Comparing surgery with and without postoperative radiotherapy for esophageal 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 clinical trial aims to evaluate the effectiveness of postoperative radiotherapy (PORT) in improving overall survival for patients with Stage II or III esophageal squamous cell carcinoma who have undergone neoadjuvant chemoradiotherapy. Patients will be randomly assigned to receive either PORT or no PORT after surgery, with the primary outcome being overall survival assessed over a minimum follow-up period of 60 months. The study also aims to assess secondary outcomes such as progression-free survival and recurrence-free survival. The hypothesis is that PORT may reduce recurrence rates and enhance survival compared to surgery alone.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Patients must not have received any prior anticancer therapy Histologically-confirmed squamous cell carcinoma of the esophagus;
2. Tumors of the esophagus are located in the thoracic cavity;
3. Pre-treatment stageⅡ-Ⅲ (AJCC/UICC 8th Edition)
4. Male or non pregnant female
5. Age is between 18 years and 65 years,
6. Eastern Cooperative Oncology Group (ECOG) performance status 0-1 or Karnofsky performance status (KPS) of 70 or more;
7. Adequate bone marrow function (White Blood Cells ≥4x109 /L; Neutrophil ≥1.5×109 /L; Hemoglobin≥ 90 g/L; platelets≥100x109 /L);
8. Adequate liver function (Total bilirubin, Aspartate transaminase(AST) and Alanine transaminase (ALT) ≤2x Upper Level of Normal (ULN));
9. Adequate renal function (serum creatinine (SCr) ≤1.5 x ULN);
10. The patient has provided written informed consent and is able to understand and comply with the study.

Exclusion Criteria:

1. Patients with non-squamous cell carcinoma histology;
2. Patients with advanced inoperable or metastatic esophageal cancer;
3. Patients with another previous or current malignant disease；
4. Any patient with a significant medical condition which is thought unlikely to tolerate the therapies. Such as cardiac disease;
5. Age \>65 years;
6. Pregnant or lactating female or people during the birth-period who refused to take contraceptives;
7. Uncontrolled seizures or psychiatric diseases, loss of control over their own behavior;
8. Patients who refuse surgery after neoadjuvant chemotherapy;
9. Unsuitable to be enrolled in the trial in the opinion of the investigators

Where it's running

• Fujian Medical University Union Hospital
  Fuzhou, Fujian, China Recruiting

Study contacts

• Principal investigator: Benhua Xu, doctor — Fujian Medical University Union Hospital
• Study coordinator: Benhua Xu, doctor
• Email: benhuaxu@163.com
• Phone: +86-13696884375

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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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.