Optimization of Treatment of Advanced Nonsmall Cell Lung Cancer Using Radiotherapy and Chemotherapy
NCT ID: NCT00864331
Last Updated: 2013-08-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
251 participants
INTERVENTIONAL
2008-02-29
2012-11-30
Brief Summary
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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 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
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Radiotherapy
For patients in Group A (Stage IIIA or IIIB), EBRT 39 Gy in 13 daily fractions over, with no chemotherapy.
radiation
39 Gy in 13 daily fractions of 3 Gy
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.
Chemotherapy and radiotherapy
Chemotherapy followed by low dose palliative radiotherapy
Chemotherapy
For patients in Group B (either stage IIIB (wet) or IV) receive up to 3 cycles of chemotherapy, and no radiotherapy.
Chemotherapy
Chemotherapy given alone
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.
Palliative radiotherapy and chemotherapy
Low dose palliative radiotherapy followed by chemotherapy
Interventions
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radiation
39 Gy in 13 daily fractions of 3 Gy
Chemotherapy and radiotherapy
Chemotherapy followed by low dose palliative radiotherapy
Chemotherapy
Chemotherapy given alone
Palliative radiotherapy and chemotherapy
Low dose palliative radiotherapy followed by chemotherapy
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
Exclusion Criteria
* RT field \> 200 cm2
* Pregnancy
* 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 (?)
18 Years
ALL
No
Sponsors
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International Atomic Energy Agency
OTHER_GOV
Responsible Party
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Principal Investigators
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Elena Fidarova, MD
Role: PRINCIPAL_INVESTIGATOR
International Atomic Energy Agency
Locations
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Instituto de Radiomedicine
Santiago, , Chile
Affiliated Hospital of Ning Xia Medical College, Department of Radiation Oncology
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
Countries
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References
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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.
Other Identifiers
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E33029
Identifier Type: -
Identifier Source: org_study_id