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Phase III Study of Concurrent Radiotherapy in Elderly Patients With Esophageal Squamous Cell Carcinoma (ESO-Shanghai 15)

NCT04519905 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 320

Last updated 2021-11-02

No results posted yet for this study

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 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

Interventions

DRUG

Paclitaxel plus carboplatin

Paclitaxel （45mg/m2) plus carboplatin (AUC=2); five cycles; qw

RADIATION

radiotherapy

Different radiotherapy dose in different groups.

Sponsors & Collaborators

  • Huadong Hospital

    collaborator OTHER

  • Jiangsu Cancer Institute & Hospital

    collaborator OTHER

  • Gansu Cancer Hospital

    collaborator OTHER

  • The First Affiliated Hospital of Xiamen University

    collaborator OTHER

  • Fujian Cancer Hospital

    collaborator OTHER_GOV

  • Taihe Hospital

    collaborator OTHER

  • Wuxi No. 4 People's Hospital

    collaborator OTHER

  • Ningbo No.2 Hospital

    collaborator OTHER

  • Fudan University

    lead OTHER

Principal Investigators

  • Kuaile Zhao, doctor · Fudan University

  • Xiangpeng Zheng, doctor · Huadong Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
76 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-01-06
Primary Completion
2024-12-31
Completion
2027-12-31

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04519905 on ClinicalTrials.gov