Postoperative Radiotherapy in Thoracic Esophageal Squamous Cell Carcinoma With Neoadjuvant Chemoradiotherapy
Recruiting now · Not applicable
Conditions studied: Radiation Oncology
In brief
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).
Key facts
- Study ID
- NCT03734952
- Run by
- Fujian Medical University Union Hospital
- People needed
- 537
- Starts
- 2023-05-01
- Expected to finish
- 2029-01-01
- Last updated by the study team
- 2023-09-25
Who can join
Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Patients must not have received any prior anticancer therapy Histologically-confirmed squamous cell carcinoma of the esophagus;
- Tumors of the esophagus are located in the thoracic cavity;
- Pre-treatment stageⅡ-Ⅲ (AJCC/UICC 8th Edition)
- Male or non pregnant female
- Age is between 18 years and 65 years,
- Eastern Cooperative Oncology Group (ECOG) performance status 0-1 or Karnofsky performance status (KPS) of 70 or more;
- Adequate bone marrow function (White Blood Cells ≥4x109 /L; Neutrophil ≥1.5×109 /L; Hemoglobin≥ 90 g/L; platelets≥100x109 /L);
- Adequate liver function (Total bilirubin, Aspartate transaminase(AST) and Alanine transaminase (ALT) ≤2x Upper Level of Normal (ULN));
- Adequate renal function (serum creatinine (SCr) ≤1.5 x ULN);
- The patient has provided written informed consent and is able to understand and comply with the study.
You may not qualify if…
- Patients with non-squamous cell carcinoma histology;
- Patients with advanced inoperable or metastatic esophageal cancer;
- Patients with another previous or current malignant disease；
- Any patient with a significant medical condition which is thought unlikely to tolerate the therapies. Such as cardiac disease;
- Age >65 years;
- Pregnant or lactating female or people during the birth-period who refused to take contraceptives;
- Uncontrolled seizures or psychiatric diseases, loss of control over their own behavior;
- Patients who refuse surgery after neoadjuvant chemotherapy;
- Unsuitable to be enrolled in the trial in the opinion of the investigators
Where it is running
- Fujian Medical University Union Hospital — Fuzhou, Fujian, China (enrolling)
Full record on ClinicalTrials.gov
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