Clinical trial NCT00864331: Optimization of Treatment of Advanced Nonsmall Cell Lung Cancer Using Radiotherapy and Chemotherapy
Official title: Optimization of Treatment of Advanced Nonsmall Cell Lung Cancer Using Radiotherapy and Chemotherapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Non Small Cell Lung Cancer
Keywords: lung cancer
nonsmall cell lung cancer
radiation therapy
chemotherapy
Locally advanced and metastatic nonsmall cell lung cancer
Lead sponsor: International Atomic Energy Agency
Sponsor class: OTHER_GOV
First posted: 2009-03-18
Enrollment: 251
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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) 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: 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

Eligibility criteria: 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 (?)

Primary outcomes:
measure: Survival
timeFrame: 1 year
Secondary outcomes:
measure: 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)
timeFrame: 1 year
measure: To assess the differences in Health Related Quality of Life (HRQoL) of two treatment options in both Study A and Study B
timeFrame: 1 year
Other outcomes:
Locations:
city: Santiago
country: Chile
facility: Instituto de Radiomedicine
city: Yinchuan
country: China
facility: Affiliated Hospital of Ning Xia Medical College, Department of Radiation Oncology
city: Zagreb
country: Croatia
facility: University of Zagreb Faculty of Medicine
city: Cairo
country: Egypt
facility: Misr Oncology Center (MOC)
city: Mumbai
country: India
facility: Tata Memorial Centre (TMC) Department of Atomic Energy (DAE)
city: Kuala Lumpur
country: Malaysia
facility: General Hospital Kuala Lumpur, Institute of Radiotherapy and Oncology
city: Floriana
country: Malta
facility: Sir Paul Boffa Hospital
city: Rabat
country: Morocco
facility: Ministère de la Santé, Institut National d'Oncologie Sidi Mohamed Ben Abdellah
city: Islamabad
country: Pakistan
facility: Nuclear Medicine Oncology and Radiotherapy Institute
city: Panama City
country: Panama
facility: Instituto Oncológico National
city: Lima
country: Peru
facility: Instituto Nacional de Enfermadades Neoplasicas Depto. De Radioterapia
city: Johannesburg
country: South Africa
facility: University of Witwatersrand Johannesburg Hospital Dept of Radiation Oncology
city: Tunis
country: Tunisia
facility: Institut de la Sante Publique, Institut National de Cancer Salah Azaiz
Study officials:
affiliation: International Atomic Energy Agency
name: Elena Fidarova, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.