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

October 31, 2021 updated by: Fudan University
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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. 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.

Study Type

Interventional

Enrollment (Anticipated)

320

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Kuaile Zhao, doctor
  • Phone Number: 021-64175590 18017312534
  • Email: kuaile_z@sina.com

Study Contact Backup

Study Locations

  • China
    • Jiangsu
      • Nanjing, Jiangsu, China
        • Recruiting
        • Jiangsu Cancer Hospital
    • Shanghai
      • Shanghai, Shanghai, China, 200000
        • Recruiting
        • Huadong Hospital
      • Shanghai, Shanghai, China, 200032
        • Recruiting
        • Fudan Universtiy Shanghai Cancer Center
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

76 years and older (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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 Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: chemoradiotherapy
50.4Gy/28Fx; Paclitaxel plus carboplatin
Drug: Paclitaxel plus carboplatin
Paclitaxel （45mg/m2) plus carboplatin (AUC=2); five cycles; qw
Radiation: radiotherapy
Different radiotherapy dose in different groups.
Active Comparator: radiotherapy
61.2Gy/34Fx
Radiation: radiotherapy
Different radiotherapy dose in different groups.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
overall survival difference of definitive radiotherapy and chemoradiotherapy groups
Time Frame: 3-year
The time between the start of the study treatment (Day 1) and death from any cause or last follow-up for patients alive at the end of the study.
3-year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
difference of quality of life between different groups
Time Frame: the period of treatment within 7 weeks and follow up time with an average of 3months
Assess the quality of life through life quality questionnaire.
the period of treatment within 7 weeks and follow up time with an average of 3months
radiation side effects
Time Frame: acute side effects within 3 months, late side effects for 3 months later
Record the radiation side effects including acute and late side effects.
acute side effects within 3 months, late side effects for 3 months later
cancer specific survival
Time Frame: 3-year
The time between the start of the study treatment (Day 1) and death from tumor or last follow-up for patients alive at the end of the study.
3-year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fudan University

Collaborators

Fujian Cancer Hospital
Jiangsu Cancer Institute & Hospital
Ningbo No.2 Hospital
Taihe Hospital
The First Affiliated Hospital of Xiamen University
Huadong Hospital
Gansu Cancer Hospital
Wuxi No. 4 People's Hospital

Investigators

  • Study Chair: Kuaile Zhao, doctor, Fudan University
  • Principal Investigator: Xiangpeng Zheng, doctor, Huadong Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 6, 2020

Primary Completion (Anticipated)

December 1, 2024

Study Completion (Anticipated)

December 1, 2027

Study Registration Dates

First Submitted

August 12, 2020

First Submitted That Met QC Criteria

August 19, 2020

First Posted (Actual)

August 20, 2020

Study Record Updates

Last Update Posted (Actual)

November 2, 2021

Last Update Submitted That Met QC Criteria

October 31, 2021

Last Verified

October 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ESO-Shanghai15

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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