Tarceva And Radiotherapy in Locally Advanced Lung Cancer... | NCT00888511

Studies
Tarceva And Radiotherapy in Locally Advanced Lung Cancer Non-small Cell Lung Cancer

NCT00888511

Sponsor

Olfred Hansen

Status

Completed

Last Update Posted

Nov 27, 2020Actual

Enrollment

15Actual

Phase

Phase 2

Conditions

Non-small Cell Lung Cancer

Interventions

Tarceva
Radiotherapy

Countries

Denmark

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

Participant Flow Module

Pre-assignment Details

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2020

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2009

Primary Completion Date

May 2016Actual

Completion Date

May 2016Actual

First Submitted Date

Apr 24, 2009

First Submission Date that Met QC Criteria

Apr 24, 2009

First Posted Date

Apr 27, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Apr 6, 2017

Results First Submitted that Met QC Criteria

Nov 4, 2020

Results First Posted Date

Nov 27, 2020Actual

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 4, 2020

Last Update Posted Date

Nov 27, 2020Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Olfred Hansen, MD, Odense University HospitalSponsor-Investigator

Lead Sponsor

Olfred HansenOTHER

Collaborators

Name	Class
Odense University Hospital	OTHER
Copenhagen University Hospital at Herlev	OTHER
Rigshospitalet, Denmark	OTHER
Aalborg University Hospital

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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).

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

15Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Experimental		Drug: Tarceva Radiation: Radiotherapy

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Tarceva	Drug	Tarceva 150 mg/day	1
Radiotherapy

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Progression Free Survival	Progression free survival from registration according to RECIST 1.1	3 years

Secondary Outcomes

Measure	Description	Time Frame
Toxicity		3 years
Local Tumor Control by CT-scan		May 2012
Overall Response Rate (CR + PR)

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

90 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Olfred Hansen, MD	Odense University Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of Oncology, Aarhus University Hospital		Aarhus		8000	Denmark
Department of Oncology, Rigshospitalet

ID	Title	Description
FG000	Concurrent Tarceva and RT in LA-NSCLC	Tarceva: Tarceva 150 mg/day Radiotherapy: 66 Gy/33 F/5 F per week for 5 weeks

Baseline Characteristics Module

Baseline Analysis Population Description

Not provided

Type of Units Analyzed

Not provided

Arm/Group Information

ID	Title	Description
BG000	Concurrent Tarceva and RT in LA-NSCLC	Tarceva: Tarceva 150 mg/day Radiotherapy: 66 Gy/33 F/5 F per week for 5 weeks

Denominators

Units	Counts
Participants	BG000

Baseline Measures

Title	Description	Population Description	Parameter Type	Dispersion Type	Unit of Measure	Calculate Percentage	Denominator Units Selected	Denominators	Classes
Age, Continuous			Median

Outcome Measures Module

Outcome Measures

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Progression Free Survival

Progression free survival from registration according to RECIST 1.1

Posted

Median

Full Range

months

3 years

ID	Title	Description
OG000	Concurrent Tarceva and RT in LA-NSCLC	Tarceva: Tarceva 150 mg/day Radiotherapy: 66 Gy/33 F/5 F per week for 5 weeks

Units	Counts
Participants	OG000

Adverse Events Module

Frequency Threshold

Time Frame

Not provided

Description

Not provided

All-Cause Mortality Comment

Not provided

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Concurrent Tarceva and RT in LA-NSCLC	Tarceva: Tarceva 150 mg/day Radiotherapy: 66 Gy/33 F/5 F per week for 5 weeks

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Notes	Statistical Information
Pneumonitis	Respiratory, thoracic and mediastinal disorders		Non-systematic Assessment

Other Adverse Events

Not provided

More Info Module

Limitations and Caveats

Not provided

Certain Agreements

Are all PI(s) employees of the sponsor?

Restriction Type

Point of Contact

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

Condition Browse Module

MeSH Terms

ID	Term
D002289	Carcinoma, Non-Small-Cell Lung
D008175	Lung Neoplasms

Ancestor Terms

ID	Term
D002283	Carcinoma, Bronchogenic
D001984	Bronchial Neoplasms
D012142	Respiratory Tract Neoplasms
D013899	Thoracic Neoplasms

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000069347	Erlotinib Hydrochloride
D011878	Radiotherapy

Ancestor Terms

ID	Term
D011799	Quinazolines
D006574	Heterocyclic Compounds, 2-Ring
D000072471	Heterocyclic Compounds, Fused-Ring
D006571	Heterocyclic Compounds

Browse Leaves

Not provided

Browse Branches

Not provided