Phase I Study of Iressa and CRT/IMRT in Chinese Patients With IIIB/IV NSCLC After Failure of Platinum-Based Chemotherapy
Laboratory research has suggested that targeting specific signalling proteins would be well
suited for selectively enhancing the tumor radiosensitivity. In human xenograft models
(non-small cell lung cancer and breast cancer) treated with gefitinib and irradiation,
combined therapy has shown a significant increase in tumor growth delay as compared with
monotherapy of irradiation or gefitinib. The epidermal growth factor receptor tyrosine
kinase inhibitor ZD1839 selectively potentiates radiation response of human tumors in nude
mice, with a marked improvement in therapeutic index. The authors concluded that gefitinib
profoundly enhanced the antitumor action of RT against the tested tumors without significant
adverse effects, increasing the therapeutic selectively of ionizing radiation in certain
model systems. Substantial benefits for this multimodality therapy in patients could be
expected.
While there are no published data on the feasibility and efficacy of combined gefitinib and
radiation therapy in Chinese population who might be susceptible to gefitinib monotherapy,
clinical studies have demonstrated that combining gefitinib with external beam radiation to
66-74Gy and concurrent weekly chemotherapy after induction chemotherapy were tolerated
without excessive toxicity. In the present trail, we hope to build on our own experience of
using combined gefitinib and thoracic radiation with 3D-CRT or intensity-modulated
radiotherapy (IMRT) technique in a phase I setting for stage IIIb and selected stage IV
NSCLC. We will follow this treatment (RT and gefitinib) with 60 days gefitinib at standard
systemic doses.
Interventional
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Dose-limiting toxicities per protocol
3, 6 and 12 months
Yes
Guoliang Jiang, MD
Principal Investigator
Fudan University Cancer Hospital, Department of Radiation Oncology
China: Ethics Committee
FDCA001
NCT00497250
July 2007
October 2009
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