Status:
RECRUITING
Neoadjuvant FOLFOXIRI Versus CapeOX Chemotherapy for Local Advanced Rectal Cancer
Lead Sponsor:
Fudan University
Conditions:
Rectal Cancer
Eligibility:
All Genders
18-75 years
Phase:
PHASE3
Brief Summary
This is a phase III randomized controlled trial comparing the efficacy and safety of FOLFOXIRI versus CapeOX as neoadjuvant regimen in treating patients with middle and upper locally advanced (MRI T3-...
Eligibility Criteria
Inclusion
- MRI evaluated of T3-4 or N+ rectal cancer;
- Pathologically diagnosed of rectal adenocarcinoma;
- 18 to 75 years old;
- Distance from lower margin of tumor to anus \<15 cm and suitable for anus-preserving resection;
- Tumor amenable to radical resection;
- Treatment-na?ve patients with no previous systemic chemotherapy, radiotherapy or local excision for treating rectal cancer;
- Laboratory requirements conducted within 7 days of starting study treatment: Neutrophil count ≥ 1.5×10\^9/L, Platelet count ≥ 100×10\^9 /L, Hemoglobin ≥ 80 g/L, Serum bilirubin ≤ 24umol/L, Alanine aminotransferase and aspartate aminotransferase ≤ 60 U/L, Serum creatinine ≤ 110 umol/L;
- Be capable to receive a surgery;
- No second tumor at present or in the past 5 years, except skin basal cell carcinoma, skin squamous cell carcinoma, or any in situ cancer;
- No previous systemic chemotherapy for treating colorectal cancer;
- Life expectancy of more than 3 months;
- No current pregnancy or breast-feeding, and subjects at childbearing age shall take method of contraception;
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) ≤ 1;
- Be willing and able to understand the study and to provide written informed consent.
Exclusion
- End-stage cachexia patients;
- Cardiopulmonary dysfunction or liver and kidney dysfunction, and unable to tolerate chemotherapy or surgery;
- Metastatic carcinoma;
- Incomplete or complete intestinal obstruction;
- Known to be allergic to capecitabine, 5-Fu, oxaliplatin or irinotecan;
- Pregnant or lactating women; or women who have fertility but have not taken at taken adequate contraceptive measures;
- Have vital organ failure or other severe diseases, including but not limited to coronary heart disease, cardiovascular diseases, or myocardial infarction within 12 months before being included; severe neurological or psychiatric historysevere infection; active disseminated intravascular coagulation; active hepatitis, severe coagulation disorder patients;
- History of other malignancy within the past 5 years except effectively treated skin basal cell carcinoma, skin squamous cell carcinoma, or any in situ cancer;
- Serious organic disease including but not limited to heart, kidney, brain, and lung.
Key Trial Info
Start Date :
August 27 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2027
Estimated Enrollment :
300 Patients enrolled
Trial Details
Trial ID
NCT05201430
Start Date
August 27 2021
End Date
July 1 2027
Last Update
March 4 2022
Active Locations (1)
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1
Department of Colorectal Surgery Fudan University Shanghai Caner Center
Shanghai, Shanghai Municipality, China, 200032