Comparing 61.2 Gy Radiotherapy Dose Versus 50.4 Gy Radiotherapy Dose for Locally Advanced Esophageal Carcinoma

August 1, 2023 updated by: Kuai Le Zhao, MD, Fudan University

A Phase III Study of Comparing 61.2 Gy Radiotherapy Dose Versus 50.4 Gy Radiotherapy Dose for Locally Advanced Esophageal Carcinoma

The purpose of this study is to determined the best definitive radiotherapy dosage for patients with locally advanced esophageal squamous cell carcinoma.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

646

Phase

  • Phase 3

Contacts and Locations

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

Study Locations

  • China
    • Jiangsu
      • Nanjing, Jiangsu, China
        • Recruiting
        • Jiangsu Cancer Hospital
        • Contact:
          • Jinjun C Ye, M.D.
          • Phone Number: 13585175433 13585175433
          • Email: jjye2004@163.com
        • Principal Investigator:
          • Jinjun C Ye, M.D.
    • Shanghai
      • Shanghai, Shanghai, China, 200000
        • Recruiting
        • Huadong Hospital
        • Contact:
        • Contact:
        • Principal Investigator:
          • Xiangpeng Zheng
      • 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

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Joined the study voluntarily and signed informed consent form;
  • Age 18-75 years; both genders
  • Esophageal squamous cell carcinoma confirmed by pathology.
  • No radiotherapy, chemotherapy or other treatments prior to enrollment
  • Locally advanced esophageal squamous cell carcinoma (T1N1-3M0, T2-4NxM0, TxNxM1 (supraclavicular lymph node metastasis only) (AJCC 8th)
  • Use of an effective contraceptive for adults to prevent pregnancy.
  • No severely abnormal hematopoietic, cardiac, pulmonary, renal, or hepatic function. No immunodeficiency.
  • WBC ≥ 3.5*109/L, Hemoglobin ≥ 9 g/dL, Neutrophils ≥ 1·5*109/L, Platelet count ≥ 100*109/L, ALAT and ASAT < 2·5 * ULN, TBIL < 1·5 * ULN, and Creatinine < 1·5 *ULN.
  • ECOG 0-2.
  • Life expectancy of more than 3 months.
  • Agreement of PET/CT accessment at 25-28 radiotherapy fraction.

Exclusion Criteria:

  • Total radiotherapy dose cannot reach 61.2Gy/34Fx in the condition of the nomal tissue dose complying to the standard criteria.
  • 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 who refused to use contraceptives.
  • Drug addiction, alcoholism or AIDS.
  • Uncontrolled seizures or psychiatric disorders.
  • Any other condition which in the investigator's opinion would not make the patient a good candidate for the clinical trial.

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
Active Comparator: 50.4Gy
Total radiotherapy dose of 50.4Gy.
Radiation: Radiotherapy
Different total radiotherapy dose between two arms.
Experimental: 61.2Gy
Total radiotherapy dose of 61.2Gy.
Radiation: Radiotherapy
Different total radiotherapy dose between two arms.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall survival in PET/CT non-responders
Time Frame: 2 years
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.
2 years
Overall survival in ITT population
Time Frame: 2 years
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.
2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Local control rate
Time Frame: 2 years
The time between the start of the study treatment (Day 1) and local reccurence (included the primary tumor and regional lymph node failure)
2 years
Progression-free survival
Time Frame: 2 years
(defined as the time between Day 1 and the first event of local failure, metastatic recurrence, progression or death)
2 years
Overall survival in PET/CT responders
Time Frame: 2 years
Overall survival in patients who have SUV ≤ 4 in PET/CT analysis in 25-28 radiotherapy fractions.
2 years
Questionnaire EORTC-QLQ-C30
Time Frame: 2 years
A quality of life score is obtained according to the answers to the questionnaires.
2 years
Questionnaire EORTC-QLQ-OES18
Time Frame: 2 years
A quality of life score is obtained according to the answers to the questionnaires.
2 years

Collaborators and Investigators

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

Sponsor

Fudan University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

October 15, 2018

Primary Completion (Estimated)

October 15, 2023

Study Completion (Estimated)

October 15, 2025

Study Registration Dates

First Submitted

October 17, 2018

First Submitted That Met QC Criteria

December 28, 2018

First Posted (Actual)

December 31, 2018

Study Record Updates

Last Update Posted (Actual)

August 3, 2023

Last Update Submitted That Met QC Criteria

August 1, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ESO-Shanghai 12

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

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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