A Phase I Trial of Intensity Modulated Radiation Therapy With Concurrent Cisplatin and Escalating Gemcitabine for Locally Advanced Cervical Carcinoma
Many studies have investigated multiagent chemotherapy as a means of intensifying treatment.
The results of such trials indicate that gemcitabine has considerable activity against
cervical cancer when given with cisplatin/RT, however, it is quite toxic. The predominant
toxicities are gastrointestinal and hematologic. Methods to reduce gastrointestinal and
hematologic toxicity during chemoradiotherapy could mitigate this toxicity and take
advantage of the therapeutic benefits of gemcitabine
IMRT is an advanced radiation therapy delivery technique that reduces the amount of
radiation given to normal tissues and may therefore reduce unwanted side effects. IMRT
tries to lower the amount of radiation that normal tissues receive, while still delivering
the desired amount of radiation to the cancer cells and other areas, such as lymph nodes.
IMRT does this by using computers to design the best way to aim radiation at the tumor(s),
while still delivering a radiation dose comparable to standard radiation.
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Establish the maximum tolerated dose (MTD) of Gemcitabine that can be safely administered in combination with Cisplatin
To determine the maximum tolerated dose (MTD) of weekly gemcitabine that can be administered with concurrent weekly cisplatin and pelvic intensity modulated radiation therapy (IMRT) in women with locally advanced cervical cancer
5 weeks during treatment
Loren Mell, MD
University of California, San Diego
United States: Institutional Review Board
|Moores UC San Diego Cancer Center||La Jolla, California 92093|