NCT05201430 Neoadjuvant FOLFOXIRI Versus CapeOX Chemotherapy for Local Advanced Rectal Cancer
| NCT ID | NCT05201430 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Fudan University |
| Condition | Rectal Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 300 participants |
| Start Date | 2021-08-27 |
| Primary Completion | 2024-06 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 300 participants in total. It began in 2021-08-27 with a primary completion date of 2024-06.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Contact & Investigator
Ye Xu
PRINCIPAL INVESTIGATOR
Fudan University
Frequently Asked Questions
Who can join the NCT05201430 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Rectal Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05201430 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 300 participants.
Is NCT05201430 currently recruiting?
Yes, NCT05201430 is actively recruiting participants. Contact the research team at 11307120071@fudan.edu.cn for enrollment information.
Where is the NCT05201430 trial being conducted?
This trial is being conducted at Shanghai, China.
Who is sponsoring the NCT05201430 clinical trial?
NCT05201430 is sponsored by Fudan University. The principal investigator is Ye Xu at Fudan University. The trial plans to enroll 300 participants.
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