RecruitingNot ApplicableNCT03734952

Postoperative Radiotherapy in Thoracic Esophageal Squamous Cell Carcinoma With Neoadjuvant Chemoradiotherapy

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

Sponsor

Fujian Medical University Union Hospital

Enrollment

537 participants

Start Date

May 1, 2023

Study Type

INTERVENTIONAL

Conditions

Radiation Oncology

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

Min Age: 18 YearsMax Age: 65 Years

Plain Language Summary

Simplified for easier understanding

This trial is studying whether adding radiation therapy after surgery for esophageal cancer further reduces the chances of the cancer returning, for patients who already received chemotherapy and radiation before their operation. **You may be eligible if...** - You have squamous cell carcinoma of the esophagus (a specific type of esophageal cancer) located in the chest area - You have not previously received any cancer treatment - Your cancer was Stage II or III before treatment - You are aged 18–65 years - Your overall health is good (ECOG 0–1 or KPS ≥ 70) - You have adequate blood counts and organ function **You may NOT be eligible if...** - You have already received any prior cancer treatment - You are pregnant - Your cancer is located in the neck area (cervical esophagus) - Your cancer is Stage I or Stage IV - Your blood counts or organ function are too low Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

RADIATIONNeoadjuvant Radiotherapy Program:

Gross tumor volume (GTV) should include the primary tumor and involved regional lymph nodes as identified on pre-treatment diagnostic studies. Clinical target volume (CTV) is defined as the primary tumor plus 3cm expansion superiorly and inferiorly along the length of the esophagus and a 1cm radial expansion.The nodal CTV should be defined by a 0.5cm expansion from the nodal GTV.CTV should also include coverage the nodal region(s) in which the involved lymph node(s). A total dose of 45 Gy in 25 fractions is delivered 5 days per week on workdays with intensity modulated radiotherapy (IMRT).

DRUGNeoadjuvant chemotherapy Program

Chemotherapy is delivered concomitantly and composed of two cycles of Docetaxel 60mg per square meter of body-surface area and cisplatin 75mg per square meter of body-surface area every 21 days at the intervals of neoadjuvant radiotherapy.

PROCEDUREEsophagectomy program:

Patients receive esophagectomy in 4-6 weeks after neoadjuvant neoadjuvant chemotherapy

RADIATIONPostoperative radiotherapy program

A total dose of 18 Gy in10 fractions is delivered 5 days per week on workdays with IMRT.

Locations(1)

Fujian Medical University Union Hospital

Fuzhou, Fujian, China

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