Clinical trial NCT03443661: Neoadjuvant Triplet Chemotherapy Regimen in Patients With Locally Advanced Rectal Cancer
Official title: A Pilot Phase II Study of Neoadjuvant Triplet Chemotherapy Regimen （FOLFOXIRI） in Patients With Locally Advanced Rectal Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Locally Advanced Rectal Cancer
Keywords: 5-Fluorouracil
rectal cancer
irinotecan
oxaliplatin
neoadjuvant chemotherapy
Lead sponsor: ChineseAMS
Sponsor class: UNKNOWN
First posted: 2018-02-23
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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;

Primary outcomes:
measure: pCR
timeFrame: 1 year
Secondary outcomes:
measure: R0 resection rate
timeFrame: 1 year
measure: locoregional recurrence rate
timeFrame: 1 year
measure: Safety
timeFrame: 1 year
Other outcomes:
Locations:
city: Beijing
country: China
facility: National Cancer Center/Cancer Hospital, Chinese ACademy of Medical Sciences and Peking Union Medical College
Study officials:
affiliation: China National Cancer Center/Cancer Hospital, Chinese ACademy of Medical Sciences and Peking Union Medical College
name: Aiping Zhou, Doctor
role: PRINCIPAL_INVESTIGATOR
References: