Not Yet RecruitingNot Applicable

Enhanced vs. Routine Follow-Up After Total Gastrectomy for Advanced Gastric Cancer: A Randomized Controlled Trial

158 participantsStarted 2024-07-01

Plain-language summary

The goal of this clinical trial is to compare the effectiveness of enhanced follow-up with standard follow-up in postoperative patients with advanced gastric cancer who have undergone radical gastrectomy. The main questions it aims to answer are: Can enhanced follow-up alleviate symptom burden and improve quality of life? What is the impact of enhanced follow-up on overall survival rates at 3 and 5 years post-surgery? Participants will: Be randomly assigned to either the enhanced follow-up group or the standard follow-up group. Undergo comprehensive symptom, nutritional, and psychological assessments every 3 weeks (enhanced follow-up group). Receive routine postoperative follow-up including medical examinations and treatments as needed, with additional assessments only when necessary (standard follow-up group). Researchers will compare the enhanced follow-up group with the standard follow-up group to see if enhanced follow-up can improve quality of life and increase overall survival rates at 3 and 5 years post-surgery. Outcomes will be measured using the EORTC QLQ-C30 quality of life questionnaire and overall survival rates. This prospective, single-center, randomized controlled clinical trial will span 5 years from the approval by the institutional ethics committee and will include 158 patients.

Who can participate

Age range

18 Years – 72 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: * Age: 18 to 72 years at the time of informed consent. * Underwent radical total gastrectomy. * Postoperative pathology confirmed advanced adenocarcinoma of the stomach or gastroesophageal junction. * Estimated survival time ≥3 months. * Good cognitive and reading abilities, capable of completing questionnaires. * Willing and able to provide written informed consent for the study. Exclusion Criteria: * Participation in another clinical trial within 4 weeks prior to enrollment. * Patients with other malignancies. * Clinically significant cardiovascular disease, such as heart failure (NYHA III-IV), uncontrolled coronary artery disease, cardiomyopathy, arrhythmia, or hypertension. * Neurological or psychiatric disorders affecting cognitive function, including central nervous system metastasis. * Active infectious diseases, such as active hepatitis or tuberculosis. * Uncontrolled systemic diseases, such as poorly controlled diabetes. * Interstitial lung disease, such as interstitial pneumonia, pulmonary fibrosis, or evidence of interstitial lung disease on baseline chest X-ray/CT. * Pregnant or breastfeeding.

Questions worth asking your doctor

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

Quality of Life Improvement

Timeframe: Assessed every 6 weeks from the 4th week post-surgery until 6 months post-chemotherapy completion.

Trial details

NCT IDNCT06468969

SponsorFudan University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-07-01

Contact for this trial

Bo Sun, MD, PHD

18521064063 15111220073@fudan.edu.cn

View on ClinicalTrials.gov More Gastric Cancer trials