Cancer statistics in China, 2015.
Wanqing Chen, Rongshou Zheng, Peter D Baade...
https://pubmed.ncbi.nlm.nih.gov/26808342Actively Recruiting
Phase Not Applicable
Age: 18Years - 65Years
All Genders
ID03734952
Prospective Randomized Controlled Trial of Postoperative Radiotherapy in Thoracic Esophageal Squamous Cell Carcinoma With Neoadjuvant Chemoradiotherapy
Led by Fujian Medical University Union Hospital · Updated on 2023-09-25
537
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
The trial investigates the effects of adding postoperative radiotherapy (PORT) to surgery for patients with Stage II or III thoracic esophageal squamous cell carcinoma who have already received neoadjuvant chemoradiotherapy (nCRT). This study aims to compare overall survival time between patients treated with surgery plus PORT and those treated with surgery alone. Recurrence is a major challenge in treating this cancer, and the study evaluates whether PORT can reduce recurrence and improve survival. Patients are randomly assigned to two groups to assess these outcomes with a follow-up of at least 60 months. Participants in Group A receive a combination of neoadjuvant radiotherapy and chemotherapy, followed by esophagectomy surgery and then postoperative radiotherapy using intensity modulated radiotherapy (IMRT) to deliver a total dose of 18 Gy in 10 fractions. Group B receives the same neoadjuvant radiotherapy and chemotherapy plus esophagectomy but without the postoperative radiotherapy. The neoadjuvant radiotherapy involves 45 Gy in 25 fractions delivered 5 days per week, with chemotherapy given as two cycles of Docetaxel and Cisplatin every 21 days. Surgery is performed 4-6 weeks after chemotherapy. During the study, participants undergo assessments for overall survival as the primary outcome, with secondary outcomes including disease-free survival, local recurrence rate, and side effects monitored up to 12 weeks after treatment. The trial includes detailed evaluations of treatment effects over a minimum of five years post-treatment. Participants provide informed consent and are monitored for safety and treatment response throughout the study period.
CONDITIONS
Brief Title
Postoperative Radiotherapy in Thoracic Esophageal Squamous Cell Carcinoma With Neoadjuvant Chemoradiotherapy
Who Can Participate
Age: 18Years - 65Years
All Genders
Eligibility Criteria
You may qualify if you...
- Histologically confirmed squamous cell carcinoma of the esophagus
- Tumor located in the thoracic esophagus
- Pre-treatment stage II or III (AJCC/UICC 8th Edition)
- Male or non-pregnant female
- Age between 18 and 65 years
- ECOG performance status of 0-1 or Karnofsky score of 70 or more
- Adequate bone marrow function (WBC ≥4x10^9/L, Neutrophil ≥1.5x10^9/L, Hemoglobin ≥90 g/L, Platelets ≥100x10^9/L)
- Adequate liver function (bilirubin, AST, ALT ≤2x upper limit of normal)
- Adequate renal function (serum creatinine ≤1.5x upper limit of normal)
- Able to provide informed consent and comply with the study
You will not qualify if you...
- Non-squamous cell carcinoma histology
- Advanced inoperable or metastatic esophageal cancer
- Previous or current other malignant disease
- Significant medical conditions limiting therapy tolerance, such as cardiac disease
- Age over 65 years
- Pregnant or lactating females or those refusing contraception
- Uncontrolled seizures or psychiatric disorders affecting behavior
- Refusal of surgery after neoadjuvant chemotherapy
- Considered unsuitable for enrollment by investigators
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Neoadjuvant Chemoradiotherapy
Duration - Approximately 5 weeks
Participants receive combined neoadjuvant radiotherapy and chemotherapy before surgery.
Radiotherapy 5 days per week for 5 weeks; chemotherapy every 3 weeks for 2 cycles
Surgery
Duration - 1 day (surgery) plus immediate recovery
Participants undergo esophagectomy 4 to 6 weeks after completing neoadjuvant chemoradiotherapy.
1 visit for surgery with immediate post-operative care
Postoperative Radiotherapy (Group A only)
Duration - 2 weeks
Participants assigned to the postoperative radiotherapy group receive additional radiotherapy treatment after surgery.
Radiotherapy 5 days per week for 2 weeks
Follow-up
Duration - Up to 5 years
Participants are monitored for overall survival, disease recurrence, and side effects for up to 5 years after treatment ends.
Regular follow-up visits; frequency varies
Trial Site Locations
Total: 1 location
1
Fujian Medical University Union Hospital
Fuzhou, Fujian, China, 350000
Actively Recruiting
Loading map...
Research Team
B
Benhua Xu, doctor
J
Jianyuan Song, doctor
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here
Published Research Related To This Trial
Effectiveness of esophagectomy in patients with thoracic esophageal squamous cell carcinoma receiving definitive radiotherapy or concurrent chemoradiotherapy through intensity-modulated radiation therapy techniques.
Yu-Chun Yen, Jer-Hwa Chang, Wei-Cheng Lin...
https://pubmed.ncbi.nlm.nih.gov/28152166Is concurrent radiation therapy required in patients receiving preoperative chemotherapy for adenocarcinoma of the oesophagus? A randomised phase II trial.
Bryan H Burmeister, Janine M Thomas, Elizabeth A Burmeister...
https://pubmed.ncbi.nlm.nih.gov/21084184Phase III comparison of preoperative chemotherapy compared with chemoradiotherapy in patients with locally advanced adenocarcinoma of the esophagogastric junction.
Michael Stahl, Martin K Walz, Martin Stuschke...
https://pubmed.ncbi.nlm.nih.gov/19139439Effects of neoadjuvant radiochemotherapy on pathological staging and prognosis for locally advanced esophageal squamous cell carcinoma.
X-F Cao, X-T He, L Ji...
https://pubmed.ncbi.nlm.nih.gov/19703071Neoadjuvant versus adjuvant chemoradiation for stage II-III esophageal squamous cell carcinoma: a single institution experience.
Y Chen, D Hao, X Wu...
https://pubmed.ncbi.nlm.nih.gov/28475725Preoperative chemotherapy versus chemoradiotherapy in locally advanced adenocarcinomas of the oesophagogastric junction (POET): Long-term results of a controlled randomised trial.
Michael Stahl, Martin K Walz, Jorge Riera-Knorrenschild...
https://pubmed.ncbi.nlm.nih.gov/28628843Preoperative chemoradiotherapy for esophageal or junctional cancer.
P van Hagen, M C C M Hulshof, J J B van Lanschot...
https://pubmed.ncbi.nlm.nih.gov/22646630