Neoadjuvant FOLFOXIRI Versus CapeOX Chemotherapy for Local Advanced Rectal Cancer

Rectal Cancer Clinical Trial

— RCNAC  

Official title:

Neoadjuvant FOLFOXIRI Chemotherapy Versus CapeOX Chemotherapy for Local Advanced Rectal Cancer: An Open Label Randomized Controlled Phase III Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05201430
• Other study ID #: 2108240-5
• Status: Recruiting
• Phase: Phase 3
• Start date: August 27, 2021
• Est. completion date: July 2027

Study information

• Verified date: February 2022
• Source: Fudan University
• Contact: Tianan Guo
• Phone: +86-021-64035387
• Email: 11307120071[@]fudan.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a phase III randomized controlled trial comparing the efficacy and safety of FOLFOXIRI versus CapeOX as neoadjuvant regimen in treating patients with middle and upper locally advanced (MRI T3-4 or N+) rectal cancer. This study aims to optimize the neoadjuvant therapy for patients with anus-preserving resectable locally advanced rectal cancer, so as to improve the prognosis of them. It remains unclear about whether FOLFOXIRI or CapeOX neoadjuvant chemotherapy is more effective for locally advanced rectal cancer.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: July 2027
• Est. primary completion date: June 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• MRI evaluated of T3-4 or N+ rectal cancer;

• Pathologically diagnosed of rectal adenocarcinoma;

• 18 to 75 years old;

• Distance from lower margin of tumor to anus <15 cm and suitable for anus-preserving resection;

• Tumor amenable to radical resection;

• Treatment-na?ve patients with no previous systemic chemotherapy, radiotherapy or local excision for treating rectal cancer;

• Laboratory requirements conducted within 7 days of starting study treatment:

Neutrophil count = 1.5×10^9/L, Platelet count = 100×10^9 /L, Hemoglobin = 80 g/L, Serum bilirubin = 24umol/L, Alanine aminotransferase and aspartate aminotransferase = 60 U/L, Serum creatinine = 110 umol/L;

• Be capable to receive a surgery;

• No second tumor at present or in the past 5 years, except skin basal cell carcinoma, skin squamous cell carcinoma, or any in situ cancer;

• No previous systemic chemotherapy for treating colorectal cancer;

• Life expectancy of more than 3 months;

• No current pregnancy or breast-feeding, and subjects at childbearing age shall take method of contraception;

• Eastern Cooperative Oncology Group (ECOG) performance status (PS) = 1;

• Be willing and able to understand the study and to provide written informed consent.

Exclusion Criteria:

• End-stage cachexia patients;

• Cardiopulmonary dysfunction or liver and kidney dysfunction, and unable to tolerate chemotherapy or surgery;

• Metastatic carcinoma;

• Incomplete or complete intestinal obstruction;

• Known to be allergic to capecitabine, 5-Fu, oxaliplatin or irinotecan;

• Pregnant or lactating women; or women who have fertility but have not taken at taken adequate contraceptive measures;

• Have vital organ failure or other severe diseases, including but not limited to coronary heart disease, cardiovascular diseases, or myocardial infarction within 12 months before being included; severe neurological or psychiatric historysevere infection; active disseminated intravascular coagulation; active hepatitis, severe coagulation disorder patients;

• History of other malignancy within the past 5 years except effectively treated skin basal cell carcinoma, skin squamous cell carcinoma, or any in situ cancer;

• Serious organic disease including but not limited to heart, kidney, brain, and lung.

Related Conditions & MeSH terms

• Rectal Cancer
• Rectal Neoplasms

Intervention

Drug:
• FOLFOXIRI
irinotecan* 165 mg/m² iv continue for 1.5 hours, D1 oxaliplatin 85 mg/m² iv continue for 2 hours, D1 leucovorin 400 mg/m² iv continue for 2 hours, D1 5-FU 2400~3200 mg/m² cont. inf. 48h, D1 repeat every 2 weeks (Q2W)
• CapeOX
oxaliplatin 130 mg/m2 iv continue for 2 hours, D1 capecitabine 1000mg/m2/d PO Bid, once every morning and evening D1-14 repeat every 3 weeks (Q3W)

Locations

Country	Name	City	State
China	Department of Colorectal Surgery Fudan University Shanghai Caner Center	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Fudan University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	3-year disease free survival	Defined as the length of time from the date of randomization until the first documented date of progression or death from any cause, whichever comes first. Compare 3-year disease free survival in patients with locally advanced rectal cancer treated with either FOLFOXIRI or CapeOX neoadjuvant chemotherapy.	3 years
Secondary	pathologic complete response rate	Defined as the ratio of patients with pathologic TRG 0	1 year
Secondary	major pathologic response rate	Defined as the ratio of patients with pathologic TRG 0 or 1	1 year
Secondary	objective response rate	Defined as the ratio of patients with MRI-TRG 1, 2 or 3	1 year
Secondary	local recurrence rate	Defined as the ratio of patients with local recurrence within 3 years.	3 years
Secondary	overall survival	Defined as the length of time from randomization date until the date of death from any cause.	5 years
Secondary	quality of life as assessed by EORTC QOL-C30	Quality of life after neoadjuvant chemotherapy is assessed by questionaires EORTC QOL-C30 version 3	3 years
Secondary	quality of life as assessed by EORTC QOL-CR29	Quality of life after neoadjuvant chemotherapy is assessed by questionaires EORTC QOL-CR29.	3 years
Secondary	adverse event	Number of patients with adverse events and severity according to NCI CTC 5.0 after neoadjuvant chemotherapy.	1 year