Thoracal Radiotherapy and Tarceva (ThoRaT)

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

• Status: Terminated
• Conditions: Cancer
• Intervention / Treatment: Radiation: Radiation; Drug: Erlotinib

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

Study Locations

• Norway
  • Trondheim, Norway, 7010
    • St Olavs hospital
  • International/Other
    • Oslo, International/Other, Norway, 0310
      • Oslo University Hospital

Participation Criteria

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

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

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.	Radiation: Radiation; Radiotherapy; Drug: Erlotinib; Tarceva daily during radiotherapy course; Other Names: Tarceva
Active Comparator: Radiotherapy alone; Radiotherapy 3 Gy x 10 alone	Radiation: Radiation; 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	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	To confirm the safety profile of erlotinib along with concurrent external beam radiation therapy.	1 year
Overall survival will be measured	To evaluate overall survival in the different groups	1 year

Collaborators and Investigators

• Sponsor: Oslo University Hospital
• Investigators: Principal Investigator: Åslaug Helland, MD PhD, Oslo University Hospital

Publications and helpful links

General Publications

• Abravan 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.

Study record dates

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: Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antineoplastic Agents; Protein Kinase Inhibitors; Erlotinib Hydrochloride
• Other Study ID Numbers: ThoRaT

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Publish results