Non-small Cell Lung CancerPhase 2NCT00391248
Phase II Trial of Erlotinib and Concurrent Palliative Thoracic Radiation Therapy for Non-small Cell Lung Cancer (PEARL)
A Phase 2 study testing Erlotinib in people with Non-small Cell Lung Cancer, run by Ontario Clinical Oncology Group (OCOG) at 2 sites in Canada.
Trial summary
To improve the clinical outcomes of patients with non-small cell lung cancer treated with radiation therapy. 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?
- Erlotinib
- How many people
- 40 participants
- Where
- 2 sitesCanada
- Study dates
- Nov 2006to Dec 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
- Histologically confirmed non-small cell lung cancer (squamous cell, adenocarcinoma, poorly differentiated non-small cell carcinoma, or some combination of these); and
- Symptomatic patients (defined at discretion of investigator) for whom palliative thoracic radiation is planned (3000cGy/10 fractions); and
- At least 18 years of age.
Who cannot join
- Previous erlotinib therapy; or
- Planned concurrent chemotherapy; or
- Expected survival of less than 3 months; or
- ECOG Performance Status of 3 or 4; or
- Multiple CNS metastasis or a single CNS lesion that has not demonstrated radiologic stability (screening CT/MRI or head not required); or
- Granulocyte count <1,500/mm3, platelet count <100,000/mm3, or haemoglobin <9.0g/dl; or
Show all 20Show fewer
- SGOT (AST) or SGPT (ALT) > 2.5 times (x) upper limit of normal (ULN) in the absence of known liver metastases or > 5 x ULN in case of known liver metastases; or
- Alkaline phosphatase (ALP) > 2.5 x ULN; or
- Serum bilirubin > 1.5 ULN; or
- Serum creatinine > 1.5 ULN or creatinine clearance < 60 ml/min; or
- Serum calcium beyond ULN; or
- Patients requiring systemic anti-fungal therapy, clarithromycin, phenytoin, or oral anticoagulation therapy (see Appendix VI for complete list of medications); or
- A history of interstitial lung disease; or
- Known sensitivity to erlotinib; or
- Pregnancy, lactation, or parturition within the previous 30 days; or
- Unwillingness or inability to complete the required assessments of the trial; or
- Mental incompetence, including psychiatric or addictive disorders which would preclude meaningful informed consent; or
- History of recurrent conjunctivitis or keratitis or other inflammatory changes of the surface of the eye.
- Geographically inaccessible for treatment or follow-up evaluations; or
- Involved in an ongoing therapeutic trial.
Trial locations and contacts
2 sites in 1 country.
Canada2 sites
Juravinski Cancer Centre
Hamilton, Ontario, L8V 1C3
Toronto Sunnybrook Regional Cancer Centre
Toronto, Ontario, M5N 3M5
About this study
Official title: A Phase II Trial of Erlotinib and Concurrent Palliative Thoracic Radiation Therapy for Patients With Non-small Cell Carcinoma of the Lung. (PEARL Trial)
To improve the clinical outcomes of patients with non-small cell lung cancer treated with radiation therapy.
- Conditions
- Non-small Cell Lung Cancer
- Being tested
- Erlotinib
- Keywords
- non-small cell lung cancer, palliative radiation, tarceva, palliative thoracic radiation therapy
- 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.
ErlotinibDrug
Also called Tarceva
150 mg in a single daily dose, starting Day 1 through Day 22
What is being measured
The primary outcome is the main question the study is designed to answer.
The mean improvement of "lung cancer symptoms" as measured by the Lung Cancer Symptom Scale at four weeks following completion of radiation therapy
Measured: 4 weeks post radiotherapy
Secondary outcomes (1)
The improvement in global quality of life and total scores of the LCSS at four weeks following treatment, radiological response, and the incidence and severity of adverse events as per the CTCAE version 3
Measured: 4 weeks post radiotherapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2006 (estimated)
- Study startNov 2006
- Primary completionDec 2012
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ontario Clinical Oncology Group (OCOG)
- Sponsor type
- University, hospital or other
- Collaborators
- Roche Pharma AG
- Responsible party
- Sponsor
- Investigators
- Jim Wright, MD, Principal investigator, Juravinski Cancer Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00391248
- Sponsor's protocol ID
- CTA-Control-105472
- Status last verified
- Apr 2011
- First submitted
- 19 Oct 2006
- Last updated
- 29 Jan 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Trial of Erlotinib and Concurrent Palliative Thoracic Radiation Therapy for Patients With Non-small Cell Carcinoma of the Lung. (PEARL Trial)
- ClinicalTrials.gov ID
- NCT00391248
- Acronym / sponsor ID
- CTA-Control-105472
- Conditions
- Non-small Cell Lung Cancer
- Keywords
- non-small cell lung cancer, palliative radiation, tarceva, palliative thoracic radiation therapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Ontario Clinical Oncology Group (OCOG)University, hospital or other
- Collaborators
- Roche Pharma AG
- Study start
- Nov 2006
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 23 Oct 2006 (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.
To improve the clinical outcomes of patients with non-small cell lung cancer treated with radiation therapy.
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 (3 listed)
- Histologically confirmed non-small cell lung cancer (squamous cell, adenocarcinoma, poorly differentiated non-small cell carcinoma, or some combination of these); and
- Symptomatic patients (defined at discretion of investigator) for whom palliative thoracic radiation is planned (3000cGy/10 fractions); and
- At least 18 years of age.
Key exclusion criteria (20 listed)
- Previous erlotinib therapy; or
- Planned concurrent chemotherapy; or
- Expected survival of less than 3 months; or
- ECOG Performance Status of 3 or 4; or
- Multiple CNS metastasis or a single CNS lesion that has not demonstrated radiologic stability (screening CT/MRI or head not required); or
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 |
|---|---|---|
| ErlotinibAlso: Tarceva150 mg in a single daily dose, starting Day 1 through Day 22 | Drug | – |
Primary outcome
The mean improvement of "lung cancer symptoms" as measured by the Lung Cancer Symptom Scale at four weeks following completion of radiation therapy
Time frame: 4 weeks post radiotherapy
1 secondary outcome
The improvement in global quality of life and total scores of the LCSS at four weeks following treatment, radiological response, and the incidence and severity of adverse events as per the CTCAE version 3
Time frame: 4 weeks post radiotherapy
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 29 Jan 2013.
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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.
Jim Wright, MD principal investigator
Juravinski Cancer Centre
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 Erlotinib in people with Non-small Cell Lung Cancer, run by Ontario Clinical Oncology Group (OCOG) at 2 sites in Canada.
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 3 inclusion and 20 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: finished, as of the sponsor's last update on 29 Jan 2013. 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 Canada. 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 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?
The mean improvement of "lung cancer symptoms" as measured by the Lung Cancer Symptom Scale at four weeks following completion of radiation therapy (time frame: 4 weeks post radiotherapy). 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 29 Jan 2013.