Recruitment

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