Actively Recruiting

Phase 2
Age: 20Years +
All Genders
NCT06162650

Total Neoadjuvant Therapy in Rectal Cancer

Led by National Cheng-Kung University Hospital · Updated on 2026-04-08

42

Participants Needed

1

Research Sites

365 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Total Neoadjuvant Therapy in Rectal Cancer

Who Can Participate

Age: 20Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

Inclusion 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;
  • Age ≥20;
  • ECOG 0-1;
  • Adequate organ function, including followings:

ANC ≥1,500/μL; Hb ≥8.0 gm/dL; Platelet 100,000/mm3; Total bilirubin ≤1.5x upper normal limit; AST ≤3x upper normal limit; ALT ≤3x upper normal limit; Creatinine ≤1.5x upper normal limit;

  • Ability to understand and the willingness to sing a written informed consent.

Exclusion criteria

  • Recurrent rectal cancer;
  • Patients who have concomitant malignancies, except for adequately treated basal cell carcinoma of the skin or in situ carcinoma of the cervix. Subjects who have prior malignancies and have been disease-free for more than 5 years can be enrolled;
  • Patients who have received prior pelvic radiotherapy;
  • Patients with active infection requiring intravenous antibiotic treatment;
  • Patients with a history of any arterial thrombotic event within the past 6 months, including unstable angina, myocardial infarction (MI) or cerebrovascular accident (CVA), New York Hear Association (NYHA) grade II or greater congestive heart failure, or uncontrolled cardiac arrhythmia;
  • Patients with any other concurrent medical or psychiatric condition or disease which, in the investigator's judgement, would make them inappropriate candidates for entry into this study;
  • Women who are pregnant or breastfeeding. Women of childbearing potential who are unwilling or unable to use an acceptable method of birth control to avoid pregnancy for the entire study period;
  • Patients receiving other anticancer or experimental therapy;
  • Known DPD deficiency or hypersensitivity to oxaliplatin;
  • Any contraindications to MRI.
Not Eligible

You will not qualify if you...

History of severe allergic reactions to study medication Currently pregnant or breastfeeding Recent participation in another clinical trial within the last 30 days Presence of uncontrolled medical conditions that could affect safety

AI-Screening

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Trial Site Locations

Total: 1 location

1

National Cheng Kung University Hospital

Tainan, Taiwan, 704

Actively Recruiting

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Research Team

Y

Yu-Min Yeh, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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Total Neoadjuvant Therapy in Rectal Cancer | DecenTrialz