Status:
COMPLETED
Radiation Therapy With or Without Vinorelbine and Cisplatin in Treating Patients With Stage I, Stage II, or Stage III Non-Small Cell Lung Cancer
Lead Sponsor:
Medical Research Council
Conditions:
Lung Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
PHASE3
Brief 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, eithe...
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 radiother...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
June 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2009
Estimated Enrollment :
500 Patients enrolled
Trial Details
Trial ID
NCT00253591
Start Date
June 1 2005
End Date
December 1 2009
Last Update
December 19 2013
Active Locations (20)
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1
Wansbeck General Hospital
Ashington, England, United Kingdom, NE63 9JJ
2
Bristol Haematology and Oncology Centre
Bristol, England, United Kingdom, BS2 8ED
3
Cheltenham General Hospital
Cheltenham, England, United Kingdom, GL53 7AN
4
Derbyshire Royal Infirmary
Derby, England, United Kingdom, DE1 2QY