Locally Advanced Rectal Cancer
Conditions
Keywords
5-Fluorouracil, rectal cancer, irinotecan, oxaliplatin, neoadjuvant chemotherapy
Brief summary
This study aims to investigate the feasibility, safety and efficacy of triplet regimen of neoadjuvant chemotherapy in patients with locally advanced rectal cancer
Detailed description
In this pilot phase II study, the investigators enrolled Chinese adults(age 18 to 70 years) with locally advanced stage II/III rectal cancer. The neuadjuvant chemotherapy regimen is : oxaliplatin 85 mg/m2 and irinotecan 150 mg/m2, combined with 5FU 2,400 mg/m2 by 46 h infusion, repeated at 2week intervals for 5 cycles. Total mesorectal excision was scheduled 4-5 weeks after completion of neoadjuvant treatment and followed by a further 7 cycles of mFOLFOX or 4 cycles of XELOX. Primary outcome measures of this phase II trial were feasibility, safety, tolerance and efficacy of neoadjuvant treatment.
Interventions
DRUGFOLFOXIRI
oxaliplatin 85 mg/m2 irinotecan 150 mg/m2, 5FU 2,400 mg/m2 by 46 h infusion repeated at 2week intervals
Sponsors
Aiping Zhou
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
1. Histologically confirmed locally advanced rectal cancer; 2. 18-70 years ； 3. Clinicalstage:T3,4a,N0,M0;T1-4a,N+,M0; 4. Tumor from anus \>5cm and ≤15cm; 5. ECOG=0-1; 6. Available organ function:ALT≤1.5xULN;AST≤1.5xULN;TBIL≤1.0xULN; NEUT≥2×109/L;PLT≥100×109/L;Hb≥90g/L;Creatinine≤1.0xULN; 7. Informed consent; 8. UGT1A1:UGT1A1\*1/UGT1A1\*1,UGT1A1\*1/UGT1A1\*28,UGT1A1\*1/UGT1A1\*6;
Exclusion criteria
1. Clinical stage T4b or unresectable disease; 2. History of pelvic radiotherapy; 3. History of chemotherapy within 5 years; 4. History of chronic diarrhea; 5. Tumor causes intestinal obstruction, intestinal perforation, and severe bleeding; 6. Hepatitis B surface antigen positive; Hepatitis C virus infection; Cirrhosis of the liver for any cause; 7. UGT1A1:UGT1A1\*28/UGT1A1\*28,UGT1A1\*6/UGT1A1\*6; 8. Other cancers in the past 5 years, except for cervical carcinoma in situ or non-melanoma skin cancer; 9. Myocardial infarction (in the last 6 months), severe instability angina, congestive heart failure; interstitial pneumonia,pulmonary fibrosis, uncontrolled diabetes, renal insufficiency; 10. Mental illness;Pregnant or lactating women;
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| pCR | 1 year | Pathological complete response according to Mandard tumor regression grading |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| R0 resection rate | 1 year | R0 resection rate |
| locoregional recurrence rate | 1 year | locoregional recurrence rate |
| Safety | 1 year | Including adverse events during neoadjuvant chemotherapy,surgery and perioperative complications |
Countries
China
Outcome results
None listed