Non-small Cell Lung CancerPhase 2TARLALNCT00888511
Tarceva And Radiotherapy in Locally Advanced Lung Cancer Non-small Cell Lung Cancer
A Phase 2 study testing Tarceva and Radiotherapy in people with Non-small Cell Lung Cancer, run by Olfred Hansen at 7 sites in Denmark.
Trial summary
The trial is a phase II study of daily Tarceva combined with definitive radiotherapy in inoperable locally advanced non small cell lung cancer (stage IIB-IIIB). The objective of the phase II trial is to examine Tarceva concomitant with curatively intended irradiation 66 Gy (2 Gy x 33 F, 5 F per week). Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Non-small Cell Lung Cancer
- What is being tested?
- Tarceva and Radiotherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 7 sitesDenmark
- Study dates
- May 2009to May 2016
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥18 years
- Patients with histologically or cytologically documented diagnosis locally advanced NSCLC stage IIB to IIIB without pleural effusion
- Performance status ≤2 on the ECOG scale
- Serum bilirubin must be ≤1.5 upper limit of normal (ULN)
- ALAT ≤2 x ULN
- Able to comply with study and follow-up procedures
- Patients with reproductive potential must use effective contraception
- Written (signed) informed consent to participate in the study
Who cannot join
- Any unstable systemic disease (including active infection, unstable angina, congestive heart failure, severe hepatic, renal, or metabolic disease)
- Any other malignancies within 5 years (except for adequately treated carcinoma in situ of the cervix or basal or squamous cell skin cancer)
- Inability to take oral medication, or requirement of intravenous alimentation
- Nursing mothers
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
Denmark7 sites
Department of Oncology, Aarhus University Hospital
Aarhus, 8000
Department of Oncology, Rigshospitalet
Copenhagen, 2100
Department of Oncology, Copenhagen University Hospital at Herlev
Herlev, 270
Department of Oncology, Naestved Hospital
Næstved
Laboratory of Radiation Physics
Odense, 5000
Odense University Hospital
Odense, 5000
Department of Oncology, Vejle Hospital
Vejle, 7100
About this study
Official title: Concomitant Tarceva® and Irradiation in Patients in Local-regionally Advanced Non-small Cell Lung Cancer. A Phase II Study
The trial is a phase II study of daily Tarceva combined with definitive radiotherapy in inoperable locally advanced non small cell lung cancer (stage IIB-IIIB). The objective of the phase II trial is to examine Tarceva concomitant with curatively intended irradiation 66 Gy (2 Gy x 33 F, 5 F per week).
- Conditions
- Non-small Cell Lung Cancer
- Being tested
- Tarceva, Radiotherapy
- Keywords
- Lung cancer, Non-small cell lung cancer, Tarceva, Radiotherapy, Local-regionally advanced non-small 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.
TarcevaDrug
Tarceva 150 mg/day
RadiotherapyRadiation
66 Gy/33 F/5 F per week for 5 weeks
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Drug: Tarceva; Radiation: Radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression Free Survival
Progression free survival from registration according to RECIST 1.1
Measured: 3 years
Secondary outcomes (7)
Toxicity
Measured: 3 years
Local Tumor Control by CT-scan
Measured: May 2012
Overall Response Rate (CR + PR)
Measured: May 2012
Local Tumor Control at 9 Months Evaluated by PET-CT
Measured: May 2012
Overall Survival
Measured: May 2012
Disease Free Survival
Measured: May 2012
Late Toxicity
Measured: May 2012
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2009 (estimated)
- Study startMay 2009
- Primary completionMay 2016
- Study completionMay 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Olfred Hansen
- Sponsor type
- University, hospital or other
- Collaborators
- Odense University Hospital, Copenhagen University Hospital at Herlev, Copenhagen University Hospital, Rigshospitalet, Aalborg University Hospital, Aarhus University Hospital, Naestved Hospital
- Responsible party
- Sponsor-investigator, Olfred Hansen, Odense University Hospital
- Investigators
- Olfred Hansen, MD, Principal investigator, Odense University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00888511
- Sponsor's protocol ID
- 09.02
- Acronym
- TARLAL
- Status last verified
- Nov 2020
- First submitted
- 24 Apr 2009
- Last updated
- 27 Nov 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Concomitant Tarceva® and Irradiation in Patients in Local-regionally Advanced Non-small Cell Lung Cancer. A Phase II Study
- ClinicalTrials.gov ID
- NCT00888511
- Acronym / sponsor ID
- TARLAL / 09.02
- Conditions
- Non-small Cell Lung Cancer
- Keywords
- Lung cancer, Non-small cell lung cancer, Tarceva, Radiotherapy, Local-regionally advanced non-small cell lung cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Olfred HansenUniversity, hospital or other
- Collaborators
- Odense University Hospital, Copenhagen University Hospital at Herlev, Copenhagen University Hospital, Rigshospitalet, Aalborg University Hospital, Aarhus University Hospital, Naestved Hospital
- Study start
- May 2009
- Primary completion
- May 2016 (actual)
- Study completion
- May 2016 (actual)
- First posted
- 27 Apr 2009 (estimated)
- Results
- Posted 27 Nov 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The trial is a phase II study of daily Tarceva combined with definitive radiotherapy in inoperable locally advanced non small cell lung cancer (stage IIB-IIIB). The objective of the phase II trial is to examine Tarceva concomitant with curatively intended irradiation 66 Gy (2 Gy x 33 F, 5 F per week).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Tarceva, Radiation: Radiotherapy |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Age ≥18 years
- Patients with histologically or cytologically documented diagnosis locally advanced NSCLC stage IIB to IIIB without pleural effusion
- Performance status ≤2 on the ECOG scale
- Serum bilirubin must be ≤1.5 upper limit of normal (ULN)
- ALAT ≤2 x ULN
Key exclusion criteria (4 listed)
- Any unstable systemic disease (including active infection, unstable angina, congestive heart failure, severe hepatic, renal, or metabolic disease)
- Any other malignancies within 5 years (except for adequately treated carcinoma in situ of the cervix or basal or squamous cell skin cancer)
- Inability to take oral medication, or requirement of intravenous alimentation
- Nursing mothers
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 |
|---|---|---|
| TarcevaTarceva 150 mg/day | Drug | 1 |
| Radiotherapy66 Gy/33 F/5 F per week for 5 weeks | Radiation | 1 |
Primary outcome
Progression Free Survival
Time frame: 3 years
Progression free survival from registration according to RECIST 1.1
7 secondary outcomes
Toxicity
Time frame: 3 years
Local Tumor Control by CT-scan
Time frame: May 2012
Overall Response Rate (CR + PR)
Time frame: May 2012
Local Tumor Control at 9 Months Evaluated by PET-CT
Time frame: May 2012
Overall Survival
Time frame: May 2012
Disease Free Survival
Time frame: May 2012
Late Toxicity
Time frame: May 2012
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Nov 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Olfred Hansen, MD principal investigator
Odense University Hospital
7 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 Tarceva and Radiotherapy in people with Non-small Cell Lung Cancer, run by Olfred Hansen at 7 sites in Denmark.
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 8 inclusion and 4 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 27 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Denmark. 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?
Yes. Results are posted in the registry (first posted 27 Nov 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Progression Free Survival (time frame: 3 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 27 Nov 2020.