Total neoadjuvant therapy for rectal cancer

A Phase II Study of Total Neoadjuvant Therapy in Rectal Cancer

This study is testing a new treatment approach for Taiwanese patients with stage II or III rectal cancer to see if a combination of short radiation and chemotherapy can help them respond better to the therapy.

Quick facts

• Phase: PHASE2
• Study type: Interventional
• Enrollment: 42 (estimated)
• Ages: 20 Years and up
• Sex: All
• Sponsor: National Cheng-Kung University Hospital (other)
• Drugs / interventions: chemotherapy
• Locations: 1 site (Tainan)
• Trial ID: NCT06162650 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are adults aged 20 and older with newly diagnosed stage II or III adenocarcinoma of the rectum located in the mid or low rectum.

Not a fit: Patients with recurrent rectal cancer or those who have received prior treatment for rectal cancer may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could improve treatment outcomes for patients with rectal cancer by increasing the rate of complete responses.

How similar studies have performed: Other studies have shown promise with similar total neoadjuvant therapy approaches, indicating potential for success.

Eligibility criteria

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 this trial is running

Tainan

• 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

Conditions: Rectal Cancer