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

Fudan University

Status and phase

Enrolling

Phase 3

Conditions

Esophageal Squamous Cell Carcinoma

Treatments

Radiation: Radiotherapy

Study type

Interventional

Funder types

Other

Identifiers

NCT03790553

ESO-Shanghai 12

Details and patient eligibility

About

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

Enrollment

646 estimated patients

Sex

All

Ages

18 to 75 years old

Volunteers

No 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.