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Triplet Combination or Doublet Regimen Versus Chemoradiation as Neoadjuvant Therapy for Locally Advanced Rectal Cancer
Sponsor: Sixth Affiliated Hospital, Sun Yat-sen University
Summary
Preoperative radiation with single agent chemotherapy as sensitizer is the standard care of locally advanced rectal cancer. Local irradiation significantly increases surgical complications and impairs quality of life. Combination chemotherapy alone seems promising and provides similar benefit to chemoradiation as neoadjuvant therapy. Early administration of systemic therapy is also proved beneficial for long-term survival. The purpose of this study is to compare the efficacy of chemotherapy alone with short-term modified FOLFOXIRI or long-term mFOLFOX with standard chemoradiation as neoadjuvant therapy for locally advanced rectal cancer.
Official title: A Prospectively Randomized Phase III Trial Comparing Short-term mFOLFOXIRI, Long-term mFOLFOX6 and Traditional Chemoradiation as Preoperative Neoadjuvant Therapy for Locally Advanced Rectal Cancer
Key Details
Gender
All
Age Range
18 Years - 75 Years
Study Type
INTERVENTIONAL
Enrollment
933
Start Date
2019-08
Completion Date
2029-07
Last Updated
2019-06-05
Healthy Volunteers
No
Conditions
Interventions
Chemoradiation
Fluorouracil 225 mg/m2/day continuous intravenous infusion on weekdays for five weeks; local irradiation 2GY/day on weekdays, totally 50GY.
FOLFOXIRI Protocol
Oxaliplatin 85 mg/m2 on day 1; irinotecan 150 mg/m2 on day 1; leucovorin 400 mg/m2 on day 1; fluorouracil 2400 mg/m2 civ over 46h; treatment will be repeated every 14 days; prophylactic G-CSF support is recommended.
Folfox Protocol
Oxaliplatin 85 mg/m2 on day 1; leucovorin 400 mg/m2 on day 1; fluorouracil 400 mg/m2 bolus and 2400 mg/m2 civ over 46h; treatment will be repeated every 14 days.