A randomized phase II study comparing preoperative mFOLFOX6 versus FOLFOXIRI for locally advanced colon cancer: JCOG2006.
Tadayoshi HashimotoSatoshi MaruyamaYasumasa TakiiJunki MizusawaTomoko KataokaHaruhiko FukudaShunsuke TsukamotoAtsuo TakashimaTetsuya HamaguchiYukihide KanemitsuPublished in: Future oncology (London, England) (2023)
The prognosis of locally advanced colon cancer (LACC) with surgical resection followed only by adjuvant chemotherapy is poor. Preoperative chemotherapy for LACC patients with risk factors such as cT4bN+ or cT3-4aN2-3 has attracted attention. Here, the authors describe the rationale and design of JCOG2006, a randomized phase II study comparing preoperative chemotherapy with mFOLFOX6 versus FOLFOXIRI for LACC. Their efficacy and safety are evaluated and a determination of which is the more promising treatment will be conducted in a subsequent phase III trial. A total of 86 patients will be accrued from 44 institutions over 2 years. The primary end point is the proportion of patients with a Tumor Regression Score of 0-2, and secondary end points include overall survival, response rate and adverse events. Clinical Trial Registration : jRCTs031210365 (https://jrct.niph.go.jp/).
Keyphrases
- phase ii study
- phase iii
- locally advanced
- open label
- clinical trial
- rectal cancer
- phase ii
- placebo controlled
- neoadjuvant chemotherapy
- squamous cell carcinoma
- radiation therapy
- risk factors
- double blind
- patients undergoing
- end stage renal disease
- computed tomography
- study protocol
- ejection fraction
- image quality
- metastatic colorectal cancer
- contrast enhanced
- newly diagnosed
- dual energy
- chronic kidney disease
- magnetic resonance imaging
- positron emission tomography
- peritoneal dialysis
- prognostic factors
- magnetic resonance
- working memory
- lymph node
- combination therapy