SIB in Upper Thoracic Esophageal Squamous Cell Carcinoma

Fudan University

Status and phase

Unknown

Phase 2

Conditions

Esophageal Squamous Cell Carcinoma

Treatments

Radiation: Simultaneous integrated boost intensity-modulated chemoradiotherapy

Study type

Interventional

Funder types

Other

Identifiers

NCT04115618

2017-ESCCSIB

Details and patient eligibility

About

This study was designed to predict the toxicity and efficacy of Simultaneous Integrated Boost Intensity-modulated Chemoradiotherapy in Upper Thoracic I-IVA Esophageal Squamous Cell Carcinoma.

Enrollment

65 estimated patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Histological or cytologic diagnosis of esophageal squamous carcinoma;
Aged 18-75 years;
KPS ≥ 70;
Upper thoracic esophageal squamous carcinoma: the upper margin of the lesion is located between the entrance of esophagus and the inferior edge of the azygos vein;
Stage I-IVA(AJCC 6th,2009);
Not able to be surgically resection or rejected;
Not have received any prior anticancer therapy;
No serious system dysfunction and immuno-deficiency, Adequate organ function including the following: Hemoglobin ≥9 g/dL, WBC≥4x109/L, Neutrophils (ANC )≥1.5x10^9/L, platelet count ≥100x 10^9/L, serum creatinine<1.5 mg/dL,urea nitrogen <8 mmol/L;
No history of malignancy;
No perforation of esophagus, no deep ulcer of esophagus;
Joined the study voluntarily and signed informed consent form.

Exclusion criteria

Pregnant or breast-feeding women or people during the birth-period who refused to take contraceptives;
Patient who has metastasis such as lung, liver metastasis;
Other malignant tumors;
Uncontrolled seizures or psychiatric diseases, loss of control over their own behavior;
Uncontrollable heart disease, diabetes and hypertension, pulmonary fibrosis, and chest confirmed active pulmonary inflammation require antibiotic treatment, as well as superior vena cava compression syndrome;
After surgery, exploratory thoracotomy, radiotherapy, chemotherapy, or targeting therapy;
Combination of pure red cell anemia or gamma globulin;
Allergic to any medication component studied.