Phase III Study of Concurrent Radiotherapy in Elderly Patients With Esophageal Squamous Cell Carcinoma (ESO-Shanghai 15)
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age76+
SponsorFudan University
About this trial
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.
Eligibility criteria
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- Paclitaxel plus carboplatin
- radiotherapy
Treatment groups
320 Participants
are divided into 2 treatment groupsSponsors and collaborators
Fudan University
Lead sponsor
Huadong Hospital
Collaborator
Jiangsu Cancer Institute & Hospital
Collaborator
Gansu Cancer Hospital
Collaborator
The First Affiliated Hospital of Xiamen University
Collaborator
Fujian Cancer Hospital
Collaborator
Taihe Hospital
Collaborator
Wuxi No. 4 People's Hospital
Collaborator
Ningbo No.2 Hospital
Collaborator
Source ClinicalTrials.gov