Prospectively Randomized Control Clinical Trial of FOLFOXIRI Preoperative Chemotherapy Alone on Rectal Cancer in Local Advance Comparing to Oral Capecitabine Combined With Long-term Radiation
Condition(s) studied
Investigational drug(s) / intervention(s)
FOLFOXIRI: Irinotecan165 mg/m2、Oxaliplatin85 mg/m2、Left-calcium leucovorin 200mg/㎡,Intravenous infusion,first day. Then, 5-FU 1600 mg/m2/d×2 continuous intravenous infusion(total 3200 mg/m2,infusion 46 hours)in the next two days. Repeat every 14 days.
XELOX: XELOX consisting of 130 mg/m2 oxaliplatin administered intravenously on day 1 and 1,000 mg/m2 capecitabine administered orally twice daily on days 1-14 for a 3-week cycle.
Chemoradiotherapy: Chemotherapy: oral capecitabine(1650 mg/m2)twice daily during radiotherapy without weekend breaks. Radiation: Radiation therapy is administered via intensity-modulated radiation therapy (IMRT) with a linear accelerator, 6MV-X ray. The patients are scheduled to receive a GTV expanding 6mm to form PTV1 and CTV expanding 6mm to form PTV2. The dose of PTV1 is 50Gy/25 times for 35 days and the dose of PTV2 is 45Gy/25 times for 35 days. Patients were treated in consecutive days per week for a total of 5 weeks.
TME operation: TME operation
efficacy evaluation: chest/ abdominal CT、pelvic nuclear magnetic resonanceimaging、transrectal ultrasonography
Study summary
Preoperative radiation and chemotherapy is the standard treatment for local advanced rectal cancer. The addition of oxaliplatin to capecitabine combined with radiotherapy does not improve local control and long-term survival. Most importantly,chemoradiotherapy significantly increased surgical complication and poor long-term quality of life .In the absence of effective measures of predicting chemo-sensitivity, there is considerable risk of using any two-drug regimen for neoadjuvant therapy. Simultaneous use of the three chemotherapeutic drugs may be able to reduce the likelihood of resistance to both dual drug regimen and single drug regimen. The purpose of this study is to compare the efficacy and safety of three chemotherapeutic regimen known as FOLFOXIRI (the drug 5-fluorouracil, oxaliplatin, Irinotecan) with standard radiotherapy combined with capecitabine in neoadjuvant therapy for local advanced rectal cancer. The drugs in the FOLFOXIRI regimen are all FDA(Food and Drug Administration) approved and have been used routinely to treat patients with advanced colorectal cancer.
Eligibility
Primary outcome measure(s)
- 3-year disease free survival rate — up to 5 years
3-year disease free survival was defined as the interval from randomization to disease local recurrence and distance metastasis, death, or the last follow-up within 3 years. Patients without any event (metastasis or death) at the last follow-up date were regarded as random censoring.
Trial sites (2)
| Facility | City | Region | Status |
|---|---|---|---|
| Cancer center of Sun Yat-sen University | Guangzhou | Guangdong | Recruiting |
| Medical Oncology,Sun Yat-sen University Cancer Center | Guangzhou | Guangdong | Not Yet Recruiting |
More Sun Yat-sen University trials in China
Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT03671252 on ClinicalTrials.gov ↗ ← All trials in China