A Study of Erlotinib Plus Radiotherapy (RT) for Patients With Advanced or Inoperable Non-Small-Cell Lung Cancer
|ClinicalTrials.gov Identifier: NCT00983307|
Recruitment Status : Completed
First Posted : September 24, 2009
Results First Posted : January 30, 2018
Last Update Posted : January 30, 2018
It is generally accepted that the presence of chronically hypoxic cells, or tumor cells which do not receive enough oxygen as a result of tumor growth, may be an important cause of resistance to radiation therapy (RT) and resultant tumor recurrence, particularly in large tumors such as advanced non-small-cell lung cancer (NSCLC). Therefore, delivering a higher RT dose, as is done with hypofractionated RT, to the tumor may result in higher success rate.
Erlotinib (Tarceva, previously known as OSI-774) is an orally active, potent, selective inhibitor of the Epidermal Growth Factor Receptor (EGFR) tyrosine kinase. A recently completed trial has shown that Erlotinib as a single agent significantly improves the survival of patients with incurable Stage IIIb/IV NSCLC who have failed standard therapy for advanced or metastatic disease. Therefore, Erlotinib is an approved medication for second-line therapy in lung cancer following prior chemotherapy.
This is a Phase II clinical research study to assess the efficacy and toxicity of hypofractionated radiation therapy in combination with Erlotinib in patients with locally advanced or inoperable non-small-cell lung cancer (NSCLC).
The investigators' hypothesis is that the addition of erlotinib to RT will result in radiosensitization, therefore increasing the likelihood of local tumor control over RT alone. Maintenance erlotinib upon RT completion will result in further tumor growth inhibition, both systemically and locally, lengthening disease-free survival and overall survival.
|Condition or disease||Intervention/treatment||Phase|
|Carcinoma, Non-small-cell Lung||Drug: Erlotinib Radiation: Hypofractionated Radiotherapy||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||17 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Study of Erlotinib (Tarceva) and Hypofractionated Thoracic Radiotherapy for Patients With Advanced or Inoperable Non-Small-Cell Lung Cancer|
|Actual Study Start Date :||August 27, 2009|
|Actual Primary Completion Date :||December 2012|
|Actual Study Completion Date :||December 2012|
Experimental: Erlotinib and radiotherapy
Patients will be treated with Erlotinib and hypofractionated radiotherapy.
Patients will receive Tarceva, 150 mg daily on days -5 through -1 days and will start a course of hypofractionated thoracic RT on Day 1. RT will be administered daily on weekdays (Monday-Friday) and not on weekends or holidays. Tarceva administration will be continued daily during RT (also on weekends/holidays when RT is not given) and after RT will be continued daily as maintenance therapy until death or disease progression.
Radiation: Hypofractionated Radiotherapy
Patients undergo hypofractionated thoracic RT 5 days a week for approximately 2.5 weeks beginning on day 0. Patients also receive erlotinib hydrochloride PO daily beginning on day -5 and continuing for up to 24 months in the absence of disease progression or unacceptable toxicity.
- Number of Participants That Experience Progression-free Survival. [ Time Frame: 2 years ]Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00983307
|United States, Pennsylvania|
|Northeast Radiation Oncology Center|
|Dunmore, Pennsylvania, United States, 18512|
|Thomas Jefferson Univeristy|
|Philadelphia, Pennsylvania, United States, 19107|
|Principal Investigator:||Maria Werner-Wasik, MD||Thomas Jefferson University|