rectal cancer
Conditions
Interventions
experimental group:neoadjuvant mFOLFOXIRI chemotherapy alone
control group:neoadjuvant mFOLFOX6 chemotherapy alone
Sponsors
Third Affiliated Hospital, Kunming Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: (1) Aged >= 18 to 70 years at diagnosis; (2) Diagnosis of rectal adenocarcinoma (TNM Stage: T3-4NxM0 and MRF positive according to radiology); (3) Distal border of the tumor must be located < 12 cm from the anal verge; (4) ECOG status 0 or 1; (5) Without any anticancer treatment before inclusion; (6) Adequate bone marrow, hepatic and renal function as assessed by the following laboratory requirements conducted within 7 days of starting study treatment; (7) Signed informed consent; able to comply with study and/or follow- up procedures.
Exclusion criteria
Exclusion criteria: (1) Hypersensitivity to fluorouracil, oxaliplatin or irinotecan; (2) With serious basic diseases: heart disease, kidney failure, severe liver dysfunction or liver failure, coagulation dysfunction or oral dose of anticoagulant drugs; (3) Patient had second malignant disease within 5 years; (4) Multiple primary colon cancer patients,or have been systematic chemotherapy; (5) With clinical symptoms requiring emergency surgery for treatment (complete obstruction, bleeding, intestinal perforation); (6) Had metastatic disease; (7) Included in other clinical trails; (8) Pregnant and Nursing women.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| R0 resection rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| objective response rate;tumor regression grade;The incidence of >=3 grade adverse events;rate of anus preservation;pathologic complete response rate;postoperative complications;rate of local recurrence;disease-free survival (Time Frame: 3 years);Overall survival (Time Frame: Three years);disease-free survival (Time Frame: 5 years);Overall survival (Time Frame: 5 years);Distant metastasis rate; | — |
Countries
China
Contacts
Public ContactPing Liu
Outcome results
None listed