Phase II/III Clinical Trial of Intensity Modulated Radiation Therapy With Concurrent Cisplatin for Stage I-IVA Cervical Carcinoma
Multiple randomized controlled trials have established concurrent cisplatin-based
chemoradiotherapy as the standard of care for locally advanced cervical cancer [3-8]. The
addition of concurrent cisplatin to radiotherapy (RT) increases pelvic control, disease-free
survival (DFS) and overall survival; however, 5-year DFS and overall survival are still only
approximately 60% and 5-year pelvic failure is approximately 30%. Moreover, acute
gastrointestinal (GI) and hematologic toxicity are increased. Approximately 30% of patients
will experience acute grade ≥ 3 toxicity, predominantly GI and hematologic. Methods to
reduce toxicity during chemoradiotherapy, particularly gastrointestinal and hematologic,
could mitigate this toxicity and take advantage of the therapeutic benefits of intensive
concurrent chemotherapy.
Intensity modulated radiation therapy (IMRT) is a modern RT technique that differs from
conventional techniques in many ways. First, patients undergo computed tomography (CT)
simulation so that customized target volumes can be defined 3-dimensionally. IMRT treatment
planning involves multiple beam angles and uses computerized inverse treatment planning
optimization algorithms to identify dose distributions and intensity patterns that conform
dose to the target, reducing radiation dose to surrounding tissues. IMRT delivery is
typically accomplished with the use of multileaf collimators, which involve small motorized
leaflets (collimators) that move in and out of the beam path, modulating the dose intensity.
Interventional
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Number of Patients with Adverse Events as a Measure of Safety and Tolerability
To test whether IMRT will reduce the rate of acute grade ≥ 3 hematologic or clinically significant grade ≥ 2 gastrointestinal toxicity compared to conventional RT techniques for cervical cancer patients treated with concurrent cisplatin
Up to 10 weeks while on Treatment
Yes
Loren Mell, MD
Study Director
University of California, San Diego
United States: Institutional Review Board
INTERTECC
NCT01554397
September 2011
December 2017
Name | Location |
---|---|
Holden Comprehensive Cancer Center | Iowa City, Iowa 52242-1009 |
University Of Miami Miller School Of Medicine | Miami, Florida 33010 |
Moores UC San Diego Cancer Center | La Jolla, California 92093 |
Moffitt Cancer Center and Research Institute, H. Lee Moffitt Cancer Center | Tampa, Florida 33612 |
University of Pittsburgh Cancer Center, UPMC | Pittsburgh, Pennsylvania 15243 |