Non Small Cell Lung CancerPhase 3NCT00864331
Optimization of Treatment of Advanced Nonsmall Cell Lung Cancer Using Radiotherapy and Chemotherapy
A Phase 3 study testing radiation, Chemotherapy and radiotherapy and Chemotherapy in people with Non Small Cell Lung Cancer, run by International Atomic Energy Agency at 13 sites in 13 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non Small Cell Lung Cancer
- What is being tested?
- radiation, Chemotherapy and radiotherapy and Chemotherapy
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 251 participants
- Where
- 13 sitesin 13 countries
- Study dates
- Feb 2008to Nov 2012
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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 (?)
Trial locations and contacts
13 sites in 13 countries.
13 sites in 13 countries
China1 site
Affiliated Hospital of Ning Xia Medical College, Department of Radiation Oncology
Yinchuan
Malaysia1 site
General Hospital Kuala Lumpur, Institute of Radiotherapy and Oncology
Kuala Lumpur
Morocco1 site
Ministère de la Santé, Institut National d'Oncologie Sidi Mohamed Ben Abdellah
Rabat
Pakistan1 site
Nuclear Medicine Oncology and Radiotherapy Institute
Islamabad
Peru1 site
Instituto Nacional de Enfermadades Neoplasicas Depto. De Radioterapia
Lima
South Africa1 site
University of Witwatersrand Johannesburg Hospital Dept of Radiation Oncology
Johannesburg
Tunisia1 site
Institut de la Sante Publique, Institut National de Cancer Salah Azaiz
Tunis
About this study
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
Read the 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
- Conditions
- Non Small Cell Lung Cancer
- Being tested
- radiation, Chemotherapy and radiotherapy, Chemotherapy, Palliative radiotherapy and chemotherapy
- Keywords
- lung cancer, nonsmall cell lung cancer, radiation therapy, chemotherapy, Locally advanced and metastatic nonsmall cell lung cancer
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung, Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
radiationRadiation
39 Gy in 13 daily fractions of 3 Gy
Chemotherapy and radiotherapyOther
Chemotherapy followed by low dose palliative radiotherapy
ChemotherapyDrug
Chemotherapy given alone
Palliative radiotherapy and chemotherapyOther
Low dose palliative radiotherapy followed by chemotherapy
| Study group | Role | What they receive |
|---|---|---|
| Radiotherapy | Active comparator | For patients in Group A (Stage IIIA or IIIB), EBRT 39 Gy in 13 daily fractions over, with no chemotherapy. Receives: Radiation: radiation |
| Chemotherapy and radiotherapy | Experimental | 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. Receives: Other: Chemotherapy and radiotherapy |
| Chemotherapy | Active comparator | For patients in Group B (either stage IIIB (wet) or IV) receive up to 3 cycles of chemotherapy, and no radiotherapy. Receives: Drug: Chemotherapy |
| Palliative radiotherapy and chemotherapy | Experimental | 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. Receives: Other: Palliative radiotherapy and chemotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Survival
Measured: 1 year
Secondary outcomes (2)
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)
Measured: 1 year
To assess the differences in Health Related Quality of Life (HRQoL) of two treatment options in both Study A and Study B
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2009 (estimated)
- Study startFeb 2008
- Primary completionNov 2012
- Study completionNov 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Non Small Cell Lung CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 251 participants (actual)
Sponsor and investigators
- Lead sponsor
- International Atomic Energy Agency
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Elena Fidarova, MD, Principal investigator, International Atomic Energy Agency
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00864331
- Sponsor's protocol ID
- E33029
- Status last verified
- Aug 2013
- First submitted
- 17 Mar 2009
- Last updated
- 7 Aug 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 26163093
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimization of Treatment of Advanced Nonsmall Cell Lung Cancer Using Radiotherapy and Chemotherapy
- ClinicalTrials.gov ID
- NCT00864331
- Acronym / sponsor ID
- E33029
- Conditions
- Non Small Cell Lung Cancer
- Keywords
- lung cancer, nonsmall cell lung cancer, radiation therapy, chemotherapy, Locally advanced and metastatic nonsmall cell lung cancer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 251 participants (actual)
- Lead sponsor
- International Atomic Energy AgencyOther government
- Study start
- Feb 2008
- Primary completion
- Nov 2012 (actual)
- Study completion
- Nov 2012 (actual)
- First posted
- 18 Mar 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Radiotherapy | Active comparator | Radiation: radiationFor patients in Group A (Stage IIIA or IIIB), EBRT 39 Gy in 13 daily fractions over, with no chemotherapy. |
| Chemotherapy and radiotherapy | Experimental | Other: Chemotherapy and radiotherapyFor 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. |
| Chemotherapy | Active comparator | Drug: ChemotherapyFor patients in Group B (either stage IIIB (wet) or IV) receive up to 3 cycles of chemotherapy, and no radiotherapy. |
| Palliative radiotherapy and chemotherapy | Experimental | Other: Palliative radiotherapy and chemotherapyFor 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| radiation39 Gy in 13 daily fractions of 3 Gy | Radiation | Radiotherapy |
| Chemotherapy and radiotherapyChemotherapy followed by low dose palliative radiotherapy | Other | Chemotherapy and radiotherapy |
| ChemotherapyChemotherapy given alone | Drug | Chemotherapy |
| Palliative radiotherapy and chemotherapyLow dose palliative radiotherapy followed by chemotherapy | Other | Palliative radiotherapy and chemotherapy |
Primary outcome
Survival
Time frame: 1 year
2 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2013.
- Derived from this study: PubMed 26163093Jeremic 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Elena Fidarova, MD principal investigator
International Atomic Energy Agency
13 sites in 13 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing radiation, Chemotherapy and radiotherapy and Chemotherapy in people with Non Small Cell Lung Cancer, run by International Atomic Energy Agency at 13 sites in 13 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Aug 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in Chile, China, Croatia, Egypt, India and 8 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Survival (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00864331, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Aug 2013.