Clinical trial NCT02714530: Thoracal Radiotherapy and Tarceva
Official title: Concomitant Radiotherapy and Erlotinib in Advanced Lung Cancer
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Cancer
Lead sponsor: Oslo University Hospital
Sponsor class: OTHER
First posted: 2016-03-21
Enrollment: 118
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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.

Primary outcomes:
measure: Number of patients with progression in radiation field among patients treated with erlotinib combined with radiotherapy compared to radiotherapy alone
timeFrame: 1 year
Secondary outcomes:
measure: Number of Participants With Treatment-Related Adverse Events grade >3 as Assessed by CTCAE v4.0
timeFrame: 1 year
measure: Overall survival will be measured
timeFrame: 1 year
Other outcomes:
Locations:
city: Oslo
country: Norway
facility: Oslo University Hospital
state: International/Other
city: Trondheim
country: Norway
facility: St Olavs Hospital
Study officials:
affiliation: Oslo University Hospital
name: Åslaug Helland, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.