Thoracal Radiotherapy and Tarceva (ThoRaT)
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|ClinicalTrials.gov Identifier: NCT02714530|
Recruitment Status : Terminated (Slow accrual)
First Posted : March 21, 2016
Last Update Posted : March 30, 2021
|Condition or disease||Intervention/treatment||Phase|
|Cancer||Drug: Erlotinib Radiation: Radiation||Phase 2|
- 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
- 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 (Clinical Trial)|
|Actual Enrollment :||118 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Concomitant Radiotherapy and Erlotinib in Advanced Lung Cancer|
|Actual Study Start Date :||April 1, 2014|
|Actual Primary Completion Date :||December 30, 2020|
|Actual Study Completion Date :||December 30, 2020|
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.
Tarceva daily during radiotherapy course
Other Name: Tarceva
Active Comparator: Radiotherapy alone
Radiotherapy 3 Gy x 10 alone
- 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
- 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.
- Overall survival will be measured [ Time Frame: 1 year ]To evaluate overall survival in the different groups
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02714530
|Oslo University Hospital|
|Oslo, International/Other, Norway, 0310|
|St Olavs Hospital|
|Trondheim, Norway, 7010|
|Principal Investigator:||Åslaug Helland, MD PhD||Oslo University Hospital|