NCT06468969Not yet recruiting
Enhanced vs. Routine Follow-Up After Total Gastrectomy for Advanced Gastric Cancer: A Randomized Controlled Trial
A Prospective, Single-Center, Randomized Controlled Trial Comparing Enhanced Follow-up With Standard Follow-up in Post-Gastrectomy Patients With Advanced Gastric Cancer
Source: ClinicalTrials.gov · Last updated 21 Jun 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 158 (estimated)
- First submitted
- 16 Jun 2024
- Start date
- 1 Jul 2024
- Primary completion date
- 1 Jul 2026
- Lead sponsor
- Fudan University
- Diseases
- Gastric and esophageal cancer
- NCT number
- NCT06468969
What you commit to
- Study type: Interventional
- Planned participants: 158
- From 1 Jul 2024 to the primary completion date, 1 Jul 2026
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Participation in another clinical trial within 4 weeks prior to enrollment.
Other illness
- 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.
Other
- Pregnant or breastfeeding.
Who the study is looking for
- 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.
Age in the registry: 18 years to 72 years · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.