Comparing surgery with and without postoperative radiotherapy for esophageal cancer

Prospective Randomized Controlled Trial of Postoperative Radiotherapy in Thoracic Esophageal Squamous Cell Carcinoma With Neoadjuvant Chemoradiotherapy

This study is testing if adding radiation treatment after surgery can help people with Stage II or III esophageal cancer live longer and have fewer cancer recurrences.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 537 (estimated)
• Ages: 18 Years to 65 Years
• Sex: All
• Sponsor: Fujian Medical University Union Hospital (Academic / other)
• Drugs / interventions: chemotherapy, radiation
• Locations: 1 site (Fuzhou, Fujian)
• Trial ID: NCT03734952 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 to 65 with histologically confirmed squamous cell carcinoma of the esophagus at stages II or III.

Not a fit: Patients with non-squamous cell carcinoma or those with advanced disease may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved survival rates for patients with esophageal squamous cell carcinoma.

How similar studies have performed: While neoadjuvant chemoradiotherapy has shown benefits in other studies, the specific approach of combining PORT with nCRT in esophageal squamous cell carcinoma is novel and has not been extensively tested.

Eligibility criteria

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 this trial is running

Fuzhou, Fujian

• 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

Conditions Radiation Oncology