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

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 t

Trial Details

NCT ID

NCT03671252

Phase

PHASE3

Sponsor

Sun Yat-sen University

Status

RECRUITING

Cancer Type

Colorectal Cancer

Interventions

FOLFOXIRI
XELOX
Chemoradiotherapy
TME operation
efficacy evaluation

Locations (sample)

Guangzhou, Guangdong, China|23.11667,113.25
Guangzhou, Guangdong, China|23.11667,113.25

Key Eligibility Criteria

1）Age: 18 to 75 years old;
2）Histological diagnosis of rectal adenocarcinoma;
3）Distance form anal margin ≤ 5cm: cT3-4aN + M0, there is no distant metastasis, lymph node positive, or the tumor breaking through the muscular la…
4）From the anal margin\>5cm: cT3c-4aN+M0, there is no distant metastasis, lymph node positive, or the tumor breaking through the muscular layer wit…

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