Observational study on chemo-radiotherapy for early-stage esophageal cancer after endoscopic dissection
Multicenter Cohort Study of Chemo-radiotherapy After Endoscopic Submucosal Dissection for High-risk Early-stage Esophageal Cancer
This study is testing new treatment plans for patients with high-risk early-stage esophageal cancer after surgery to see if they can improve recovery while reducing side effects.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 120 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Second Affiliated Hospital, School of Medicine, Zhejiang University Academic / other |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 2 sites (Hangzhou, Zhejiang and 1 other locations) |
| Trial ID | NCT06385717 on ClinicalTrials.gov |
What this trial studies
This multicenter, prospective observational cohort study aims to optimize individualized chemoradiotherapy regimens for patients with high-risk early-stage esophageal cancer who have undergone endoscopic submucosal dissection. The study focuses on improving local-regional lymph node control rates while minimizing the toxicity associated with chemoradiotherapy. By analyzing patient outcomes, the study seeks to enhance treatment strategies and provide tailored approaches for better management of this condition.
Who should consider this trial
Good fit: Ideal candidates include patients with pathologically confirmed pT1a-MM or pT1b stage esophageal cancer who have refused surgery after endoscopic submucosal dissection.
Not a fit: Patients with severe comorbidities, previous malignancies, or those who have undergone prior radiation or chemotherapy may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to more effective and less toxic treatment options for patients with early-stage esophageal cancer.
How similar studies have performed: Other studies have shown promise in optimizing treatment for esophageal cancer, but this specific approach remains novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 1\. Esophageal cancer patients who are pathologically confirmed as pT1a-MM stage or pT1b stage after endoscopic submucosal dissection； 2. No definite contraindications for chemo-radiotherapy； 3. Informed consent has been signed； 4. Refused surgery after endoscopic submucosal dissection. Exclusion Criteria: * 1\. Severe heart, brain, lung disease or renal dysfunction; 2. Previous history of other malignancies; 3. Prior radiation or chemotherapy 4. Researchers consider it inappropriate to participate in this experiment
Where this trial is running
Hangzhou, Zhejiang and 1 other locations
- The Second Affiliated Hospital of Zhejiang University School of Medicine — Hangzhou, Zhejiang, China (Recruiting)
- The Second Affiliated Hospital of Zhejiang University, School of Medicine — Hangzhou, China (Not_yet_recruiting)
Study contacts
- Study coordinator: Jing Xu, MD
- Email: jing_xu@zju.edu.cn
- Phone: 0086-0571-87783521
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.