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 type | Interventional |
|---|---|
| Ages | 76 Years and up |
| Sex | All |
| Enrollment | 320 (estimated) |
| Sponsor | Fudan University Academic / other |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 3 sites (Nanjing, Jiangsu and 2 other locations) |
| Status | Recruiting |
| Started | January 6, 2020 |
| Main results expected | December 2024 |
| Study ends | December 2027 |
| Registry record updated | November 2, 2021 |
| Trial ID | NCT04519905 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
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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.
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Surufatinib with chemo-immunotherapy and chemoradiotherapy for unresectable locally advanced esophageal squamous cell carcinoma
This trial will test whether adding surufatinib to two cycles of chemo-immunotherapy followed by concurrent chemoradiotherapy helps people with unresectable, locally advanced esophageal squamous cell carcinoma.
-
Combining immunonutrition with chemoradiotherapy for inoperable esophageal cancer
This study is testing whether a special nutritional formula can help people with inoperable esophageal cancer live longer and feel better when combined with chemoradiotherapy.
-
Radiotherapy target-volume choices in locally advanced esophageal cancer during immunotherapy
This observational study looks at how doctors outline the radiation area for locally advanced esophageal squamous cell cancer patients treated with radiotherapy and immunotherapy to see which approaches correlate with better outcomes.
-
Sacituzumab Govitecan plus Tislelizumab for advanced esophageal cancer
This phase II study tests whether the cancer-fighting drug sacituzumab tirumotecan (SKB264) combined with tislelizumab can help adults with advanced esophageal squamous cell carcinoma that progressed after initial immunotherapy.
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Neoadjuvant therapy with adebrelimab, famitinib, and chemotherapy for resectable ESCC
This study tests a combination of adebrelimab, famitinib, and chemotherapy before surgery in people with resectable locally advanced esophageal squamous cell carcinoma to see if it can lead to a complete tumor disappearance at the time of surgery.
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SKB500 combinations for esophageal squamous cell carcinoma
This study tests SKB500 combined with other drugs to see if it is safe and shows early signs of activity in adults with unresectable or metastatic esophageal squamous cell carcinoma who have limited prior treatment.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.