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
  Purpose

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


Condition Intervention Phase
Non Small Cell Lung Cancer
Radiation: radiation
Other: Chemotherapy and radiotherapy
Drug: Chemotherapy
Other: Palliative radiotherapy and chemotherapy
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Optimization of Treatment of Advanced Nonsmall Cell Lung Cancer Using Radiotherapy and Chemotherapy

Resource links provided by NLM:


Further study details as provided by International Atomic Energy Agency:

Primary Outcome Measures:
  • Survival [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 251
Study Start Date: February 2008
Study Completion Date: November 2012
Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Radiotherapy
For patients in Group A (Stage IIIA or IIIB), EBRT 39 Gy in 13 daily fractions over, with no chemotherapy.
Radiation: radiation
39 Gy in 13 daily fractions of 3 Gy
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.
Other: Chemotherapy and radiotherapy
Chemotherapy followed by low dose palliative 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.
Drug: Chemotherapy
Chemotherapy given alone
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.
Other: Palliative radiotherapy and chemotherapy
Low dose palliative radiotherapy followed by chemotherapy

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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 (?)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00864331

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

Additional Information:
No publications provided

Responsible Party: International Atomic Energy Agency
ClinicalTrials.gov Identifier: NCT00864331     History of Changes
Other Study ID Numbers: E33029
Study First Received: March 17, 2009
Last Updated: August 6, 2013
Health Authority: Austria: Ethikkommission

Keywords provided by International Atomic Energy Agency:
lung cancer
nonsmall cell lung cancer
radiation therapy
chemotherapy
Locally advanced and metastatic nonsmall cell lung cancer

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on April 15, 2014