Status:
RECRUITING
Phase III Study of Concurrent Radiotherapy in Elderly Patients With Esophageal Squamous Cell Carcinoma (ESO-Shanghai 15)
Lead Sponsor:
Fudan University
Collaborating Sponsors:
Huadong Hospital
Jiangsu Cancer Institute & Hospital
Conditions:
Esophageal Squamous Cell Carcinoma
Chemoradiotherapy
Eligibility:
All Genders
76+ years
Phase:
NA
Brief 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 t...
Detailed Description
Up to now, definitive radiotherapy was major treatment plan for elderly ESCC patients. However, whether elective elderly patients can obtain survival benefits through chemoradiotherapy is not clear. T...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 6 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2027
Estimated Enrollment :
320 Patients enrolled
Trial Details
Trial ID
NCT04519905
Start Date
January 6 2020
End Date
December 1 2027
Last Update
November 2 2021
Active Locations (3)
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1
Jiangsu Cancer Hospital
Nanjing, Jiangsu, China
2
Huadong Hospital
Shanghai, Shanghai Municipality, China, 200000
3
Fudan Universtiy Shanghai Cancer Center
Shanghai, Shanghai Municipality, China, 200032