- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00864331
Optimization of Treatment of Advanced Nonsmall Cell Lung Cancer Using Radiotherapy and Chemotherapy
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) and stage IV NSCLC (Study B), respectively
Secondary objectives are:
To assess the differences in toxicity of two treatment options in both stage III (A and B) NSCLC (Study A) and Stage IIIB (wet) and stage IV NSCLC (Study B), and To assess the differences in Health Related Quality of Life (HRQoL) of two treatment options in both Study A and Study B
Study Overview
Status
Conditions
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 treatment regimens in patients with locally advanced and metastatic NSCLC (study B)
To compare HRQoL and cost effectiveness of two treatment regimens in patients with locally advanced incurable NSCLC (study A), and in patients with locally advanced and metastatic NSCLC (study B) and to evaluate the effect of HRQoL assessment on QoL dimensions
Study Type
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Locations
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Santiago, Chile
- Instituto de Radiomedicine
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Yinchuan, China
- Affiliated Hospital of Ning Xia Medical College, Department of Radiation Oncology
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Zagreb, Croatia
- University of Zagreb Faculty of Medicine
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Cairo, Egypt
- Misr Oncology Center (MOC)
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Mumbai, India
- Tata Memorial Centre (TMC) Department of Atomic Energy (DAE)
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Kuala Lumpur, Malaysia
- General Hospital Kuala Lumpur, Institute of Radiotherapy and Oncology
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Floriana, Malta
- Sir Paul Boffa Hospital
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Rabat, Morocco
- Ministère de la Santé, Institut National d'Oncologie Sidi Mohamed Ben Abdellah
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Islamabad, Pakistan
- Nuclear Medicine Oncology and Radiotherapy Institute
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Panama City, Panama
- Instituto Oncológico National
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Lima, Peru
- Instituto Nacional de Enfermadades Neoplasicas Depto. De Radioterapia
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Johannesburg, South Africa
- University of Witwatersrand Johannesburg Hospital Dept of Radiation Oncology
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Tunis, Tunisia
- Institut de la Sante Publique, Institut National de Cancer Salah Azaiz
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Study A Inclusion Criteria:
- 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 Criteria:
- 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 Exclusion Criteria:
- Brain metastasis (brain CT and/or MRI not needed, unless symptoms exist - clinically indicated)
- RT field > 200 cm2
- Pregnancy
- A-P separation too large to be adequately treated with 60-Co (?)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Active Comparator: Radiotherapy
For patients in Group A (Stage IIIA or IIIB), EBRT 39 Gy in 13 daily fractions over, with no chemotherapy.
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39 Gy in 13 daily fractions of 3 Gy
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Experimental: Chemotherapy and radiotherapy
For patients in Group A (either stage IIIA or IIIB) receive a course of up to 3 cycles of chemotherapy followed by EBRT of 10 Gy in a single fraction or 16 Gy in 2 fractions 1 week apart.
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Chemotherapy followed by low dose palliative radiotherapy
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Active Comparator: Chemotherapy
For patients in Group B (either stage IIIB (wet) or IV) receive up to 3 cycles of chemotherapy, and no radiotherapy.
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Chemotherapy given alone
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Experimental: Palliative radiotherapy and chemotherapy
For patients in Group B (either stage IIIB (wet) or IV) receive EBRT of 10 Gy in a single fraction or 16 Gy in two fractions 1 week apart, followed by up to 3 cycles of chemotherapy.
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Low dose palliative radiotherapy followed by chemotherapy
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
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Survival
Time Frame: 1 year
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1 year
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
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To assess the differences in toxicity of two treatment options in both stage III (A and B) NSCLC (Study A) and Stage IIIB (wet) and stage IV NSCLC (Study B)
Time Frame: 1 year
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1 year
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To assess the differences in Health Related Quality of Life (HRQoL) of two treatment options in both Study A and Study B
Time Frame: 1 year
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1 year
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Collaborators and Investigators
Investigators
- Principal Investigator: Elena Fidarova, MD, International Atomic Energy Agency
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- E33029
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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