Early Stage Non-small Cell Lung CancerPhase 2PEARL-1NCT01138722
Predicting Cell Death by Radiation Therapy in Early Stage Non-small Cell Lung Cancer: a Prospective Translational Trial
A Phase 2 study testing hypofractionated radiation therapy followed by surgery in people with Early Stage Non-small Cell Lung Cancer, run by University Hospital, Ghent at 2 sites 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
- Early Stage Non-small Cell Lung Cancer
- What is being tested?
- hypofractionated radiation therapy followed by surgery
- Type of treatment
- Surgery or procedure
- How many people
- 1 participants
- Where
- 2 sitesBelgium
- Study dates
- May 2010to Aug 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 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
- Operable patient
- > 18 years old
- men and women
Who cannot join
None listed.
Trial locations and contacts
2 sites in 1 country.
Belgium2 sites
University Hospital Antwerp
Antwerp
University Hospital Ghent
Ghent
About this study
Official title: Pathologic Effects of Neoadjuvant Radiation Therapy in Operable Early Stage Lung Cancer
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 relationship between blood and tissue biomarkers, bio-imaging and pathology in patients with early stage NSCLC treated with hypofractionated radiation therapy and surgery.
- Conditions
- Early Stage Non-small Cell Lung Cancer
- Being tested
- hypofractionated radiation therapy followed by surgery
- Keywords
- early stage non-small cell lung cancer, hypofractionated radiation therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
hypofractionated radiation therapy followed by surgeryRadiation
hypofractionated radiation therapy followed by surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
pathological effects of hypofractionated radiation therapy
To describe the pathological effects of hypofractionated radioation therapy (RT) and to address the relationship with blood and tissue biomarkers and bio-imaging.
Measured: at 2 years
Secondary outcomes (7)
clinical response rate
Measured: from 2 to 5 years
the accuracy of clinical mediastinal staging
Measured: from 2 to 5 years
the 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
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 startMay 2010
- Primary completionAug 2011
- Study completionAug 2011
Why it stopped: Poor recruitment rate.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- 1 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, Belgium
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01138722
- Sponsor's protocol ID
- 2010/204
- Other IDs
- LONG 10-01
- Acronym
- PEARL-1
- Status last verified
- Jul 2021
- First submitted
- 4 Jun 2010
- Last updated
- 8 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pathologic Effects of Neoadjuvant Radiation Therapy in Operable Early Stage Lung Cancer
- ClinicalTrials.gov ID
- NCT01138722
- Acronym / sponsor ID
- PEARL-1 / 2010/204
- Conditions
- Early Stage Non-small Cell Lung Cancer
- Keywords
- early stage non-small cell lung cancer, hypofractionated radiation therapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Poor recruitment rate.
- Enrolment
- 1 participants (actual)
- Lead sponsor
- University Hospital, GhentUniversity, hospital or other
- Collaborators
- Nationaal Kankerplan
- Study start
- May 2010
- Primary completion
- Aug 2011 (actual)
- Study completion
- Aug 2011 (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 relationship between blood and tissue biomarkers, bio-imaging and pathology in patients with early stage NSCLC treated with hypofractionated radiation therapy and surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Proof of cT1a/b - 2a/b N0M0 NSCLC
- Informed Consent signed
- Resectable tumour
- Operable patient
- > 18 years old
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 therapy followed by surgeryhypofractionated radiation therapy followed by surgery | Radiation | – |
Primary outcome
pathological effects of hypofractionated radiation therapy
Time frame: at 2 years
To describe the pathological effects of hypofractionated radioation therapy (RT) and to address the relationship with blood and tissue biomarkers and bio-imaging.
7 secondary outcomes
clinical response rate
Time frame: from 2 to 5 years
the accuracy of clinical mediastinal staging
Time frame: from 2 to 5 years
the 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
overall survival
Time frame: from 2 to 5 years
Results and safety
The study was stopped early (reason given: Poor recruitment rate.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2021.
- 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, Belgium
2 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 hypofractionated radiation therapy followed by surgery in people with Early Stage Non-small Cell Lung Cancer, run by University Hospital, Ghent at 2 sites 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 6 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 8 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 (reason given: Poor recruitment rate.). 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?
pathological effects of hypofractionated radiation therapy (time frame: at 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 8 Jul 2021.