Postoperative Radiotherapy in Thoracic Esophageal Squamous Cell Carcinoma With Neoadjuvant Chemoradiotherapy

Not Applicable

Recruiting

• Conditions: Radiation Oncology
• Interventions: Drug: Neoadjuvant chemotherapy Program; Radiation: Postoperative radiotherapy program

• Registration Number: NCT03734952
• Lead Sponsor: Fujian Medical University Union Hospital

Brief Summary

The primary objective is to compare surgery with postoperative radiotherapy (PORT) versus surgery, in terms of the overall survival time (OS) in Stage II or III squamous cell esophageal carcinoma with neoadjuvant chemoradiotherapy(nCRT).

Detailed Description

Esophageal squamous cell carcinoma (ESCC) is a common type of esophageal carcinoma in China, which is characterized by rapid development and fatal prognosis in most patients. Neoadjuvant chemoradiotherapy (nCRT) has been explored for many years in western countries and Japan, and proved to get survival benefit, especially for locally advanced esophageal cancer. However, the recurrence is the major cause of treatment failure in patients with ESCC. Our hypothesis is that inadequate radiation dose leads to recurrence of ESCC with nCRT and PORT lower recurrence rate and improved OS. As is known, there are no any studies concentrating on PORT in ESCC with nCRT. Patients are randomly assigned to PORT (Group A) or without PORT (Group B) with a 1:1 allocation ratio. The primary outcome is OS assessed with a minimum follow-up of 60 months. Secondary outcomes are progression-free survival (PFS), recurrence-free survival (RFS).

Study Timeline

• Study First Submitted: 2018-10-26
• Study First Submitted QC: 2018-11-06
• Study First Posted: 2018-11-08
• Study Start: 2023-05-01
• Status Verified: 2023-09
• Last Update Submitted: 2023-09-22
• Last Update Posted: 2023-09-25
• Primary Completion: 2029-01-01
• Study Completion: 2029-01-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 537

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group A	Postoperative radiotherapy program	Neoadjuvant Radiotherapy Program+Neoadjuvant chemotherapy Program+ Esophagectomy program+Postoperative radiotherapy program
Group A	Neoadjuvant chemotherapy Program	Neoadjuvant Radiotherapy Program+Neoadjuvant chemotherapy Program+ Esophagectomy program+Postoperative radiotherapy program
Group B	Neoadjuvant chemotherapy Program	Neoadjuvant Radiotherapy Program+Neoadjuvant chemotherapy Program+ Esophagectomy program

Primary Outcome Measures

Name	Time	Method
overall survival	From enrollment to 5 years after the end of treatment	The length of time from enrollment until the time of death

Secondary Outcome Measures

Name	Time	Method
disease free survival	From enrollment to 5 years after the end of treatment	The length of time from enrollment until the time of progression of disease
local recurrence rate	From enrollment to 5 years after the end of treatment	The percent of the patient with local recurrence
Side effects	From enrollment to 12 weeks after end of the treatment	adverse events according to NCI CTCAE 4.0 criteria

Trial Locations

Locations (1)

Fujian Medical University Union Hospital; 🇨🇳 Fuzhou, Fujian, China