Actively Recruiting
Neoadjuvant FOLFOXIRI Versus CapeOX Chemotherapy for Local Advanced Rectal Cancer
Led by Fudan University · Updated on 2022-03-04
300
Participants Needed
1
Research Sites
304 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Neoadjuvant FOLFOXIRI Versus CapeOX Chemotherapy for Local Advanced Rectal Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- MRI evaluation showing T3-4 or N+ rectal cancer
- Pathological diagnosis of rectal adenocarcinoma
- Age between 18 and 75 years
- Tumor located less than 15 cm from the anus and suitable for anus-preserving resection
- Tumor suitable for radical surgery
- No prior systemic chemotherapy, radiotherapy, or local excision for rectal cancer
- Laboratory tests within 7 days before treatment meeting specific blood counts and organ function levels
- Able to undergo surgery
- No second tumor currently or within past 5 years except certain skin cancers or in situ cancers
- Life expectancy over 3 months
- Not pregnant or breastfeeding; use contraception if of childbearing potential
- ECOG performance status of 0 or 1
- Able and willing to provide written informed consent
You will not qualify if you...
- End-stage cachexia
- Cardiopulmonary, liver, or kidney dysfunction preventing chemotherapy or surgery
- Metastatic cancer
- Intestinal obstruction (complete or incomplete)
- Allergy to capecitabine, 5-FU, oxaliplatin, or irinotecan
- Pregnancy or lactation, or inadequate contraception in women of childbearing potential
- Severe diseases including recent heart conditions, severe neurological or psychiatric history, severe infections, bleeding disorders, or active hepatitis
- History of other malignancies within 5 years except certain treated skin or in situ cancers
- Serious organ diseases including heart, kidney, brain, or lung conditions
AI-Screening
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Trial Site Locations
Total: 1 location
1
Department of Colorectal Surgery Fudan University Shanghai Caner Center
Shanghai, Shanghai Municipality, China, 200032
Actively Recruiting
Research Team
T
Tianan Guo
CONTACT
Y
Ye Xu
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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