Megestrol acetate to prevent weight loss during preoperative chemotherapy for locally advanced colorectal 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 is an open-label, multicenter, randomized Phase 3 trial comparing standard neoadjuvant mFOLFOX6 chemotherapy alone versus mFOLFOX6 combined with oral megestrol acetate 625 mg/day given during the six neoadjuvant cycles. Eligible patients are randomized 1:1 and all undergo planned radical surgery after completing neoadjuvant therapy, with pathological response guiding further adjuvant treatment. The study measures changes in weight, appetite, nutritional status, and chemotherapy-related gastrointestinal toxicities, while monitoring safety of megestrol acetate. Outcomes include rates of weight loss prevention, treatment tolerability, pathological complete response, and postoperative recovery metrics.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Adult males and females aged between 18 and 75 years old.
* Histologically confirmed colorectal adenocarcinoma.
* Immunohistochemistry showing pMMR or MSI status determined as MSS.
* Clinical stage cTxN1-2M0, with or without MRF positivity, and with or without EMVI positivity.
* ECOG performance status 0-1, with a life expectancy of ≥6 months.
* Deemed suitable for preoperative mFOLFOX6 neoadjuvant chemotherapy following multidisciplinary team discussion.
* Written informed consent has been obtained from the patients.

Exclusion Criteria:

* Patients with cardiac arrhythmias requiring anti-arrhythmic treatment (excluding β-blockers or digoxin), symptomatic coronary artery disease or myocardial ischemia (myocardial infarction within the past 6 months), or congestive heart failure greater than NYHA Class II.
* Patients with poorly controlled severe hypertension.
* Patients with a history of HIV infection or active chronic hepatitis B or C (with high-copy viral DNA).
* Patients with active tuberculosis (TB) who are receiving anti-tuberculosis treatment or have received anti-tuberculosis treatment within 1 year prior to screening.
* Patients with other active severe clinical infections (per NCI-CTC v.5.0).
* Patients who have previously received chemotherapy.
* Patients with a history of seizures requiring treatment (e.g., steroids or anti-epileptic therapy).
* Patients with drug abuse or medical, psychological, or social conditions that may interfere with study participation or outcome assessment.
* Patients with a known or suspected allergy to the study drug or any agents administered in relation to the trial.
* Patients with any unstable condition that may jeopardize patient safety or compliance.
* Pregnant or breastfeeding women, or fertile women not using adequate contraception.
* Patients who refuse to sign the informed consent form.

Where it's running

• The Sixth Affiliated Hospital of Sun-Yat sen University
  Guangzhou, Guangdong, China Recruiting

Study contacts

• Principal investigator: Jun Huang, PhD. — Sun Yat-sen University
• Study coordinator: Jun Huang, PhD.
• Email: huangj97@mail.sysu.edu.cn
• Phone: +86-13926451242

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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.