NCT00888511

Brief Summary

The trial is a phase II study of daily Tarceva combined with definitive radiotherapy in inoperable locally advanced non small cell lung cancer (stage IIB-IIIB). The objective of the phase II trial is to examine Tarceva concomitant with curatively intended irradiation 66 Gy (2 Gy x 33 F, 5 F per week).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
15

participants targeted

Target at below P25 for phase_2 nonsmall-cell-lung-cancer

Timeline
Completed

Started May 2009

Longer than P75 for phase_2 nonsmall-cell-lung-cancer

Geographic Reach
1 country

7 active sites

Status
completed

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

First Submitted

Initial submission to the registry

April 24, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 27, 2009

Completed
4 days until next milestone

Study Start

First participant enrolled

May 1, 2009

Completed
7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2016

Completed
4.6 years until next milestone

Results Posted

Study results publicly available

November 27, 2020

Completed
Last Updated

November 27, 2020

Status Verified

November 1, 2020

Enrollment Period

7 years

First QC Date

April 24, 2009

Results QC Date

April 6, 2017

Last Update Submit

November 4, 2020

Conditions

Non-small Cell Lung Cancer

Keywords

Lung cancerNon-small cell lung cancerTarcevaRadiotherapyLocal-regionally advanced non-small cell lung cancer

Outcome Measures

Primary Outcomes (1)

  • Progression Free Survival

    Progression free survival from registration according to RECIST 1.1

    3 years

Secondary Outcomes (7)

  • Toxicity

    3 years

  • Local Tumor Control by CT-scan

    May 2012

  • Overall Response Rate (CR + PR)

    May 2012

  • Local Tumor Control at 9 Months Evaluated by PET-CT

    May 2012

  • Overall Survival

    May 2012

  • +2 more secondary outcomes

Study Arms (1)

1

EXPERIMENTAL
Drug: TarcevaRadiation: Radiotherapy

Interventions

TarcevaDRUG

Tarceva 150 mg/day

1
RadiotherapyRADIATION

66 Gy/33 F/5 F per week for 5 weeks

1

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age ≥18 years
  • Patients with histologically or cytologically documented diagnosis locally advanced NSCLC stage IIB to IIIB without pleural effusion
  • Performance status ≤2 on the ECOG scale
  • Serum bilirubin must be ≤1.5 upper limit of normal (ULN)
  • ALAT ≤2 x ULN
  • Able to comply with study and follow-up procedures
  • Patients with reproductive potential must use effective contraception
  • Written (signed) informed consent to participate in the study

You may not qualify if:

  • Any unstable systemic disease (including active infection, unstable angina, congestive heart failure, severe hepatic, renal, or metabolic disease)
  • Any other malignancies within 5 years (except for adequately treated carcinoma in situ of the cervix or basal or squamous cell skin cancer)
  • Inability to take oral medication, or requirement of intravenous alimentation
  • Nursing mothers

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

Department of Oncology, Aarhus University Hospital

Aarhus, 8000, Denmark

Location

Department of Oncology, Rigshospitalet

Copenhagen, 2100, Denmark

Location

Department of Oncology, Copenhagen University Hospital at Herlev

Herlev, 270, Denmark

Location

Department of Oncology, Naestved Hospital

Næstved, Denmark

Location

Laboratory of Radiation Physics

Odense, 5000, Denmark

Location

Odense University Hospital

Odense, 5000, Denmark

Location

Department of Oncology, Vejle Hospital

Vejle, 7100, Denmark

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell LungLung Neoplasms

Interventions

Erlotinib HydrochlorideRadiotherapy

Condition Hierarchy (Ancestors)

Carcinoma, BronchogenicBronchial NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

QuinazolinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsTherapeutics

Results Point of Contact

Title
Olfred Hansen
Organization
Odense University Hospital
olfred.hansen@rsyd.dk
+45 2424 1588

Study Officials

  • Olfred Hansen, MD

    Odense University Hospital

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

April 24, 2009

First Posted

April 27, 2009

Study Start

May 1, 2009

Primary Completion

May 1, 2016

Study Completion

May 1, 2016

Last Updated

November 27, 2020

Results First Posted

November 27, 2020

Record last verified: 2020-11

Locations

DK(7)