Inoperable Early Stage Non-small Cell Lung CancerPhase 2PEARL-2NCT01138748
Prediction of the Effectiveness of Hypofractionated Radiation Therapy in Early Stage Lung Cancer by Bio-imaging and Biomarkers
A Phase 2 study testing hypofractionated radiation therapy in people with Inoperable Early Stage Non-small Cell Lung Cancer, run by University Hospital, Ghent at 1 site in Belgium.
Trial summary
Surgical resection with mediastinal lymph node sampling is currently the therapy of choice for early stage (I-II) non-small cell lung cancer (NSCLC). Selected patients unwilling or unable to tolerate surgery are referred for so-called 'curative' high dose radiotherapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Inoperable Early Stage Non-small Cell Lung Cancer
- What is being tested?
- hypofractionated radiation therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteBelgium
- Study dates
- Nov 2010to Oct 2012
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Proof of cT1a/b - 2a/b N0M0 NSCLC
- Informed Consent signed
- Resectable tumour
- > 18 years old
- men and women
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Surgical resection with mediastinal lymph node sampling is currently the therapy of choice for early stage (I-II) non-small cell lung cancer (NSCLC). Selected patients unwilling or unable to tolerate surgery are referred for so-called 'curative' high dose radiotherapy. This has shown to result in a long term local disease control rate and a high cancer specific survival.
The current trial addresses the issue if progression free survival (PFS) in patients treated with radiotherapy can be predicted by a multi-variate model derived from a composite of bio-imaging and biomarkers
- Being tested
- hypofractionated radiation therapy
- Keywords
- inoperable early stage non-small cell lung cancer, radiation therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
hypofractionated radiation therapyRadiation
hypofractionated radiation therapy
| Study group | Role | What they receive |
|---|---|---|
| Radiation therapy | Experimental | Not described Receives: Radiation: hypofractionated radiation therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
development and validation of a multi-variate predictive model
To develop and validate a multi-variate predictive model based on bio-imaging and biomarkers for progression)free survival from 2 to 5 years.
Measured: from 2 to 5 years
Secondary outcomes (4)
the clinical response and complication rate
Measured: from 2 to 5 years
local, regional or distant failure
Measured: from 2 to 5 years
progression free survival
Measured: from 2 to 5 years
disease specific overall survival
Measured: from 2 to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2010 (estimated)
- Study startNov 2010
- Primary completionOct 2012
- Study completionOct 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Inoperable Early Stage Non-small Cell Lung CancerStudies of the same condition, open and under way.
- More trials run by University Hospital, GhentThe 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Ghent
- Sponsor type
- University, hospital or other
- Collaborators
- Nationaal Kankerplan
- Responsible party
- Sponsor
- Investigators
- Jan Van Meerbeeck, MD,PhD, Principal investigator, University Hospital, Ghent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01138748
- Sponsor's protocol ID
- 2010/205
- Other IDs
- LONG 10-01
- Acronym
- PEARL-2
- Status last verified
- Feb 2013
- First submitted
- 4 Jun 2010
- Last updated
- 4 Feb 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prediction of the Effectiveness of Hypofractionated Radiation Therapy in Early Stage Lung Cancer by Bio-imaging and Biomarkers
- ClinicalTrials.gov ID
- NCT01138748
- Acronym / sponsor ID
- PEARL-2 / 2010/205
- Keywords
- inoperable early stage non-small cell lung cancer, radiation therapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 5 participants (actual)
- Lead sponsor
- University Hospital, GhentUniversity, hospital or other
- Collaborators
- Nationaal Kankerplan
- Study start
- Nov 2010
- Primary completion
- Oct 2012 (actual)
- Study completion
- Oct 2012 (actual)
- First posted
- 7 Jun 2010 (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.
Surgical resection with mediastinal lymph node sampling is currently the therapy of choice for early stage (I-II) non-small cell lung cancer (NSCLC). Selected patients unwilling or unable to tolerate surgery are referred for so-called 'curative' high dose radiotherapy. This has shown to result in a long term local disease control rate and a high cancer specific survival.
The current trial addresses the issue if progression free survival (PFS) in patients treated with radiotherapy can be predicted by a multi-variate model derived from a composite of bio-imaging and biomarkers
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Radiation therapy | Experimental | Radiation: hypofractionated radiation therapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Proof of cT1a/b - 2a/b N0M0 NSCLC
- Informed Consent signed
- Resectable tumour
- > 18 years old
- men and women
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| hypofractionated radiation therapyhypofractionated radiation therapy | Radiation | Radiation therapy |
Primary outcome
development and validation of a multi-variate predictive model
Time frame: from 2 to 5 years
To develop and validate a multi-variate predictive model based on bio-imaging and biomarkers for progression)free survival from 2 to 5 years.
4 secondary outcomes
the clinical response and complication rate
Time frame: from 2 to 5 years
local, regional or distant failure
Time frame: from 2 to 5 years
progression free survival
Time frame: from 2 to 5 years
disease specific overall survival
Time frame: from 2 to 5 years
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2013.
- Website of University Hospital GhentLink provided by the sponsor.
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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.
Jan Van Meerbeeck, MD,PhD principal investigator
University Hospital, Ghent
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing hypofractionated radiation therapy in people with Inoperable Early Stage Non-small Cell Lung Cancer, run by University Hospital, Ghent at 1 site in Belgium.
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 5 inclusion and 0 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: stopped early, as of the sponsor's last update on 4 Feb 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. 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?
The study was stopped early. Results are not available in the source record.
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?
development and validation of a multi-variate predictive model (time frame: from 2 to 5 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 4 Feb 2013.