Enhanced vs. Routine Follow-Up After Total Gastrectomy for Advanced Gastric Cancer: A Randomized Controlled Trial
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-72
SponsorFudan University
About this trial
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.
Eligibility criteria
Qualifiers
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Enhanced Follow-up
Treatment groups
158 Participants
are divided into 2 treatment groupsLocations
Sponsors and collaborators
Source ClinicalTrials.gov