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

This study has been completed.
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00253591
First received: November 11, 2005
Last updated: December 18, 2013
Last verified: July 2007
  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 tartrate
Radiation: radiation therapy
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


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
Study Completion Date: December 2009
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

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

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00253591     History of Changes
Other Study ID Numbers: CDR0000449972, MRC-LU23, EU-20535, EU-INCH-20535, EudraCT-2004-004438-15
Study First Received: November 11, 2005
Last Updated: December 18, 2013
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

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Vinorelbine
Cisplatin
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents
Antineoplastic Agents, Phytogenic

ClinicalTrials.gov processed this record on October 02, 2014