Optimization of Treatment of Advanced Nonsmall Cell Lung Cancer Using Radiotherapy and Chemotherapy

Study Overview
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Brief Summary
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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

Detailed Description
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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

Official Title
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Optimization of Treatment of Advanced Nonsmall Cell Lung Cancer Using Radiotherapy and Chemotherapy

Conditions
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Non Small Cell Lung Cancer

Intervention / Treatment
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* Radiation: radiation
* Other: Chemotherapy and radiotherapy
* Drug: Chemotherapy
* Other: Palliative radiotherapy and chemotherapy


Participation Criteria
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Eligibility Criteria
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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 (?)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Radiotherapy<br>For patients in Group A (Stage IIIA or IIIB), EBRT 39 Gy in 13 daily fractions over, with no chemotherapy. | Radiation: radiation<br>* 39 Gy in 13 daily fractions of 3 Gy<br>|
| Experimental: Chemotherapy and radiotherapy<br>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. | Other: Chemotherapy and radiotherapy<br>* Chemotherapy followed by low dose palliative radiotherapy<br>|
| Active Comparator: Chemotherapy<br>For patients in Group B (either stage IIIB (wet) or IV) receive up to 3 cycles of chemotherapy, and no radiotherapy. | Drug: Chemotherapy<br>* Chemotherapy given alone<br>|
| Experimental: Palliative radiotherapy and chemotherapy<br>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. | Other: Palliative radiotherapy and chemotherapy<br>* Low dose palliative radiotherapy followed by chemotherapy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Survival |  | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) |  | 1 year | 
| To assess the differences in Health Related Quality of Life (HRQoL) of two treatment options in both Study A and Study B |  | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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lung cancer, nonsmall cell lung cancer, radiation therapy, chemotherapy, Locally advanced and metastatic nonsmall cell lung cancer