A Study of Erlotinib Plus Radiotherapy (RT) for Patients With Advanced or Inoperable Non-Small-Cell Lung Cancer
Public ClinicalTrials.gov record NCT00983307. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Phase II Study of Erlotinib (Tarceva) and Hypofractionated Thoracic Radiotherapy for Patients With Advanced or Inoperable Non-Small-Cell Lung Cancer
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT00983307
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 17 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Aug 26, 2009
- Primary completion
- Nov 30, 2012
- Completion
- Nov 30, 2012
- Last update posted
- Apr 29, 2025
2009 – 2012
United States locations
- U.S. sites
- 2
- U.S. states
- 1
- U.S. cities
- 2
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Northeast Radiation Oncology Center | Dunmore | Pennsylvania | 18512 | — |
| Thomas Jefferson Univeristy | Philadelphia | Pennsylvania | 19107 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT00983307, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Apr 29, 2025 · Synced Sep 11, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT00983307 live on ClinicalTrials.gov.