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

Fudan University3 sites in 1 country646 target enrollmentOctober 15, 2018

ConditionsEsophageal Squamous Cell Carcinoma

Overview

Phase: Phase 3
Intervention: Not specified
Conditions: Esophageal Squamous Cell Carcinoma
Sponsor: Fudan University
Enrollment: 646
Locations: 3
Primary Endpoint: Overall survival in PET/CT non-responders
Status: Recruiting
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

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

Registry

clinicaltrials.gov

Start Date

October 15, 2018

End Date

October 15, 2025

Last Updated

2 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Fudan University

Responsible Party

Principal Investigator

Kuai Le Zhao, MD

Professor

Fudan University

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.
•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
•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.