Clinical trial Recruiting at 3 sites Interventional Ages 76 and up

Treatment options for elderly patients with esophageal squamous cell carcinoma

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

Run by Fudan University · NCT04519905 · Data updated 2026-11-12

This study is testing whether combining chemotherapy with radiation helps older patients over 75 with advanced esophageal cancer live longer and feel better compared to just radiation alone.

Quick facts

Study typeInterventional
Ages76 Years and up
SexAll
Enrollment320 (estimated)
SponsorFudan University
Academic / other
Drugs / interventionschemotherapy, radiation
Locations3 sites (Nanjing, Jiangsu and 2 other locations)
StatusRecruiting
StartedJanuary 6, 2020
Main results expectedDecember 2024
Study endsDecember 2027
Registry record updatedNovember 2, 2021
Trial IDNCT04519905 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates are elderly patients aged 76 years and older with locally advanced esophageal squamous cell carcinoma who have not received prior treatments.

Probably not a fit

Patients with severe comorbidities or those who have previously undergone treatment for esophageal cancer may not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial investigates the effectiveness of concurrent radiotherapy versus chemoradiotherapy in elderly patients aged over 75 with locally advanced esophageal squamous cell carcinoma (ESCC). A total of 320 patients will be randomly assigned to receive either definitive radiotherapy or a combination of paclitaxel and carboplatin along with radiotherapy. The primary goal is to evaluate the 3-year overall survival rate, while secondary outcomes include quality of life assessments and cancer-specific survival rates. The study aims to clarify the potential survival benefits of chemoradiotherapy in this patient population.

Why it matters

Potential benefit: If successful, this study could provide new treatment options that improve survival rates for elderly patients with esophageal squamous cell carcinoma.

How similar studies have gone: While there is limited specific guidance for this age group, similar studies have shown promising results in younger populations, indicating potential for success in this novel approach.

Who can join: the full rules

Show full inclusion / exclusion criteria
Inclusion Criteria:

* Indicates no limit on eligibility based on the sex of participants
* The 76 years old for the minimum age a potential participant must meet to be eligible for the clinical study.
* Esophageal squamous cell carcinoma confirmed by pathology
* No radiotherapy, chemotherapy or other treatments prior to enrollment
* Local advanced esophageal squamous cell carcinoma (T2-4N0-1M0-1a, TxN1M0-1a, TxNxM1a, TxNxM1b (M1b only for supraclavicular lymph node metastasis) (AJCC 6th)
* Use of an effective contraceptive for adults to prevent pregnancy
* No severely abnormal hematopoietic, cardiac, pulmonary, renal, or hepatic function
* No immunodeficiency
* ECOG 0-1.
* Life expectancy of more than 3 months.

Exclusion Criteria:

* Total radiotherapy dose cannot reach 61.2Gy/34Fx
* Esophageal perforation, or hematemesis
* History of radiotherapy or chemotherapy for esophageal cancer
* History of surgery within 28 days before Day 1
* History of prior malignancies (other than skin basal cell carcinoma or cervical carcinoma in situ with a disease-free survival of at least 3 years)
* Participation in other interventional clinical trials within 30 days
* Pregnant or breast-feeding women or fertile patients
* Drug addiction,
* alcoholism or AIDS
* Uncontrolled seizures or psychiatric disorders

Where it's running

  • Jiangsu Cancer Hospital
    Nanjing, Jiangsu, China
    Recruiting
  • Huadong Hospital
    Shanghai, Shanghai Municipality, China
    Recruiting
  • Fudan Universtiy Shanghai Cancer Center
    Shanghai, Shanghai Municipality, China
    Recruiting

Study contacts

  • Principal investigator: Xiangpeng Zheng, doctor — Huadong Hospital
  • Study coordinator: Kuaile Zhao, doctor
  • Email: kuaile_z@sina.com
  • Phone: 18017312534

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.