Phase III Study of Concurrent Radiotherapy in Elderly Patients With Esophageal Squamous Cell Carcinoma (ESO-Shanghai 15)
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Chemoradiotherapy
- Esophageal Squamous Cell Carcinoma
- Survival
- Type
- Interventional
- Phase
- Not Applicable
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentMasking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 76 years and 125 years
- Gender
- Both males and females
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. Thus we design the clinical trail to answer the question. Three hundred and twenty elderly patients w...
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. Thus we design the clinical trail to answer the question. Three hundred and twenty elderly patients with ESCC would be recruited. There are two stratification factors including 80 years old and lymph node metastasis. The patients in the chemoradiotherapy group were treated with paclitaxel (45mg/m2) and carboplatin (AUC=2) one cycle per week for five cycles.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. The life quality questionnaire included QlQ-C30 and OES-18.
Tracking Information
- NCT #
- NCT04519905
- Collaborators
- Huadong Hospital
- Jiangsu Cancer Institute & Hospital
- Gansu Cancer Hospital
- The First Affiliated Hospital of Xiamen University
- Fujian Cancer Hospital
- Taihe Hospital
- Wuxi No. 4 People's Hospital
- Ningbo No.2 Hospital
- Investigators
- Study Chair: Kuaile Zhao, doctor Fudan University Principal Investigator: Xiangpeng Zheng, doctor Huadong Hospital