- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02714530
Thoracal Radiotherapy and Tarceva (ThoRaT)
March 25, 2021 updated by: Åslaug Helland, Oslo University Hospital
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.
Study Overview
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 Type
Interventional
Enrollment (Actual)
118
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Trondheim, Norway, 7010
- St Olavs Hospital
-
-
International/Other
-
Oslo, International/Other, Norway, 0310
- Oslo University Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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
- 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
Exclusion Criteria:
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Radiotherapy combined with erlotinib
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.
|
Radiotherapy
Tarceva daily during radiotherapy course
Other Names:
|
Active Comparator: Radiotherapy alone
Radiotherapy 3 Gy x 10 alone
|
Radiotherapy
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
1 year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Participants With Treatment-Related Adverse Events grade >3 as Assessed by CTCAE v4.0
Time Frame: 1 year
|
To confirm the safety profile of erlotinib along with concurrent external beam radiation therapy.
|
1 year
|
Overall survival will be measured
Time Frame: 1 year
|
To evaluate overall survival in the different groups
|
1 year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Åslaug Helland, MD PhD, Oslo University Hospital
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
April 1, 2014
Primary Completion (Actual)
December 30, 2020
Study Completion (Actual)
December 30, 2020
Study Registration Dates
First Submitted
September 10, 2015
First Submitted That Met QC Criteria
March 15, 2016
First Posted (Estimate)
March 21, 2016
Study Record Updates
Last Update Posted (Actual)
March 30, 2021
Last Update Submitted That Met QC Criteria
March 25, 2021
Last Verified
March 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- ThoRaT
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
Publish results
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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