NCT02714530

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
118

participants targeted

Target at P75+ for phase_2 cancer

Timeline
Completed

Started Apr 2014

Longer than P75 for phase_2 cancer

Geographic Reach
1 country

2 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2014

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

September 10, 2015

Completed
6 months until next milestone

First Posted

Study publicly available on registry

March 21, 2016

Completed
4.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2020

Completed
Last Updated

March 30, 2021

Status Verified

March 1, 2021

Enrollment Period

6.8 years

First QC Date

September 10, 2015

Last Update Submit

March 25, 2021

Conditions

Cancer

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • Number of Participants With Treatment-Related Adverse Events grade >3 as Assessed by CTCAE v4.0

    1 year

  • Overall survival will be measured

    1 year

Study Arms (2)

Radiotherapy combined with erlotinib

EXPERIMENTAL

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: ErlotinibRadiation: Radiation

Radiotherapy alone

ACTIVE COMPARATOR

Radiotherapy 3 Gy x 10 alone

Radiation: Radiation

Interventions

ErlotinibDRUG

Tarceva daily during radiotherapy course

Also known as: Tarceva
Radiotherapy combined with erlotinib
RadiationRADIATION

Radiotherapy

Radiotherapy aloneRadiotherapy combined with erlotinib

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Oslo University Hospital

Oslo, International/Other, 0310, Norway

Location

St Olavs Hospital

Trondheim, 7010, Norway

Location

Related Publications (2)

  • Nymoen HM, Alver TN, Horndalsveen H, Eide HA, Bjaanaes MM, Brustugun OT, Gronberg BH, Haakensen VD, Helland A. Thoracic radiation in combination with erlotinib-results from a phase 2 randomized trial. Front Oncol. 2024 Aug 1;14:1412716. doi: 10.3389/fonc.2024.1412716. eCollection 2024.

    PMID: 39148905DERIVED

  • 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.

    PMID: 29916117DERIVED

MeSH Terms

Conditions

Neoplasms

Interventions

Erlotinib HydrochlorideRadiation

Intervention Hierarchy (Ancestors)

QuinazolinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsPhysical Phenomena

Study Officials

  • Åslaug Helland, MD PhD

    Oslo University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD PhD

Study Record Dates

First Submitted

September 10, 2015

First Posted

March 21, 2016

Study Start

April 1, 2014

Primary Completion

December 30, 2020

Study Completion

December 30, 2020

Last Updated

March 30, 2021

Record last verified: 2021-03

Data Sharing

IPD Sharing
Will share

Publish results

Locations

NO(2)