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

Primary Purpose

Esophageal Squamous Cell Carcinoma

Status
Recruiting
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
Radiotherapy
Sponsored by
Fudan University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Esophageal Squamous Cell Carcinoma focused on measuring chemoradiotherapy, esophageal cancer, PET/CT

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Jiangsu Cancer HospitalRecruiting
  • Huadong HospitalRecruiting
  • Fudan Universtiy Shanghai Cancer CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

50.4Gy

61.2Gy

Arm Description

Total radiotherapy dose of 50.4Gy.

Total radiotherapy dose of 61.2Gy.

Outcomes

Primary Outcome Measures

Overall survival in PET/CT non-responders
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.
Overall survival in ITT population
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.

Secondary Outcome Measures

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

Full Information

First Posted
October 17, 2018
Last Updated
August 1, 2023
Sponsor
Fudan University
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1. Study Identification

Unique Protocol Identification Number
NCT03790553
Brief Title
Comparing 61.2 Gy Radiotherapy Dose Versus 50.4 Gy Radiotherapy Dose for Locally Advanced Esophageal Carcinoma
Official Title
A Phase III Study of Comparing 61.2 Gy Radiotherapy Dose Versus 50.4 Gy Radiotherapy Dose for Locally Advanced Esophageal Carcinoma
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 15, 2018 (Actual)
Primary Completion Date
October 15, 2023 (Anticipated)
Study Completion Date
October 15, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Fudan University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Esophageal Squamous Cell Carcinoma
Keywords
chemoradiotherapy, esophageal cancer, PET/CT

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
646 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
50.4Gy
Arm Type
Active Comparator
Arm Description
Total radiotherapy dose of 50.4Gy.
Arm Title
61.2Gy
Arm Type
Experimental
Arm Description
Total radiotherapy dose of 61.2Gy.
Intervention Type
Radiation
Intervention Name(s)
Radiotherapy
Intervention Description
Different total radiotherapy dose between two arms.
Primary Outcome Measure Information:
Title
Overall survival in PET/CT non-responders
Description
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.
Time Frame
2 years
Title
Overall survival in ITT population
Description
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.
Time Frame
2 years
Secondary Outcome Measure Information:
Title
Local control rate
Description
The time between the start of the study treatment (Day 1) and local reccurence (included the primary tumor and regional lymph node failure)
Time Frame
2 years
Title
Progression-free survival
Description
(defined as the time between Day 1 and the first event of local failure, metastatic recurrence, progression or death)
Time Frame
2 years
Title
Overall survival in PET/CT responders
Description
Overall survival in patients who have SUV ≤ 4 in PET/CT analysis in 25-28 radiotherapy fractions.
Time Frame
2 years
Title
Questionnaire EORTC-QLQ-C30
Description
A quality of life score is obtained according to the answers to the questionnaires.
Time Frame
2 years
Title
Questionnaire EORTC-QLQ-OES18
Description
A quality of life score is obtained according to the answers to the questionnaires.
Time Frame
2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Jiangsu Cancer Hospital
City
Nanjing
State/Province
Jiangsu
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jinjun C Ye, M.D.
Phone
13585175433
Ext
13585175433
Email
jjye2004@163.com
First Name & Middle Initial & Last Name & Degree
Jinjun C Ye, M.D.
Facility Name
Huadong Hospital
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xiangpeng Zheng, M.D.
Phone
8621-62483180
Ext
862162483180
Email
zhengxp@fudan.edu.cn
First Name & Middle Initial & Last Name & Degree
Xiangpeng Zheng
Phone
862162483180
Ext
862162483180
Email
zhengxp@fudan.edu.cn
First Name & Middle Initial & Last Name & Degree
Xiangpeng Zheng
Facility Name
Fudan Universtiy Shanghai Cancer Center
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200032
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kuaile Zhao, MD.
Phone
+8618017312534
Email
kuaile_z@sina.com

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
35906623
Citation
Zhu H, Liu Q, Xu H, Mo M, Wang Z, Lu K, Zhou J, Chen J, Zheng X, Ye J, Ge X, Luo H, Liu Q, Deng J, Ai D, Hao S, Zhang J, Tseng IH, Song S, Chen Y, Zhao K. Dose escalation based on 18F-FDG PET/CT response in definitive chemoradiotherapy of locally advanced esophageal squamous cell carcinoma: a phase III, open-label, randomized, controlled trial (ESO-Shanghai 12). Radiat Oncol. 2022 Jul 29;17(1):134. doi: 10.1186/s13014-022-02099-y.
Results Reference
derived

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

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