Thoracal Radiotherapy and Tarceva

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

118 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-04-01

Study Completion Date

2020-12-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Erlotinib

Intervention Type DRUG

Tarceva daily during radiotherapy course

Radiation

Intervention Type RADIATION

Radiotherapy

Radiotherapy alone

Radiotherapy 3 Gy x 10 alone

Group Type ACTIVE_COMPARATOR

Radiation

Intervention Type RADIATION

Radiotherapy

Interventions

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Erlotinib

Tarceva daily during radiotherapy course

Intervention Type DRUG

Radiation

Radiotherapy

Intervention Type RADIATION

Other Intervention Names

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Tarceva

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No