Thoracal Radiotherapy and Tarceva

Phase 2

Terminated

• Conditions: Cancer
• Interventions: Drug: Erlotinib; Radiation: Radiation

• Registration Number: NCT02714530
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2014-04-01
• Study First Submitted: 2015-09-10
• Study First Submitted QC: 2016-03-15
• Study First Posted: 2016-03-21
• Primary Completion: 2020-12-30
• Study Completion: 2020-12-30
• Status Verified: 2021-03
• Last Update Submitted: 2021-03-25
• Last Update Posted: 2021-03-30

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 118

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Radiotherapy combined with erlotinib	Radiation	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.
Radiotherapy alone	Radiation	Radiotherapy 3 Gy x 10 alone
Radiotherapy combined with erlotinib	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.

Primary Outcome Measures

Name	Time	Method
Number of patients with progression in radiation field among patients treated with erlotinib combined with radiotherapy compared to radiotherapy alone	1 year	Evaluate local control by radiological evaluation

Secondary Outcome Measures

Name	Time	Method
Overall survival will be measured	1 year	To evaluate overall survival in the different groups
Number of Participants With Treatment-Related Adverse Events grade >3 as Assessed by CTCAE v4.0	1 year	To confirm the safety profile of erlotinib along with concurrent external beam radiation therapy.

Trial Locations

Locations (2)

St Olavs Hospital; 🇳🇴 Trondheim, Norway

Oslo University Hospital; 🇳🇴 Oslo, International/Other, Norway