Radiation Therapy With or Without Vinorelbine and Cisplatin in Treating Patients With Stage I, Stage II, or Stage III Non-Small Cell Lung Cancer
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.
|Lung Cancer||Drug: cisplatin Drug: vinorelbine tartrate Radiation: radiation therapy||Phase 2 Phase 3|
|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|
- Overall survival
- Progression-free survival
- Response (complete or partial response)
- Cost effectiveness
|Study Start Date:||June 2005|
|Study Completion Date:||December 2009|
|Primary Completion Date:||December 2007 (Final data collection date for primary outcome measure)|
- 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.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00253591
|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|
|Kings Mill Hospital|
|Nottinghamshire, England, United Kingdom, NG17 4JL|
|Nottingham City Hospital NHS Trust|
|Nottingham, England, United Kingdom, NG5 1PB|
|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|
|Kilmarnock, Scotland, United Kingdom, KA2 OBE|
|Velindre Cancer Center at Velindre Hospital|
|Cardiff, Wales, United Kingdom, CF14 2TL|
|Llandough, Wales, United Kingdom, CF64 2XX|
|Royal Gwent Hospital|
|Newport Gwent, Wales, United Kingdom, NP9 2UB|
|Study Chair:||Matthew Hatton, MD||Cancer Research Centre at Weston Park Hospital|