Study of S-1 in Combination With Radiotherapy in Esophageal Cancer
This trial is active, not recruiting.
|Condition||esophageal squamous cell carcinoma|
|Treatments||s-1, radiation therapy|
|Start date||March 2013|
|End date||October 2018|
|Trial size||105 participants|
|Trial identifier||NCT01831531, ESO-Shanghai7|
This trial aims to study the safety, the local control, and the overall survival of S-1 combined with radiotherapy for patients with esophageal squamous cell carcinoma. 105 patients will be recruited into this trial.
|Intervention model||single group assignment|
Number of participants with adverse events
time frame: 1 years
3-yr local control rate
time frame: 3 years
time frame: 3 years
All participants at least 18 years old.
Inclusion Criteria: - Joined the study voluntarily and signed informed consent form; - Age ＞75 or age 18-75 who are intolerant of or reject intravenous chemotherapy - Both genders - Esophageal squamous cell carcinoma confirmed by pathology - Local advanced esophageal squamous cell carcinoma (T2-4N0-1M0-1a,TxN1M0-1a,TxNxM1a, AJCC 6th) - No radiotherapy, chemotherapy or other treatments prior to enrollment - PS ECOG 0-2 - Life expectancy of more than 3 months - Hemoglobin（Hb）≥9 g/dL - WBC≥3x109/L, Neutrophils (ANC )≥1.5x109/L - platelet count (Pt) ≥100x 109/L - Hepatic function: ALAT and ASAT < 2.5 x ULN, TBIL<1.5 x ULN - Renal function: creatinine < 1.5 x ULN - No immuno-deficiency - Use of an effective contraceptive for adults to prevent pregnancy. Exclusion Criteria: - Complete esophageal obstruction - Deep esophageal ulcer - Esophageal perforation - Haematemesis - After surgery, exploratory thoracotomy, radiotherapy, chemotherapy, or targeting therapy - Other malignant tumors, except for skin basal cell carcinoma, or cervical carcinoma in situ, who survived with no evidence disease for over 3 years - Participation in other interventional clinical trials within 30 days - Pregnant or breast-feeding women or people during the birth-period who refused to take contraceptives - Drug addiction - Alcoholism or AIDS - Uncontrolled seizures or psychiatric diseases, loss of control over their own behavior - Patient who has metastasis such as lung, liver metastasis
|Official title||Phase II Study of S-1 in Combination With Radiotherapy in Esophageal Squamous Cell Carcinoma|
|Principal investigator||Kuaile Zhao, M.D.|
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