Stage III Non-Small Cell Lung CancerPhase 2NCT00938418
Hypofractionated Intensity Modulated Chemoradiotherapy to Treat Locally Advanced Non-Small Cell Lung Cancer
A Phase 2 study testing Dose escalated, accelerated, hypofractionated radiotherapy in people with Stage III Non-Small Cell Lung Cancer, run by National University Hospital, Singapore at 3 sites in Singapore.
Trial summary
Locally advanced non-small cell lung cancer can be treated successfully with chemotherapy and radiation. However, the cure rate is low. This study is carried out to find out whether giving radiotherapy at a higher dose over fewer treatment sessions with intensity modulated radiotherapy (IMRT) can improve the treatment… Read more about this study
- Who is it for?
- Ages 21 to 70 years
- Conditions the study is for
- Stage III Non-Small Cell Lung Cancer
- What is being tested?
- Dose escalated, accelerated, hypofractionated radiotherapy
- Type of treatment
- Surgery or procedure
- How many people
- 43 participants
- Where
- 3 sitesSingapore
- Study dates
- Jul 2009to Jul 2011
- Phase
- Phase 2
- 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 21 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Pathologically proven (either histologic or cytologic) diagnosis of Stage IIIA or IIIB non-small cell lung cancer; excluding patients with N3 disease based on supraclavicular or contralateral hilar adenopathy, or significant pleural / pericardial effusion.
Who cannot join
- Patients for whom treatment is planned with a maximum dose of ≥ 66 Gy to the ipsilateral brachial plexus
- Greater than minimal, exudative, or cytologically positive pleural effusions
- ≥ 10% weight loss within the past month
- Prior invasive malignancy (with exceptions)
- Prior radiotherapy to the region of the study cancer
- Significant co-morbidities
- Pregnancy or women of childbearing potential and men who are sexually active and not willing/able to use medically acceptable forms of contraception
- Known allergic reactions to components of planned chemotherapy regimen
Trial locations and contacts
3 sites in 1 country.
Jay Lu, MD contact
Singapore3 sites, 3 recruiting
- Recruiting
National University Hospital
Singapore
- Recruiting
National University Hospital
Singapore
Jay Lu, MD, 6567724870
- Recruiting
Tan Tock Seng Hospital
Singapore
Cheng Nang Leong, MD, 6563571070
Cheng Nang Leong, MD
About this study
Official title: Phase II Study on Dose Escalated, Accelerated Hypofractionated Intensity Modulated Radiotherapy for Stage III Non-Small Cell Lung Cancer With Concurrent Chemotherapy
Locally advanced non-small cell lung cancer can be treated successfully with chemotherapy and radiation. However, the cure rate is low.
This study is carried out to find out whether giving radiotherapy at a higher dose over fewer treatment sessions with intensity modulated radiotherapy (IMRT) can improve the treatment outcome.
This study aims to recruit 43 patients from National University Hospital and Tan Tock Seng Hospital over a period of about 2 years.
- Conditions
- Stage III Non-Small Cell Lung Cancer
- Being tested
- Dose escalated, accelerated, hypofractionated radiotherapy
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dose escalated, accelerated, hypofractionated radiotherapyRadiation
Intensity modulated radiotherapy with concurrent chemotherapy
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival
Measured: 2 years
Secondary outcomes (1)
Response rate, locoregional control, disease free survival, toxicity
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2009 (estimated)
- Study startJul 2009
- Primary completionJul 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stage III Non-Small Cell Lung CancerStudies of the same condition, open and under way.
- More trials run by National University Hospital, SingaporeThe sponsor's other registered studies.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 43 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National University Hospital, Singapore
- Sponsor type
- University, hospital or other
- Collaborators
- Tan Tock Seng Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00938418
- Sponsor's protocol ID
- B/09/108
- Status last verified
- Jul 2009
- First submitted
- 10 Jul 2009
- Last updated
- 13 Jul 2009
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study on Dose Escalated, Accelerated Hypofractionated Intensity Modulated Radiotherapy for Stage III Non-Small Cell Lung Cancer With Concurrent Chemotherapy
- ClinicalTrials.gov ID
- NCT00938418
- Acronym / sponsor ID
- B/09/108
- Conditions
- Stage III Non-Small Cell Lung Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 43 participants (estimated)
- Lead sponsor
- National University Hospital, SingaporeUniversity, hospital or other
- Collaborators
- Tan Tock Seng Hospital
- Study start
- Jul 2009
- Primary completion
- Jul 2011 (estimated)
- First posted
- 13 Jul 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.
Locally advanced non-small cell lung cancer can be treated successfully with chemotherapy and radiation. However, the cure rate is low.
This study is carried out to find out whether giving radiotherapy at a higher dose over fewer treatment sessions with intensity modulated radiotherapy (IMRT) can improve the treatment outcome.
This study aims to recruit 43 patients from National University Hospital and Tan Tock Seng Hospital over a period of about 2 years.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 21 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Pathologically proven (either histologic or cytologic) diagnosis of Stage IIIA or IIIB non-small cell lung cancer; excluding patients with N3 disease based on supraclavicular or contralateral hilar adenopathy, or significant pleural / pericardial effusion.
Key exclusion criteria (8 listed)
- Patients for whom treatment is planned with a maximum dose of ≥ 66 Gy to the ipsilateral brachial plexus
- Greater than minimal, exudative, or cytologically positive pleural effusions
- ≥ 10% weight loss within the past month
- Prior invasive malignancy (with exceptions)
- Prior radiotherapy to the region of the study cancer
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 |
|---|---|---|
| Dose escalated, accelerated, hypofractionated radiotherapyIntensity modulated radiotherapy with concurrent chemotherapy | Radiation | – |
Primary outcome
Overall survival
Time frame: 2 years
1 secondary outcome
Response rate, locoregional control, disease free survival, toxicity
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2009.
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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.
Jay Lu, MD contact
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Dose escalated, accelerated, hypofractionated radiotherapy in people with Stage III Non-Small Cell Lung Cancer, run by National University Hospital, Singapore at 3 sites in Singapore.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 8 exclusion criteria. 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: status not confirmed, as of the sponsor's last update on 13 Jul 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Singapore. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ivan Tham, MD (6567724870, ivan_wk_tham@nuh.com.sg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall survival (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 Jul 2009.