Preoperative Chemoradiotherapy Utilizing Intensity Modulated Radiation Therapy in Combination With Bevacizumab-FOLFOX
Condition: Rectal Cancer
MeSH terms: Rectal Neoplasms
Study type: Interventional
Phase: Phase 1

Summary: 
      In this phase I trial neoadjuvant CCRT combining 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 to 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.
    

Detailed description: 
      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.
    

Intervention name(s): CCRT
Intervention type(s): Other
Intervention description(s): Combined IMRT with three escalated dose levels (45 Gy, 50 Gy, and 55 Gy in 25 fractions) and Bevacizumab-fluorouracil/ leucovorin/oxaliplatin (FOLFOX) regimens
Other intervention name(s): IMRT; Bevacizumab; Fluorouracil; Leucovorin; Oxaliplatin
Intervention MeSH terms: Leucovorin; Fluorouracil; Oxaliplatin
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment