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

Sponsored by:	Medical Research Council
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00253591

Purpose

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.

Condition	Intervention	Phase
Lung Cancer	Drug: cisplatin Drug: vinorelbine ditartrate Procedure: radiation therapy	Phase II Phase III

MedlinePlus related topics: Cancer Lung Cancer

Drug Information available for: Cisplatin Vinorelbine Vinorelbine tartrate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label
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

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:

Overall survival [ Designated as safety issue: No ]

Secondary Outcome Measures:

Progression-free survival [ Designated as safety issue: No ]
Toxicity [ Designated as safety issue: Yes ]
Response (complete or partial response) [ Designated as safety issue: No ]
Cost effectiveness [ Designated as safety issue: No ]

Estimated Enrollment:	500
Study Start Date:	June 2005
Primary Completion Date:	December 2007 (Final data collection date for primary outcome measure)

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00253591

Locations

United Kingdom, England
Bristol Haematology and Oncology Centre
Bristol, England, United Kingdom, BS2 8ED
Cancer Research Centre at Weston Park Hospital
Sheffield, England, United Kingdom, S1O 2SJ
Cheltenham General Hospital
Cheltenham, England, United Kingdom, GL53 7AN
Churchill Hospital
Oxford, England, United Kingdom, OX3 7LJ
Derbyshire Royal Infirmary
Derby, England, United Kingdom, DE1 2QY
Nottingham City Hospital NHS Trust
Nottingham, England, United Kingdom, NG5 1PB
Kings Mill Hospital
Nottinghamshire, England, United Kingdom, NG17 4JL
Mount Vernon Cancer Centre at Mount Vernon Hospital
Northwood, England, United Kingdom, HA6 2RN
Northern Centre for Cancer Treatment at Newcastle General Hospital
Newcastle-Upon-Tyne, England, United Kingdom, NE4 6BE
Great Western Hospital
Swindon, England, United Kingdom, SN3 6BB
Queen Elizabeth Hospital
Gateshead, England, United Kingdom, NE9 6SX
University Hospital of North Durham
Durham, England, United Kingdom, DH1 5TW
Wansbeck General Hospital
Ashington, England, United Kingdom, NE63 9JJ
Worcester Royal Hospital
Worcester, England, United Kingdom, WR5 1DD
Yeovil District Hospital
Yeovil, England, United Kingdom, BA21 4AT
United Kingdom, Scotland
Beatson West of Scotland Cancer Centre
Glasgow, Scotland, United Kingdom, G12 0YN
Crosshouse Hospital
Kilmarnock, Scotland, United Kingdom, KA2 OBE
United Kingdom, Wales
Llandough Hospital
Llandough, Wales, United Kingdom, CF64 2XX
Royal Gwent Hospital
Newport Gwent, Wales, United Kingdom, NP9 2UB
Velindre Cancer Center at Velindre Hospital
Cardiff, Wales, United Kingdom, CF14 2TL

Sponsors and Collaborators

Medical Research Council

Investigators

Study Chair:

Matthew Hatton, MD

Cancer Research Centre at Weston Park Hospital

More Information

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

Study ID Numbers:	CDR0000449972, MRC-LU23, EU-20535, EU-INCH-20535, EudraCT-2004-004438-15
Study First Received:	November 11, 2005
Last Updated:	July 23, 2008
ClinicalTrials.gov Identifier:	NCT00253591
Health Authority:	United States: Federal Government

Keywords provided by National Cancer Institute (NCI):

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 placed in the following topic categories:

Thoracic Neoplasms
Non-small cell lung cancer
Vinorelbine
Cisplatin
Respiratory Tract Diseases
Lung Neoplasms

Lung Diseases
Vinblastine
Carcinoma, Non-Small-Cell Lung
Neoplasms, Glandular and Epithelial
Carcinoma

Additional relevant MeSH terms:

Respiratory Tract Neoplasms
Neoplasms by Histologic Type
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Physiological Effects of Drugs
Mitosis Modulators
Antimitotic Agents

Pharmacologic Actions
Neoplasms
Neoplasms by Site
Radiation-Sensitizing Agents
Therapeutic Uses
Tubulin Modulators
Antineoplastic Agents, Phytogenic

ClinicalTrials.gov processed this record on January 14, 2009