Status:
UNKNOWN
SIB in Upper Thoracic Esophageal Squamous Cell Carcinoma
Lead Sponsor:
Fudan University
Conditions:
Esophageal Squamous Cell Carcinoma
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief Summary
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.
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
January 1 2017
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2021
Estimated Enrollment :
65 Patients enrolled
Trial Details
Trial ID
NCT04115618
Start Date
January 1 2017
End Date
December 1 2021
Last Update
October 4 2019
Active Locations (1)
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1
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, China