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
18 Years
N/A
Both
Lung Cancer
Trial Information
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
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.
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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Overall survival
Safety Issue:
No
Principal Investigator
Matthew Hatton, MD
Investigator Role:
Study Chair
Investigator Affiliation:
Cancer Research Centre at Weston Park Hospital
Authority:
United States: Federal Government
Study ID:
CDR0000449972
NCT ID:
NCT00253591
Start Date:
June 2005
Completion Date:
Related Keywords:
- Lung Cancer
- 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
- Carcinoma, Non-Small-Cell Lung
- Lung Neoplasms
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