Actively Recruiting
Phase III Study of Concurrent Radiotherapy in Elderly Patients With Esophageal Squamous Cell Carcinoma (ESO-Shanghai 15)
Led by Fudan University · Updated on 2021-11-02
320
Participants Needed
3
Research Sites
412 weeks
Total Duration
On this page
Sponsors
F
Fudan University
Lead Sponsor
H
Huadong Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Phase III Study of Concurrent Radiotherapy in Elderly Patients With Esophageal Squamous Cell Carcinoma (ESO-Shanghai 15)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participants of any sex
- Age 76 years or older
- Pathologically confirmed esophageal squamous cell carcinoma
- No prior radiotherapy, chemotherapy, or other treatments for esophageal cancer
- Locally advanced esophageal squamous cell carcinoma (T2-4N0-1M0-1a, TxN1M0-1a, TxNxM1a, TxNxM1b [M1b only for supraclavicular lymph node metastasis]) according to AJCC 6th edition
- Use of effective contraception for adults to prevent pregnancy
- No severe abnormality in blood, heart, lung, kidney, or liver function
- No immunodeficiency
- ECOG performance status 0-1
- Life expectancy greater than 3 months
You will not qualify if you...
- Total radiotherapy dose cannot reach 61.2 Gy in 34 fractions
- Presence of esophageal perforation or hematemesis
- History of radiotherapy or chemotherapy for esophageal cancer
- Surgery within 28 days before Day 1 of the study
- History of prior malignancies except skin basal cell carcinoma or cervical carcinoma in situ with at least 3 years disease-free
- Participation in other interventional clinical trials within 30 days
- Pregnant or breastfeeding women or fertile patients
- Drug addiction, alcoholism, or AIDS
- Uncontrolled seizures or psychiatric disorders
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 3 locations
1
Jiangsu Cancer Hospital
Nanjing, Jiangsu, China
Actively Recruiting
2
Huadong Hospital
Shanghai, Shanghai Municipality, China, 200000
Actively Recruiting
3
Fudan Universtiy Shanghai Cancer Center
Shanghai, Shanghai Municipality, China, 200032
Actively Recruiting
Research Team
K
Kuaile Zhao, doctor
CONTACT
Y
ying jia Deng, doctor
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here