Comparing two chemotherapy regimens for advanced rectal cancer

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

This study tests two different chemotherapy treatments to see which one works better for people with advanced rectal cancer who can have surgery to preserve the anus.

Quick facts

• Phase: Phase 3
• Study type: Interventional
• Enrollment: 300 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Fudan University (Academic / other)
• Drugs / interventions: chemotherapy
• Locations: 1 site (Shanghai, Shanghai Municipality)
• Trial ID: NCT05201430 on ClinicalTrials.gov

What this trial studies

This phase III randomized controlled trial evaluates the effectiveness and safety of two neoadjuvant chemotherapy regimens, FOLFOXIRI and CapeOX, in patients with locally advanced rectal cancer. The study focuses on patients with MRI T3-4 or N+ rectal adenocarcinoma who are candidates for anus-preserving surgery. By optimizing neoadjuvant therapy, the trial aims to improve patient outcomes and prognosis. Participants will be closely monitored for treatment efficacy and safety throughout the study.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 75 with locally advanced rectal adenocarcinoma suitable for radical resection.

Not a fit: Patients with previous systemic chemotherapy for colorectal cancer or those with a life expectancy of less than three months may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved treatment options and outcomes for patients with locally advanced rectal cancer.

How similar studies have performed: Other studies have explored neoadjuvant chemotherapy for rectal cancer, but the specific comparison of FOLFOXIRI and CapeOX is novel.

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.

Where this trial is running

Shanghai, Shanghai Municipality

• Department of Colorectal Surgery Fudan University Shanghai Caner Center — Shanghai, Shanghai Municipality, China (Recruiting)

Study contacts

• Principal investigator: Ye Xu — Fudan University
• Study coordinator: Tianan Guo

Conditions Rectal Cancer; Neoadjuvant chemotherapy; Locally advanced rectal cancer; FOLFOXIRI; CapeOX