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A Phase II Study on the Safety and Efficacy of Radiation Therapy and Concurrent Erlotinib in Locally Advanced Non-small-cell Lung Cancer


Phase 2
18 Years
70 Years
Open (Enrolling)
Both
Carcinoma, Non-Small Cell Lung

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Trial Information

A Phase II Study on the Safety and Efficacy of Radiation Therapy and Concurrent Erlotinib in Locally Advanced Non-small-cell Lung Cancer


Non-small cell lung cancer (NSCLC) is still the leading cause of cancer death world-wide.
Radiation therapy (RT) is one of the most important treatment choices in locally advanced
NSCLC. Combination of RT and chemotherapy could improve treatment outcomes. However, the
combined modality could not be used in many patients due to severe toxicities. EGFR-TKI
shows great efficacy in the treatment of NSCLC, and many phase I/II studies established its
safety in combination with RT. This phase II study is to further evaluate the efficacy and
safety of the combination of RT and erlotinib in the treatment of locally advanced NSCLC.
Eligible patients include patients with stage IIIA/IIIB NSCLC, who are not suitable for or
refused to receive concurrent chemoradiotherapy. Eligible patients will receive oral
erlotinib (150mg qd)throughout the course of thoracic RT (60-70 Gy). The primary endpoint is
progression free survival and the second endpoints are overall survival and any grade III
and above toxicities. We are going to recruit 50 patients for this study.


Inclusion Criteria:



- Aged 18-70 years，

- Patients with stage IIIA-IIIB NSCLC

- adequate hematologic (WBC and platelet counts within normal limits), hepatic (total
bilirubin level <= two times the upper limit of normal), and renal (creatinine
clearance >= 50mL/min) functions

- No history of chemotherapy or less than 4 cycles neoadjuvant chemotherapy

- Can not tolerate or refuse concurrent chemoradiotherapy

- No history of thoracic RT

- Written informed consent obtained

Exclusion Criteria:

- With other malignancy

- With severe cardiopulmonary disease

- Compromised liver or renal function that could not tolerate the combined therapy

- Received thoracic RT before

- Pregnant or breast-feeding women

- Present with active infection

- Uncontrolled diabetes

- Concurrent use of other anti-cancer agents

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Evidence of clinically definite disease progression

Outcome Time Frame:

3 year

Safety Issue:

No

Principal Investigator

Zhiyong Yuan, M.D., Ph.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Tianjin Medical University Cancer Institute and Hospital

Authority:

China: Ethics Committee

Study ID:

TMU-CIH-L001

NCT ID:

NCT00973310

Start Date:

October 2009

Completion Date:

October 2015

Related Keywords:

  • Carcinoma, Non-Small Cell Lung
  • Non-small-cell lung cancer
  • Radiation therapy
  • Epidermal growth factor receptor
  • Tyrosine kinase inhibitor
  • Carcinoma
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms

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