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

Primary Purpose

Non Small Cell Lung Cancer

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
radiation
Chemotherapy and radiotherapy
Chemotherapy
Palliative radiotherapy and chemotherapy
Sponsored by
International Atomic Energy Agency
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Non Small Cell Lung Cancer focused on measuring lung cancer, nonsmall cell lung cancer, radiation therapy, chemotherapy, Locally advanced and metastatic nonsmall cell lung cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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 (?)

Sites / Locations

  • Instituto de Radiomedicine
  • Affiliated Hospital of Ning Xia Medical College, Department of Radiation Oncology
  • University of Zagreb Faculty of Medicine
  • Misr Oncology Center (MOC)
  • Tata Memorial Centre (TMC) Department of Atomic Energy (DAE)
  • General Hospital Kuala Lumpur, Institute of Radiotherapy and Oncology
  • Sir Paul Boffa Hospital
  • Ministère de la Santé, Institut National d'Oncologie Sidi Mohamed Ben Abdellah
  • Nuclear Medicine Oncology and Radiotherapy Institute
  • Instituto Oncológico National
  • Instituto Nacional de Enfermadades Neoplasicas Depto. De Radioterapia
  • University of Witwatersrand Johannesburg Hospital Dept of Radiation Oncology
  • Institut de la Sante Publique, Institut National de Cancer Salah Azaiz

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Experimental

Active Comparator

Experimental

Arm Label

Radiotherapy

Chemotherapy and radiotherapy

Chemotherapy

Palliative radiotherapy and chemotherapy

Arm Description

For patients in Group A (Stage IIIA or IIIB), EBRT 39 Gy in 13 daily fractions over, with no chemotherapy.

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.

For patients in Group B (either stage IIIB (wet) or IV) receive up to 3 cycles of chemotherapy, and no radiotherapy.

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.

Outcomes

Primary Outcome Measures

Survival

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)
To assess the differences in Health Related Quality of Life (HRQoL) of two treatment options in both Study A and Study B

Full Information

First Posted
March 17, 2009
Last Updated
August 6, 2013
Sponsor
International Atomic Energy Agency
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1. Study Identification

Unique Protocol Identification Number
NCT00864331
Brief Title
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

2. Study Status

Record Verification Date
August 2013
Overall Recruitment Status
Completed
Study Start Date
February 2008 (undefined)
Primary Completion Date
November 2012 (Actual)
Study Completion Date
November 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
International Atomic Energy Agency

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non Small Cell Lung Cancer
Keywords
lung cancer, nonsmall cell lung cancer, radiation therapy, chemotherapy, Locally advanced and metastatic nonsmall cell lung cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
251 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Radiotherapy
Arm Type
Active Comparator
Arm Description
For patients in Group A (Stage IIIA or IIIB), EBRT 39 Gy in 13 daily fractions over, with no chemotherapy.
Arm Title
Chemotherapy and radiotherapy
Arm Type
Experimental
Arm Description
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.
Arm Title
Chemotherapy
Arm Type
Active Comparator
Arm Description
For patients in Group B (either stage IIIB (wet) or IV) receive up to 3 cycles of chemotherapy, and no radiotherapy.
Arm Title
Palliative radiotherapy and chemotherapy
Arm Type
Experimental
Arm Description
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 Type
Radiation
Intervention Name(s)
radiation
Intervention Description
39 Gy in 13 daily fractions of 3 Gy
Intervention Type
Other
Intervention Name(s)
Chemotherapy and radiotherapy
Intervention Description
Chemotherapy followed by low dose palliative radiotherapy
Intervention Type
Drug
Intervention Name(s)
Chemotherapy
Intervention Description
Chemotherapy given alone
Intervention Type
Other
Intervention Name(s)
Palliative radiotherapy and chemotherapy
Intervention Description
Low dose palliative radiotherapy followed by chemotherapy
Primary Outcome Measure Information:
Title
Survival
Time Frame
1 year
Secondary Outcome Measure Information:
Title
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
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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 (?)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Elena Fidarova, MD
Organizational Affiliation
International Atomic Energy Agency
Official's Role
Principal Investigator
Facility Information:
Facility Name
Instituto de Radiomedicine
City
Santiago
Country
Chile
Facility Name
Affiliated Hospital of Ning Xia Medical College, Department of Radiation Oncology
City
Yinchuan
Country
China
Facility Name
University of Zagreb Faculty of Medicine
City
Zagreb
Country
Croatia
Facility Name
Misr Oncology Center (MOC)
City
Cairo
Country
Egypt
Facility Name
Tata Memorial Centre (TMC) Department of Atomic Energy (DAE)
City
Mumbai
Country
India
Facility Name
General Hospital Kuala Lumpur, Institute of Radiotherapy and Oncology
City
Kuala Lumpur
Country
Malaysia
Facility Name
Sir Paul Boffa Hospital
City
Floriana
Country
Malta
Facility Name
Ministère de la Santé, Institut National d'Oncologie Sidi Mohamed Ben Abdellah
City
Rabat
Country
Morocco
Facility Name
Nuclear Medicine Oncology and Radiotherapy Institute
City
Islamabad
Country
Pakistan
Facility Name
Instituto Oncológico National
City
Panama City
Country
Panama
Facility Name
Instituto Nacional de Enfermadades Neoplasicas Depto. De Radioterapia
City
Lima
Country
Peru
Facility Name
University of Witwatersrand Johannesburg Hospital Dept of Radiation Oncology
City
Johannesburg
Country
South Africa
Facility Name
Institut de la Sante Publique, Institut National de Cancer Salah Azaiz
City
Tunis
Country
Tunisia

12. IPD Sharing Statement

Citations:
PubMed Identifier
26163093
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.
Results Reference
derived

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

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