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

Lung Cancer Clinical Trial

Official title:

Randomised Phase II/III Trial of Induction Chemotherapy Followed by Continuous Hyperfractionated Accelerated Radiotherapy (CHART) Versus CHART Alone in Patients With Inoperable Non-Small Cell Lung Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00253591
• Other study ID #: CDR0000449972
• Secondary ID: MRC-LU23EU-20535
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: November 11, 2005
• Last updated: December 18, 2013
• Start date: June 2005
• Est. completion date: December 2009

Study information

• Verified date: July 2007
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 500
• Est. completion date: December 2009
• Est. primary completion date: December 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Cancer
• Lung Neoplasms

Intervention

Drug:
• cisplatin

• vinorelbine tartrate

Radiation:
• radiation therapy

Locations

Country	Name	City	State
United Kingdom	Wansbeck General Hospital	Ashington	England
United Kingdom	Bristol Haematology and Oncology Centre	Bristol	England
United Kingdom	Velindre Cancer Center at Velindre Hospital	Cardiff	Wales
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	Beatson West of Scotland Cancer Centre	Glasgow	Scotland
United Kingdom	Crosshouse Hospital	Kilmarnock	Scotland
United Kingdom	Llandough Hospital	Llandough	Wales
United Kingdom	Northern Centre for Cancer Treatment at Newcastle General Hospital	Newcastle-Upon-Tyne	England
United Kingdom	Royal Gwent Hospital	Newport Gwent	Wales
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

Sponsors (1)

Lead Sponsor	Collaborator
Medical Research Council

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall survival			No
Secondary	Progression-free survival			No
Secondary	Toxicity			Yes
Secondary	Response (complete or partial response)			No
Secondary	Cost effectiveness			No