A Phase I Dose Escalation Trial of Preoperative Chemoradiotherapy Utilizing Intensity Modulated Radiation Therapy(IMRT)in Combination With Bevacizumab-FOLFOX for Patients With Locally Advanced Rectal Cancer
Rectal cancer has been one of the leading cancers in Taiwan and other countries in the
world. Preoperative neoadjuvant concurrent chemoradiotherapy (CCRT) is the well accepted and
widely used modality for locally advanced rectal cancer, to improve the local control,
reduce the treatment related toxicity, and to increase the anal preservation rate. Intensity
modulated radiation therapy (IMRT), the most common advanced technique in recent 10 years,
has been proven effective in dose escalation, treatment target conformity, and normal tissue
sparing. The ongoing trials on rectal cancer increasingly adopt IMRT as the treatment
technique. Bevacizumab (BV), the developed drug targeting on vascular endothelial growth
factor, has been proven for its effective use in metastatic colorectal cancer. Besides, BV
has showed its good radiosensitizing effects in the evolving neoadjuvant CCRT trials using
traditional big-field pelvis radiotherapy on rectal cancer, the ongoing brain tumor trials,
and the basic researches. Neoadjuvant CCRT using the combination of IMRT and BV may have the
dual advantages of reduced treatment toxicity by technique and increased pathological
response by radiosensitization for the possible improved outcomes. In this phase I trial
neoadjuvant CCRT with combined IMRT with three escalated dose levels (45 Gy, 50 Gy, and 55
Gy in 25 fractions) and BV-fluorouracil/ leucovorin/oxaliplatin (FOLFOX) regimens is planned
for 15 locally advanced rectal cancer patients. The primary goal is to define the maximally
tolerated dose of radiotherapy and the treatment related acute toxicity, and demonstrate
that preoperative highly conformal IMRT and concurrent BV-chemotherapy will lead to
acceptable acute gastrointestinal morbidity. The secondary goal is to demonstrate that this
treatment modality will elicit a comparable or improved rate of T stage downstaging and
complete response pathologically.
Interventional
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Maximally tolerated dose
To define the maximally tolerated dose of radiotherapy and the treatment related acute toxicity and to demonstrate that preoperative highly conformal radiotherapy and concurrent bevacizumab-chemotherapy will lead to acceptable acute gastrointestinal morbidity
5 years
Yes
Jason CH Cheng, M.D. Ph.D.
Principal Investigator
National Taiwan University Hospital
Taiwan: Department of Health
201103126MB
NCT01395667
June 2011
May 2013
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