CancerPhase 2ThoRaTNCT02714530
Thoracal Radiotherapy and Tarceva
A Phase 2 study testing Erlotinib and Radiation in people with Cancer, run by Oslo University Hospital at 2 sites in Norway.
Trial summary
The purpose of this study is to determine if erlotinib given orally along with concurrent palliative irradiation to lung cancer improves local control compared to those treated with radiotherapy alone. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer
- What is being tested?
- Erlotinib and Radiation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 118 participants
- Where
- 2 sitesNorway
- Study dates
- 1 Apr 2014to 30 Dec 2020
- 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
- Age >18 years
- Histological or cytological verified NSCLC
- Palliative radiotherapy to thorax indicated
- ECOG Performance status 0-2
- Fertile patients must use contraception
- Signed informed consent
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- Ability to understand and fill in QoL questionnaires
- Capability to take per os medication
- Serum bilirubin < 2 times upper limit of normal (ULN)
- AST and ALT < 2 times ULN (< 5 times ULN if liver metastases are present)
- Creatinine < 5 times ULN
Who cannot join
- Pregnancy or nursing
- Other prior or concurrent malignant disease likely to interfere with study treatment or comparisons
- No evidence of other significant laboratory finding or concurrent uncontrolled medical illness, that in the opinion of the investigator, would interfere with study treatment or results comparison or render the patient at high risk for treatment complications
- No prior radiotherapy to the same organ / place
- No concurrent treatment with other experimental drugs
- Known brain metastases in need of radiotherapy
- Known hypersensitivity to erlotinib or other substances in the erlotinib tablets.
Trial locations and contacts
2 sites in 1 country.
Norway2 sites
Oslo University Hospital
Oslo, International/Other, 0310
St Olavs Hospital
Trondheim, 7010
About this study
Official title: Concomitant Radiotherapy and Erlotinib in Advanced Lung Cancer
The purpose of this study is to determine if erlotinib given orally along with concurrent palliative irradiation to lung cancer improves local control compared to those treated with radiotherapy alone.
Read the detailed description
Endpoints:
Primary:
- To determine if erlotinib given orally along with concurrent external beam radiation therapy, prolongs local tumour control as determined by CT evaluation compared to treatment with external beam radiation therapy alone
Secondary:
- To confirm the safety profile of erlotinib along with concurrent external beam radiation therapy.
- To evaluate if erlotinib along with concurrent external beam radiation therapy, improve quality of life as assessed with the EORTC QLQ-C30 and the EORTC QLQ-LC13.
- To evaluate if PET-CT examination can be used to predict response to treatment.
- To evaluate overall survival in the different groups
Trial Design: Open multicenter two-armed randomized phase II trial.
- Conditions
- Cancer
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ErlotinibDrug
Also called Tarceva
Tarceva daily during radiotherapy course
RadiationRadiation
Radiotherapy
| Study group | Role | What they receive |
|---|---|---|
| Radiotherapy combined with erlotinib | Experimental | Standard treatment 3 Gy x 10 to lung tumor and mediastinal lymph nodes and erlotinib given concomitantly, 150 mg p.o. daily from the day before radiation, until the last day of radiation. Receives: Drug: Erlotinib; Radiation: Radiation |
| Radiotherapy alone | Active comparator | Radiotherapy 3 Gy x 10 alone Receives: Radiation: Radiation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients with progression in radiation field among patients treated with erlotinib combined with radiotherapy compared to radiotherapy alone
Evaluate local control by radiological evaluation
Measured: 1 year
Secondary outcomes (2)
Number of Participants With Treatment-Related Adverse Events grade >3 as Assessed by CTCAE v4.0
To confirm the safety profile of erlotinib along with concurrent external beam radiation therapy.
Measured: 1 year
Overall survival will be measured
To evaluate overall survival in the different groups
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2016 (estimated)
- Study start1 Apr 2014
- Primary completion30 Dec 2020
- Study completion30 Dec 2020
Why it stopped: Slow accrual
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by Oslo University HospitalThe 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 118 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oslo University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Åslaug Helland, Oslo University Hospital
- Investigators
- Åslaug Helland, MD PhD, Principal investigator, Oslo University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02714530
- Sponsor's protocol ID
- ThoRaT
- Acronym
- ThoRaT
- Status last verified
- Mar 2021
- First submitted
- 10 Sep 2015
- Last updated
- 30 Mar 2021
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: Publish results
Publications
Nymoen HM, Alver TN, Horndalsveen H, Eide HA, Bjaanaes MM, Brustugun OT, Gronberg BH, Haakensen VD, Helland A. Thoracic radiation in combination with erlotinib-results from a phase 2 randomized trial. Front Oncol. 2024 Aug 1;14:1412716. doi: 10.3389/fonc.2024.1412716. eCollection 2024.
PubMed 39148905Abravan A, Eide HA, Londalen AM, Helland A, Malinen E. Mapping Bone Marrow Response in the Vertebral Column by Positron Emission Tomography Following Radiotherapy and Erlotinib Therapy of Lung Cancer. Mol Imaging Biol. 2019 Apr;21(2):391-398. doi: 10.1007/s11307-018-1226-7.
PubMed 29916117
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Concomitant Radiotherapy and Erlotinib in Advanced Lung Cancer
- ClinicalTrials.gov ID
- NCT02714530
- Acronym / sponsor ID
- ThoRaT / ThoRaT
- Conditions
- Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Slow accrual
- Enrolment
- 118 participants (actual)
- Lead sponsor
- Oslo University HospitalUniversity, hospital or other
- Study start
- 1 Apr 2014 (actual)
- Primary completion
- 30 Dec 2020 (actual)
- Study completion
- 30 Dec 2020 (actual)
- First posted
- 21 Mar 2016 (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.
The purpose of this study is to determine if erlotinib given orally along with concurrent palliative irradiation to lung cancer improves local control compared to those treated with radiotherapy alone.
Detailed description
Endpoints:
Primary:
- To determine if erlotinib given orally along with concurrent external beam radiation therapy, prolongs local tumour control as determined by CT evaluation compared to treatment with external beam radiation therapy alone
Secondary:
- To confirm the safety profile of erlotinib along with concurrent external beam radiation therapy.
- To evaluate if erlotinib along with concurrent external beam radiation therapy, improve quality of life as assessed with the EORTC QLQ-C30 and the EORTC QLQ-LC13.
- To evaluate if PET-CT examination can be used to predict response to treatment.
- To evaluate overall survival in the different groups
Trial Design: Open multicenter two-armed randomized phase II trial.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Radiotherapy combined with erlotinib | Experimental | Drug: Erlotinib, Radiation: RadiationStandard treatment 3 Gy x 10 to lung tumor and mediastinal lymph nodes and erlotinib given concomitantly, 150 mg p.o. daily from the day before radiation, until the last day of radiation. |
| Radiotherapy alone | Active comparator | Radiation: RadiationRadiotherapy 3 Gy x 10 alone |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Age >18 years
- Histological or cytological verified NSCLC
- Palliative radiotherapy to thorax indicated
- ECOG Performance status 0-2
- Fertile patients must use contraception
Key exclusion criteria (7 listed)
- Pregnancy or nursing
- Other prior or concurrent malignant disease likely to interfere with study treatment or comparisons
- No evidence of other significant laboratory finding or concurrent uncontrolled medical illness, that in the opinion of the investigator, would interfere with study treatment or results comparison or render the patient at high risk for treatment complications
- No prior radiotherapy to the same organ / place
- No concurrent treatment with other experimental drugs
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: TarcevaTarceva daily during radiotherapy course | Drug | Radiotherapy combined with erlotinib |
| RadiationRadiotherapy | Radiation | Radiotherapy alone, Radiotherapy combined with erlotinib |
Primary outcome
Number of patients with progression in radiation field among patients treated with erlotinib combined with radiotherapy compared to radiotherapy alone
Time frame: 1 year
Evaluate local control by radiological evaluation
2 secondary outcomes
Number of Participants With Treatment-Related Adverse Events grade >3 as Assessed by CTCAE v4.0
Time frame: 1 year
Overall survival will be measured
Time frame: 1 year
Results and safety
The study was stopped early (reason given: Slow accrual). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2021.
- Derived from this study: PubMed 39148905Nymoen HM, Alver TN, Horndalsveen H, Eide HA, Bjaanaes MM, Brustugun OT, Gronberg BH, Haakensen VD, Helland A. Thoracic radiation in combination with erlotinib-results from a phase 2 randomized trial. Front Oncol. 2024 Aug 1;14:1412716. doi: 10.3389/fonc.2024.1412716. eCollection 2024.
- Derived from this study: PubMed 29916117Abravan A, Eide HA, Londalen AM, Helland A, Malinen E. Mapping Bone Marrow Response in the Vertebral Column by Positron Emission Tomography Following Radiotherapy and Erlotinib Therapy of Lung Cancer. Mol Imaging Biol. 2019 Apr;21(2):391-398. doi: 10.1007/s11307-018-1226-7.
- Individual participant dataSharing planned: Yes. Publish results
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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.
Åslaug Helland, MD PhD principal investigator
Oslo University Hospital
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 and Radiation in people with Cancer, run by Oslo University Hospital at 2 sites in Norway.
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 11 inclusion and 7 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 30 Mar 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 Norway. 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: Slow accrual). 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?
Number of patients with progression in radiation field among patients treated with erlotinib combined with radiotherapy compared to radiotherapy alone (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02714530, which also lists 2 linked publications.
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 30 Mar 2021.