Status:
COMPLETED
Optimization of Treatment of Advanced Nonsmall Cell Lung Cancer Using Radiotherapy and Chemotherapy
Lead Sponsor:
International Atomic Energy Agency
Conditions:
Non Small Cell Lung Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
Primary objectives of the study are: To assess the differences in survival of the two treatment options in both stage III (A and B) nonsmall cell lung cancer (NSCLC) (Study A) and Stage IIIB (wet) an...
Detailed Description
To compare survival rates (median and 1-year), and toxicity of two treatment regimens in patients with locally advanced incurable NSCLC (study A), to compare survival rates (median and 1-year) of two ...
Eligibility Criteria
Inclusion
- Study A
- Histologically or cytologically confirmed NSCLC
- Stage IIIA/IIIB staged with
- CT chest and upper abdomen
- Liver, renal, hematological reserve appropriate (according to "standard" institutional values)
- Brain CT and/or bone scan only if clinical symptoms request such investigation
- Performance status KPS 60-90
- No second cancer except skin non-melanoma
- No previous treatment
- Patient must be contactable for follow-up
- Patient to be able to start treatment within 2 weeks from randomization (institutional confirmation needed)
- Life expectancy \> 3 months
- Patient must be able and willing to give informed consent, and fill in questionnaires
- Study A
Exclusion
- Stage III B "wet" (existing pleural effusion , but not necessarily cytologically verified)
- RT field \> 200 cm2
- Pregnancy
- Study B Inclusion Criteria:
- KPS 60-90
- Stage IV and Stage III B (existing pleural effusions , but not necessarily cytologically verified)
- Histologically or cytologically confirmed
- CT staged disease (thorax and possible upper abdomen)
- No second cancer except skin non-melanoma
- Liver, renal, haematological reserve appropriate (according to "standard" institutional values)
- No previous treatment
- Patient must be contactable for follow-up
- Patient must be able and willing to give informed consent and fill in questionnaires
- Patient to be able to start treatment within 2 weeks from randomization (institutional confirmation needed)
- Life expectancy \> 3 months
- Study B
Key Trial Info
Start Date :
February 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2012
Estimated Enrollment :
251 Patients enrolled
Trial Details
Trial ID
NCT00864331
Start Date
February 1 2008
End Date
November 1 2012
Last Update
August 7 2013
Active Locations (13)
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1
Instituto de Radiomedicine
Santiago, Chile
2
Affiliated Hospital of Ning Xia Medical College, Department of Radiation Oncology
Yinchuan, China
3
University of Zagreb Faculty of Medicine
Zagreb, Croatia
4
Misr Oncology Center (MOC)
Cairo, Egypt