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

Non Small Cell Lung Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00864331
• Other study ID #: E33029
• Status: Completed
• Phase: Phase 3
• First received: March 17, 2009
• Last updated: August 6, 2013
• Start date: February 2008
• Est. completion date: November 2012

Study information

• Verified date: August 2013
• Source: International Atomic Energy Agency
• Contact: n/a
• Is FDA regulated: No
• Health authority: Austria: Ethikkommission
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 251
• Est. completion date: November 2012
• Est. primary completion date: November 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Non Small Cell Lung Cancer

Intervention

Radiation:
• radiation
39 Gy in 13 daily fractions of 3 Gy

Other:
• Chemotherapy and radiotherapy
Chemotherapy followed by low dose palliative radiotherapy

Drug:
• Chemotherapy
Chemotherapy given alone

Other:
• Palliative radiotherapy and chemotherapy
Low dose palliative radiotherapy followed by chemotherapy

Locations

Country	Name	City	State
Chile	Instituto de Radiomedicine	Santiago
China	Affiliated Hospital of Ning Xia Medical College, Department of Radiation Oncology	Yinchuan
Croatia	University of Zagreb Faculty of Medicine	Zagreb
Egypt	Misr Oncology Center (MOC)	Cairo
India	Tata Memorial Centre (TMC) Department of Atomic Energy (DAE)	Mumbai
Malaysia	General Hospital Kuala Lumpur, Institute of Radiotherapy and Oncology	Kuala Lumpur
Malta	Sir Paul Boffa Hospital	Floriana
Morocco	Ministère de la Santé, Institut National d'Oncologie Sidi Mohamed Ben Abdellah	Rabat
Pakistan	Nuclear Medicine Oncology and Radiotherapy Institute	Islamabad
Panama	Instituto Oncológico National	Panama City
Peru	Instituto Nacional de Enfermadades Neoplasicas Depto. De Radioterapia	Lima
South Africa	University of Witwatersrand Johannesburg Hospital Dept of Radiation Oncology	Johannesburg
Tunisia	Institut de la Sante Publique, Institut National de Cancer Salah Azaiz	Tunis

Sponsors (1)

Lead Sponsor	Collaborator
International Atomic Energy Agency

Countries where clinical trial is conducted

Chile,  China,  Croatia,  Egypt,  India,  Malaysia,  Malta,  Morocco,  Pakistan,  Panama,  Peru,  South Africa,  Tunisia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Survival		1 year	No
Secondary	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	Yes
Secondary	To assess the differences in Health Related Quality of Life (HRQoL) of two treatment options in both Study A and Study B		1 year	No