Intensity Modulated Radiation Therapy With Cisplatin and Gemcitabine to Treat Locally Advanced Cervical Carcinoma
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|ClinicalTrials.gov Identifier: NCT01554410|
Recruitment Status : Active, not recruiting
First Posted : March 15, 2012
Last Update Posted : November 5, 2020
|Condition or disease||Intervention/treatment||Phase|
|Cervical Carcinoma||Radiation: Intensity Modulated Radiation Therapy (IMRT) Drug: Cisplatin Drug: Gemcitabine||Phase 1|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||19 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase I Trial of Intensity Modulated Radiation Therapy With Concurrent Cisplatin and Escalating Gemcitabine for Locally Advanced Cervical Carcinoma|
|Study Start Date :||August 2010|
|Estimated Primary Completion Date :||January 2021|
|Estimated Study Completion Date :||January 2021|
All patients get IMRT with concurrent cisplatin & gemcitabine, with the dose of gemcitabine varying according to cohort
Radiation: Intensity Modulated Radiation Therapy (IMRT)
45 Gy in 25 daily fractions (1.8 Gy per fraction)
Weekly infusion of 40 mg/m2 x 5 weeks (70 mg maximum)
Weekly infusion x 5 weeks at escalating dose levels (50mg/m2, 75mg/m2, 100mg/m2, and 125mg/m2)
- Establish the maximum tolerated dose (MTD) of Gemcitabine that can be safely administered in combination with Cisplatin [ Time Frame: 5 weeks during treatment ]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
- Number of Participants with Acute Adverse Events as a Measure of Safety and Tolerability [ Time Frame: Up to 30 Days post-treatment ]To quantify acute treatment-related adverse events that occur within 30 days of completing protocol treatment.
- Number of Participants with Progression-Free Survival as a Measure of Response [ Time Frame: Up to 12 months post treatment ]To determine the progression-free and overall survival of patients treated with gemcitabine at the MTD in this regimen.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01554410
|United States, California|
|Moores UC San Diego Cancer Center|
|La Jolla, California, United States, 92093|
|Principal Investigator:||Loren Mell, MD||University of California, San Diego|