Dietary Arginine Deprivation Combined With Chemoradiotherapy for Neoadjuvant Treatment of Rectal … (NCT07755124) | Clinical Trial Compass
Not Yet RecruitingPhase 1/2
Dietary Arginine Deprivation Combined With Chemoradiotherapy for Neoadjuvant Treatment of Rectal Cancer: A Randomized Controlled Trial
140 participantsStarted 2026-08-14
Plain-language summary
This study evaluates whether an arginine-free diet combined with chemoradiotherapy can improve treatment outcomes in patients with locally advanced rectal cancer. Our previous study showed that an arginine-free diet is safe and may boost the body's immune response against tumors.
The study has two phases. The first phase (6 patients) tests the safety of the diet. The second phase (134 patients) randomly assigns participants to receive either the arginine-free diet plus standard chemoradiotherapy or standard chemoradiotherapy alone.
The arginine-free diet is provided as a liquid nutritional formula for 4 weeks. The main goal is to see if the diet increases the complete response rate (tumor disappearance). We will also evaluate survival outcomes, side effects, and quality of life.
Who can participate
Age range
18 Years – 80 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. ANC ≥ 1.5 × 10⁹/L (no G-CSF within 14 days);
. Platelet count ≥ 100 × 10⁹/L;
. Hemoglobin ≥ 9 g/dL (no transfusion or erythropoietin within 7 days);
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Complete Response (CR) Rate (pCR + cCR)
Timeframe: From enrollment to postoperative pathological assessment, approximately 6 months