Clinical trial NCT05201430: Neoadjuvant FOLFOXIRI Versus CapeOX Chemotherapy for Local Advanced Rectal Cancer
Official title: Neoadjuvant FOLFOXIRI Chemotherapy Versus CapeOX Chemotherapy for Local Advanced Rectal Cancer: An Open Label Randomized Controlled Phase III Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Rectal Cancer
Keywords: Neoadjuvant chemotherapy
Locally advanced rectal cancer
FOLFOXIRI
CapeOX
Lead sponsor: Fudan University
Sponsor class: OTHER
First posted: 2022-01-21
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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.

Primary outcomes:
measure: 3-year disease free survival
timeFrame: 3 years
Secondary outcomes:
measure: pathologic complete response rate
timeFrame: 1 year
measure: major pathologic response rate
timeFrame: 1 year
measure: objective response rate
timeFrame: 1 year
measure: local recurrence rate
timeFrame: 3 years
measure: overall survival
timeFrame: 5 years
measure: quality of life as assessed by EORTC QOL-C30
timeFrame: 3 years
measure: quality of life as assessed by EORTC QOL-CR29
timeFrame: 3 years
measure: adverse event
timeFrame: 1 year
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Department of Colorectal Surgery Fudan University Shanghai Caner Center
state: Shanghai
Study officials:
affiliation: Fudan University
name: Ye Xu
role: PRINCIPAL_INVESTIGATOR
References: