RecruitingPhase 2NCT06162650

Total Neoadjuvant Therapy in Rectal Cancer

A Phase II Study of Total Neoadjuvant Therapy in Rectal Cancer


Sponsor

National Cheng-Kung University Hospital

Enrollment

42 participants

Start Date

Nov 16, 2023

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 20 Years

Plain Language Summary

Simplified for easier understanding

This study tests a "total neoadjuvant therapy" (TNT) approach — delivering all or most cancer treatment (chemotherapy and radiation) before surgery — for rectal cancer patients. The goal is to improve tumor shrinkage and potentially allow organ-preserving approaches in patients who respond completely. **You may be eligible if...** - You are 18–75 with locally advanced rectal cancer (cancer that has grown into surrounding tissue or lymph nodes) - You have not had prior treatment for this cancer - Your general health allows chemotherapy and radiation **You may NOT be eligible if...** - Your cancer has spread to distant organs (Stage IV) - You have had prior pelvic radiation - You have serious heart, liver, kidney, or blood disorders - You are pregnant - You have an active second cancer Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

RADIATIONShort-course radiotherapy

Short-course radiotherapy, 5×5 Gy.

DRUGmFOLFOX6

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

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NCT06162650


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