ThoRaT: Thoracal Radiotherapy and Tarceva

Sponsor

Oslo University Hospital (Other)

Overall Status

Terminated

CT.gov ID

NCT02714530

Collaborator

(none)

118

Enrollment

Locations

Arms

Actual Duration (Months)

Patients Per Site

0.7

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Cancer	Drug: Erlotinib Radiation: Radiation	Phase 2

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 Design

Study Type:

Interventional

Actual Enrollment :

118 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Concomitant Radiotherapy and Erlotinib in Advanced Lung Cancer

Actual Study Start Date :

Apr 1, 2014

Actual Primary Completion Date :

Dec 30, 2020

Actual Study Completion Date :

Dec 30, 2020

Arms and Interventions

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.	Drug: Erlotinib Tarceva daily during radiotherapy course Other Names: Tarceva Radiation: Radiation Radiotherapy
Active Comparator: Radiotherapy alone Radiotherapy 3 Gy x 10 alone	Radiation: Radiation Radiotherapy

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.

Drug: Erlotinib

Tarceva daily during radiotherapy course

Other Names:

Tarceva

Radiation: Radiation

Radiotherapy

Active Comparator: Radiotherapy alone

Radiotherapy 3 Gy x 10 alone

Radiation: Radiation

Radiotherapy

Outcome Measures

Primary Outcome Measures

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

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.
Overall survival will be measured [1 year]
To evaluate overall survival in the different groups

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Oslo University Hospital	Oslo	International/Other	Norway	0310
2	St Olavs Hospital	Trondheim		Norway	7010

Sponsors and Collaborators

Oslo University Hospital

Investigators

Principal Investigator: Åslaug Helland, MD PhD, Oslo University Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Åslaug Helland, MD PhD, Oslo University Hospital

ClinicalTrials.gov Identifier:

NCT02714530

Other Study ID Numbers:

ThoRaT

First Posted:

Mar 21, 2016

Last Update Posted:

Mar 30, 2021

Last Verified:

Mar 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

Additional relevant MeSH terms:

Erlotinib Hydrochloride

Study Results

No Results Posted as of Mar 30, 2021