Neoadjuvant mFOLFOXIRI Plus Bevacizumab in Patients With High-Risk Locally Advanced Rectal Cancer

Multimodality treatment that comprises preoperative fluoropyrimidine with concurrent radiotherapy followed by total mesorectal excision (TME) surgery and adjuvant fluoropyrimidine-based chemotherapy is recommended as a standard treatment of patients with stage II/III rectal cancer. However, the main target of radiotherapy is local control but no improvement in disease-free survival (DFS) or overall survival (OS) has been shown with this treatment strategy, which leaves approximately 30% of patients in whom distant metastases will develop. Moreover, the short- and long-term adverse effects of r

Trial Details

NCT ID
NCT04215731
Phase
PHASE3
Sponsor
Yanhong Deng
Status
RECRUITING
Cancer Type
Colorectal Cancer
Interventions
  • Neoadjuvant chemotherapy with mFOLFOXIRI plus bevacizumab
  • Restaging
  • Concomitant Chemoradiotherapy
  • Surgery
  • Chemoradiotherapy (only when patients with MRF involved or ycT4a/b by restaging)
  • Induction chemotherpay with FOLFOX
Locations (sample)
  • Guangzhou, Guangdong, China|23.11667,113.25

Key Eligibility Criteria

  • Willing and able to provide written informed consent.
  • Male or female subjects \> 18 years \< 70 of age.
  • Histological or cytological documentation of adenocarcinoma of the rectal (\<12 cm from the anal verge).
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.

For full eligibility, visit ClinicalTrials.gov.

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