Total neoadjuvant therapy for rectal cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This phase 2 study investigates the efficacy of total neoadjuvant therapy in Taiwanese patients diagnosed with stage II or III middle or low rectal cancer. Participants will receive a short-course radiotherapy followed by chemotherapy using the mFOLFOX6 regimen. The study aims to evaluate the complete response rate, considering both clinical and pathological responses. It will enroll 42 subjects over a period of two years and follow their clinical outcomes for an additional five years.

Why it matters

Who can join: the full rules

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.

Where it's running

• National Cheng Kung University Hospital
  Tainan, Taiwan Recruiting

Study contacts

• Principal investigator: Yu-Min Yeh, MD — National Cheng-Kung University Hospital
• Study coordinator: Yu-Min Yeh, MD
• Email: i5485111@gmail.com
• Phone: +886 353535

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.