RecruitingNot ApplicableNCT04519905

Phase III Study of Concurrent Radiotherapy in Elderly Patients With Esophageal Squamous Cell Carcinoma (ESO-Shanghai 15)


Sponsor

Fudan University

Enrollment

320 participants

Start Date

Jan 6, 2020

Study Type

INTERVENTIONAL

Conditions

Summary

So far, there is no specific clinical guideline for elderly patients (\>75 yr) with esophageal squamous cell carcinoma (ESCC). Patients with locally advanced ESCC were enrolled and randomly assigned to either definitive radiotherapy group (61.2Gy/34Fx) or the chemoradiotherapy group (50.4Gy/28Fx;Paclitaxel plus carboplatin). The primary end point was 3-year overall survival (OS). The second end points included life quality, radiation side effects and 3-yr cancer specific survival.


Eligibility

Min Age: 76 Years

Plain Language Summary

Simplified for easier understanding

This study is comparing different radiation therapy approaches — with or without chemotherapy — in elderly patients (76 years and older) with esophageal squamous cell cancer, to find the safest and most effective option for older patients who may not tolerate aggressive treatment as well. **You may be eligible if...** - You are at least 76 years old - You have been diagnosed with esophageal squamous cell carcinoma confirmed by biopsy - You have not previously received radiation, chemotherapy, or surgery for this cancer - You are not a candidate for or have chosen not to pursue surgery **You may NOT be eligible if...** - Your cancer has spread to distant organs - You have previously received treatment for this cancer - You have significant other medical conditions that would make radiation unsafe 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

DRUGPaclitaxel plus carboplatin

Paclitaxel (45mg/m2) plus carboplatin (AUC=2); five cycles; qw

RADIATIONradiotherapy

Different radiotherapy dose in different groups.


Locations(3)

Jiangsu Cancer Hospital

Nanjing, Jiangsu, China

Huadong Hospital

Shanghai, Shanghai Municipality, China

Fudan Universtiy Shanghai Cancer Center

Shanghai, Shanghai Municipality, China

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NCT04519905


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