Esophageal Cancer Clinical Trials

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

Status: Recruiting
Location: See location...
Intervention Type: Procedure, Radiation, Drug
Study Type: Interventional
Study Phase: Not Applicable
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).

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 65
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
China
Fujian Medical University Union Hospital
RECRUITING
Fuzhou
Contact Information
Primary
Benhua Xu, doctor
benhuaxu@163.com
+86-13696884375
Backup
Jianyuan Song, doctor
songjianyuan@163.com
+86-13625045732
Time Frame
Start Date: 2023-05-01
Estimated Completion Date: 2029-01-01
Participants
Target number of participants: 537
Treatments
Experimental: Group A
Neoadjuvant Radiotherapy Program+Neoadjuvant chemotherapy Program+ Esophagectomy program+Postoperative radiotherapy program
Other: Group B
Neoadjuvant Radiotherapy Program+Neoadjuvant chemotherapy Program+ Esophagectomy program
Related Therapeutic Areas
Sponsors
Leads: Fujian Medical University Union Hospital

This content was sourced from clinicaltrials.gov