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

August 6, 2013 updated by: International Atomic Energy Agency

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Actual)

251

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Survival
Time Frame: 1 year
1 year

Secondary Outcome Measures

Outcome Measure
Time Frame
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
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
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

International Atomic Energy Agency

Investigators

  • Principal Investigator: Elena Fidarova, MD, International Atomic Energy Agency

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2008

Primary Completion (Actual)

November 1, 2012

Study Completion (Actual)

November 1, 2012

Study Registration Dates

First Submitted

March 17, 2009

First Submitted That Met QC Criteria

March 17, 2009

First Posted (Estimate)

March 18, 2009

Study Record Updates

Last Update Posted (Estimate)

August 7, 2013

Last Update Submitted That Met QC Criteria

August 6, 2013

Last Verified

August 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • E33029

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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