Neoadjuvant Triplet Chemotherapy Regimen in Patients With Locally Advanced Rectal Cancer

Locally Advanced Rectal Cancer Clinical Trial

Official title:

A Pilot Phase II Study of Neoadjuvant Triplet Chemotherapy Regimen （FOLFOXIRI） in Patients With Locally Advanced Rectal Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03443661
• Other study ID #: CH-GI-086
• Status: Completed
• Phase: Phase 2
• Start date: February 6, 2016
• Est. completion date: April 1, 2020

Study information

• Verified date: January 2021
• Source: Chinese Academy of Medical Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study aims to investigate the feasibility, safety and efficacy of triplet regimen of neoadjuvant chemotherapy in patients with locally advanced rectal cancer

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: April 1, 2020
• Est. primary completion date: March 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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;

Related Conditions & MeSH terms

• Locally Advanced Rectal Cancer
• Rectal Neoplasms

Intervention

Drug:
• FOLFOXIRI
oxaliplatin 85 mg/m2 irinotecan 150 mg/m2, 5FU 2,400 mg/m2 by 46 h infusion repeated at 2week intervals

Locations

Country	Name	City	State
China	National Cancer Center/Cancer Hospital, Chinese ACademy of Medical Sciences and Peking Union Medical College	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Aiping Zhou

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	pCR	Pathological complete response according to Mandard tumor regression grading	1 year
Secondary	R0 resection rate	R0 resection rate	1 year
Secondary	locoregional recurrence rate	locoregional recurrence rate	1 year
Secondary	Safety	Including adverse events during neoadjuvant chemotherapy,surgery and perioperative complications	1 year