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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
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Radiotherapy | Active Comparator | For patients in Group A (Stage IIIA or IIIB), EBRT 39 Gy in 13 daily fractions over, with no chemotherapy. |
|
| Chemotherapy and radiotherapy | Experimental | 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. |
|
| Chemotherapy | Active Comparator | For patients in Group B (either stage IIIB (wet) or IV) receive up to 3 cycles of chemotherapy, and no radiotherapy. |
|
| Palliative radiotherapy and chemotherapy | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| radiation | Radiation | 39 Gy in 13 daily fractions of 3 Gy |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Survival | 1 year |
| 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 |
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Study A Inclusion Criteria:
Study A Exclusion Criteria:
Study B Inclusion Criteria:
Study B Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Elena Fidarova, MD | International Atomic Energy Agency | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Instituto de Radiomedicine | Santiago | Chile | ||||
| Affiliated Hospital of Ning Xia Medical College, Department of Radiation Oncology |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26163093 | Derived | Jeremic B, Fidarova E, Sharma V, Faheem M, Ameira AA, Nasr Ben Ammar C, Frobe A, Lau F, Brincat S, Jones G. The International Atomic Energy Agency (IAEA) randomized trial of palliative treatment of incurable locally advanced non small cell lung cancer (NSCLC) using radiotherapy (RT) and chemotherapy (CHT) in limited resource setting. Radiother Oncol. 2015 Jul;116(1):21-6. doi: 10.1016/j.radonc.2015.06.017. Epub 2015 Jul 7. |
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| Chemotherapy and radiotherapy |
| Other |
Chemotherapy followed by low dose palliative radiotherapy |
|
| Chemotherapy | Drug | Chemotherapy given alone |
|
| Palliative radiotherapy and chemotherapy | Other | Low dose palliative radiotherapy followed by chemotherapy |
|
| 1 year |
| Yinchuan |
| China |
| University of Zagreb Faculty of Medicine | Zagreb | Croatia |
| Misr Oncology Center (MOC) | Cairo | Egypt |
| Tata Memorial Centre (TMC) Department of Atomic Energy (DAE) | Mumbai | India |
| General Hospital Kuala Lumpur, Institute of Radiotherapy and Oncology | Kuala Lumpur | Malaysia |
| Sir Paul Boffa Hospital | Floriana | Malta |
| Ministère de la Santé, Institut National d'Oncologie Sidi Mohamed Ben Abdellah | Rabat | Morocco |
| Nuclear Medicine Oncology and Radiotherapy Institute | Islamabad | Pakistan |
| Instituto Oncológico National | Panama City | Panama |
| Instituto Nacional de Enfermadades Neoplasicas Depto. De Radioterapia | Lima | Peru |
| University of Witwatersrand Johannesburg Hospital Dept of Radiation Oncology | Johannesburg | South Africa |
| Institut de la Sante Publique, Institut National de Cancer Salah Azaiz | Tunis | Tunisia |
| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| D008175 | Lung Neoplasms |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| D011827 | Radiation |
| D004358 | Drug Therapy |
| D011878 | Radiotherapy |
| ID | Term |
|---|---|
| D055585 | Physical Phenomena |
| D013812 | Therapeutics |
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