Status:
COMPLETED
Neoadjuvant Triplet Chemotherapy Regimen in Patients With Locally Advanced Rectal Cancer
Lead Sponsor:
Aiping Zhou
Conditions:
Locally Advanced Rectal Cancer
Eligibility:
All Genders
18-70 years
Phase:
PHASE2
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 m...
Eligibility Criteria
Inclusion
- Histologically confirmed locally advanced rectal cancer;
- 18-70 years ；
- Clinicalstage:T3,4a,N0,M0;T1-4a,N+,M0;
- Tumor from anus \>5cm and ≤15cm;
- ECOG=0-1;
- 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;
- Informed consent;
- UGT1A1:UGT1A1\*1/UGT1A1\*1,UGT1A1\*1/UGT1A1\*28,UGT1A1\*1/UGT1A1\*6;
Exclusion
- Clinical stage T4b or unresectable disease;
- History of pelvic radiotherapy;
- History of chemotherapy within 5 years;
- History of chronic diarrhea;
- Tumor causes intestinal obstruction, intestinal perforation, and severe bleeding;
- Hepatitis B surface antigen positive; Hepatitis C virus infection; Cirrhosis of the liver for any cause;
- UGT1A1:UGT1A1\*28/UGT1A1\*28,UGT1A1\*6/UGT1A1\*6;
- Other cancers in the past 5 years, except for cervical carcinoma in situ or non-melanoma skin cancer;
- Myocardial infarction (in the last 6 months), severe instability angina, congestive heart failure; interstitial pneumonia,pulmonary fibrosis, uncontrolled diabetes, renal insufficiency;
- Mental illness;Pregnant or lactating women;
Key Trial Info
Start Date :
February 6 2016
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2020
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT03443661
Start Date
February 6 2016
End Date
April 1 2020
Last Update
February 1 2021
Active Locations (1)
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1
National Cancer Center/Cancer Hospital, Chinese ACademy of Medical Sciences and Peking Union Medical College
Beijing, China, 100021