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Thoracal Radiotherapy and Tarceva (ThoRaT)

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ClinicalTrials.gov Identifier: NCT02714530
Recruitment Status : Recruiting
First Posted : March 21, 2016
Last Update Posted : August 28, 2018
Sponsor:
Information provided by (Responsible Party):
Åslaug Helland, Oslo University Hospital

Brief 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.

Condition or disease Intervention/treatment Phase
Cancer Drug: Erlotinib Radiation: Radiation Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Concomitant Radiotherapy and Erlotinib in Advanced Lung Cancer
Study Start Date : October 2014
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine


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.
Drug: Erlotinib
Tarceva daily during radiotherapy course
Other Name: Tarceva

Radiation: Radiation
Radiotherapy

Active Comparator: Radiotherapy alone
Radiotherapy 3 Gy x 10 alone
Radiation: Radiation
Radiotherapy




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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.

  2. Overall survival will be measured [ Time Frame: 1 year ]
    To evaluate overall survival in the different groups



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

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


Contacts
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Contact: Åslaug Helland, Md PhD ahelland@medisin.uio.no
Contact: Odd Brustugun, MD PhD otb@ous-hf.no

Locations
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Norway
Oslo University Hospital Recruiting
Oslo, International/Other, Norway, 0310
Contact: Åslaug Helland, MD PhD    95940863    ahelland@medisin.uio.no   
Contact: Tina Traa    +22934000    tina.traa@ous-hf.no   
St Olavs Hospital Recruiting
Trondheim, Norway, 7010
Contact: Bjørn Henning Grønberg, MD PhD       bjorn.h.gronberg@gmail.com   
Sponsors and Collaborators
Oslo University Hospital
Investigators
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Principal Investigator: Åslaug Helland, MD PhD Oslo University Hospital
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Åslaug Helland, MD PhD, Oslo University Hospital
ClinicalTrials.gov Identifier: NCT02714530    
Other Study ID Numbers: ThoRaT
First Posted: March 21, 2016    Key Record Dates
Last Update Posted: August 28, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Publish results
Additional relevant MeSH terms:
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Erlotinib Hydrochloride
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action