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RECRUITING
NCT06162650
PHASE2

Total Neoadjuvant Therapy in Rectal Cancer

Sponsor: National Cheng-Kung University Hospital

View on ClinicalTrials.gov

Summary

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.

Official title: A Phase II Study of Total Neoadjuvant Therapy in Rectal Cancer

Key Details

Gender

All

Age Range

20 Years - Any

Study Type

INTERVENTIONAL

Enrollment

42

Start Date

2023-11-16

Completion Date

2030-11-16

Last Updated

2026-04-08

Healthy Volunteers

No

Conditions

Interventions

RADIATION

Short-course radiotherapy

Short-course radiotherapy, 5×5 Gy.

DRUG

mFOLFOX6

Oxaliplatin 85 mg/m2, leucovorin 400 mg/m2, infusinal 5-fluorouracil 2400 mg/m2 every 2 weeks, for 9 cycles

Locations (1)

National Cheng Kung University Hospital

Tainan, Taiwan