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

Non-small Cell Lung Cancer Clinical Trial

— TARLAL  

Official title:

Concomitant Tarceva® and Irradiation in Patients in Local-regionally Advanced Non-small Cell Lung Cancer. A Phase II Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00888511
• Other study ID #: 09.02
• Status: Completed
• Phase: Phase 2
• Start date: May 2009
• Est. completion date: May 2016

Study information

• Verified date: November 2020
• Source: Odense University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: May 2016
• Est. primary completion date: May 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Non-small Cell Lung Cancer

Intervention

Drug:
• Tarceva
Tarceva 150 mg/day

Radiation:
• Radiotherapy
66 Gy/33 F/5 F per week for 5 weeks

Locations

Country	Name	City	State
Denmark	Department of Oncology, Aarhus University Hospital	Aarhus
Denmark	Department of Oncology, Rigshospitalet	Copenhagen
Denmark	Department of Oncology, Copenhagen University Hospital at Herlev	Herlev
Denmark	Department of Oncology, Naestved Hospital	Naestved
Denmark	Laboratory of Radiation Physics	Odense
Denmark	Odense University Hospital	Odense
Denmark	Department of Oncology, Vejle Hospital	Vejle

Sponsors (7)

Lead Sponsor	Collaborator
Olfred Hansen	Aalborg University Hospital, Aarhus University Hospital, Copenhagen University Hospital at Herlev, Naestved Hospital, Odense University Hospital, Rigshospitalet, Denmark

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression Free Survival	Progression free survival from registration according to RECIST 1.1	3 years
Secondary	Toxicity		3 years
Secondary	Local Tumor Control by CT-scan		May 2012
Secondary	Overall Response Rate (CR + PR)		May 2012
Secondary	Local Tumor Control at 9 Months Evaluated by PET-CT		May 2012
Secondary	Overall Survival		May 2012
Secondary	Disease Free Survival		May 2012
Secondary	Late Toxicity		May 2012