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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
Sponsor:
Information provided by (Responsible Party):
Åslaug Helland, Oslo University Hospital

Tracking Information
First Submitted Date  ICMJE September 10, 2015
First Posted Date  ICMJE March 21, 2016
Last Update Posted Date March 30, 2021
Actual Study Start Date  ICMJE April 1, 2014
Actual Primary Completion Date December 30, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 15, 2016)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 15, 2016)
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Thoracal Radiotherapy and Tarceva
Official Title  ICMJE Concomitant Radiotherapy and Erlotinib in Advanced Lung Cancer
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.
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  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Cancer
Intervention  ICMJE
  • Drug: Erlotinib
    Tarceva daily during radiotherapy course
    Other Name: Tarceva
  • Radiation: Radiation
    Radiotherapy
Study Arms  ICMJE
  • 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.
    Interventions:
    • Drug: Erlotinib
    • Radiation: Radiation
  • Active Comparator: Radiotherapy alone
    Radiotherapy 3 Gy x 10 alone
    Intervention: Radiation: Radiation
Publications * Abravan A, Eide HA, Løndalen AM, Helland Å, 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: March 25, 2021)
118
Original Estimated Enrollment  ICMJE
 (submitted: March 15, 2016)
150
Actual Study Completion Date  ICMJE December 30, 2020
Actual Primary Completion Date December 30, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Norway
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02714530
Other Study ID Numbers  ICMJE ThoRaT
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: Publish results
Responsible Party Åslaug Helland, Oslo University Hospital
Study Sponsor  ICMJE Oslo University Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Åslaug Helland, MD PhD Oslo University Hospital
PRS Account Oslo University Hospital
Verification Date March 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP