Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
International Atomic Energy Agency
ClinicalTrials.gov Identifier:
NCT00864331
First received: March 17, 2009
Last updated: August 6, 2013
Last verified: August 2013

March 17, 2009
August 6, 2013
February 2008
November 2012   (final data collection date for primary outcome measure)
Survival [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00864331 on ClinicalTrials.gov Archive Site
  • 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 ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Optimization of Treatment of Advanced Nonsmall Cell Lung Cancer Using Radiotherapy and Chemotherapy
Optimization of Treatment of Advanced Nonsmall Cell Lung Cancer Using Radiotherapy and Chemotherapy

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

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Non Small Cell Lung Cancer
  • 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
  • Active Comparator: Radiotherapy
    For patients in Group A (Stage IIIA or IIIB), EBRT 39 Gy in 13 daily fractions over, with no chemotherapy.
    Intervention: Radiation: radiation
  • Experimental: 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.
    Intervention: Other: Chemotherapy and radiotherapy
  • Active Comparator: Chemotherapy
    For patients in Group B (either stage IIIB (wet) or IV) receive up to 3 cycles of chemotherapy, and no radiotherapy.
    Intervention: Drug: Chemotherapy
  • Experimental: 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.
    Intervention: Other: Palliative radiotherapy and chemotherapy
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
251
November 2012
November 2012   (final data collection date for primary outcome measure)

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 (?)
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Chile,   China,   Croatia,   Egypt,   India,   Malaysia,   Malta,   Morocco,   Pakistan,   Panama,   Peru,   South Africa,   Tunisia
 
NCT00864331
E33029
Yes
International Atomic Energy Agency
International Atomic Energy Agency
Not Provided
Principal Investigator: Elena Fidarova, MD International Atomic Energy Agency
International Atomic Energy Agency
August 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP