Total Neoadjuvant Therapy in Rectal Cancer

In this phase 2 study, the efficacy of total neoadjuvant therapy in Taiwanese patients with rectal cancer will be investigated. Patients with stage II or III middle/low rectal cancer will be prospective enrolled. The total neoadjuvant therapy with the short-course radiotherapy (5×5 Gy over a maximum of 8 days) followed by chemotherapy with mFOLFOX6 for 9 cycles will be administered. The primary endpoint is the complete response (CR) rate which will take into account the patients with clinical and pathological complete response.

Trial Details

NCT ID
NCT06162650
Phase
PHASE2
Sponsor
National Cheng-Kung University Hospital
Status
RECRUITING
Cancer Type
Colorectal Cancer
Interventions
  • Short-course radiotherapy
  • mFOLFOX6
Locations (sample)
  • Tainan, Taiwan|22.99083,120.21333

Key Eligibility Criteria

  • Histologically confirmed diagnosis of adenocarcinoma of the rectum;
  • Tumors located at mid or low rectum (distal extension less than 10 cm from the anal verge);
  • Clinical stage II or III (T3/4 and/or N+; no distant metastasis);
  • No prior chemotherapy, radiotherapy or surgery for rectal cancer;

For full eligibility, visit ClinicalTrials.gov.

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