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

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT00864331
• Date of registration: 17/03/2009
• Prospective Registration: No
• Primary sponsor: International Atomic Energy Agency
• Public title: Optimization of Treatment of Advanced Nonsmall Cell Lung Cancer Using Radiotherapy and Chemotherapy
• Scientific title: Optimization of Treatment of Advanced Nonsmall Cell Lung Cancer Using Radiotherapy and Chemotherapy
• Date of first enrolment: February 2008
• Target sample size: 251
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00864331
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
• Phase: Phase 3

Countries of recruitment

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

Contacts

• Name: Elena Fidarova, MD
• Affiliation: International Atomic Energy Agency

Key inclusion & exclusion 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 (?)



Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Non Small Cell Lung Cancer

Intervention(s)

Other: Chemotherapy and radiotherapy

Radiation: radiation

Other: Palliative radiotherapy and chemotherapy

Drug: Chemotherapy

Primary Outcome(s)

Survival [Time Frame: 1 year]

Secondary Outcome(s)

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) [Time Frame: 1 year]

To assess the differences in Health Related Quality of Life (HRQoL) of two treatment options in both Study A and Study B [Time Frame: 1 year]

Secondary ID(s)

E33029

Source(s) of Monetary Support

Please refer to primary and secondary sponsors