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

Esophageal Squamous Cell Carcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03790553
• Other study ID #: ESO-Shanghai 12
• Status: Recruiting
• Phase: Phase 3
• Start date: October 15, 2018
• Est. completion date: October 15, 2025

Study information

• Verified date: August 2023
• Source: Fudan University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 646
• Est. completion date: October 15, 2025
• Est. primary completion date: October 15, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Carcinoma
• Esophageal Neoplasms
• Esophageal Squamous Cell Carcinoma

Intervention

Radiation:
• Radiotherapy
Different total radiotherapy dose between two arms.

Locations

Country	Name	City	State
China	Jiangsu Cancer Hospital	Nanjing	Jiangsu
China	Fudan Universtiy Shanghai Cancer Center	Shanghai	Shanghai
China	Huadong Hospital	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Fudan University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	2 years
Primary	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.	2 years
Secondary	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)	2 years
Secondary	Progression-free survival	(defined as the time between Day 1 and the first event of local failure, metastatic recurrence, progression or death)	2 years
Secondary	Overall survival in PET/CT responders	Overall survival in patients who have SUV = 4 in PET/CT analysis in 25-28 radiotherapy fractions.	2 years
Secondary	Questionnaire EORTC-QLQ-C30	A quality of life score is obtained according to the answers to the questionnaires.	2 years
Secondary	Questionnaire EORTC-QLQ-OES18	A quality of life score is obtained according to the answers to the questionnaires.	2 years