Treatment options for elderly patients with esophageal squamous cell carcinoma
Phase III Study of Concurrent Radiotherapy in Elderly Patients With Esophageal Squamous Cell Carcinoma (ESO-Shanghai 15)
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 320 (estimated) |
| Ages | 76 Years and up |
| Sex | All |
| Sponsor | Fudan University Academic / other |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 3 sites (Nanjing, Jiangsu and 2 other locations) |
| Trial ID | NCT04519905 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
Not a fit: Patients with severe comorbidities or those who have previously undergone treatment for esophageal cancer may not benefit from this study.
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 performed: 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.
Eligibility criteria
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 this trial is running
Nanjing, Jiangsu and 2 other locations
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.