Hospital

Cheltenham, England, United Kingdom

Derbyshire Royal Infirmary

Derby, England, United Kingdom

University Hospital of North Durham

Durham, England, United Kingdom

Queen Elizabeth Hospital

Gateshead, England, United Kingdom

Northern Centre for Cancer Treatment at Newcastle General Hospital

Newcastle upon Tyne, England, United Kingdom

Mount Vernon Cancer Centre at Mount Vernon Hospital

Northwood, England, United Kingdom

Nottingham City Hospital NHS Trust

Nottingham, England, United Kingdom

Kings Mill Hospital

Nottinghamshire, England, United Kingdom

Churchill Hospital

Oxford, England, United Kingdom

Cancer Research Centre at Weston Park Hospital

Sheffield, England, United Kingdom

Great Western Hospital

Swindon, England, United Kingdom

Worcester Royal Hospital

Worcester, England, United Kingdom

Yeovil District Hospital

Yeovil, England, United Kingdom

Beatson West of Scotland Cancer Centre

Glasgow, Scotland, United Kingdom

Crosshouse Hospital

Kilmarnock, Scotland, United Kingdom

Velindre Cancer Center at Velindre Hospital

Cardiff, Wales, United Kingdom

Llandough Hospital

Llandough, Wales, United Kingdom

Royal Gwent Hospital

Newport Gwent, Wales, United Kingdom

Countries

United Kingdom

Other Identifiers

MRC-LU23

Identifier Type: -

Identifier Source: secondary_id

EU-20535

Identifier Type: -

Identifier Source: secondary_id

EU-INCH-20535

Identifier Type: -

Identifier Source: secondary_id

EudraCT-2004-004438-15

Identifier Type: -

Identifier Source: secondary_id

CDR0000449972

Identifier Type: -

Identifier Source: org_study_id