Phase II Study of Extensive Clinical Target Volumes in Postoperative Radiotherapy for Esophageal Squamous Cell Carcinoma
This trial is active, not recruiting.
|Condition||esophageal squamous cell carcinoma|
|Start date||December 2014|
|End date||December 2017|
|Trial size||74 participants|
|Trial identifier||NCT02384811, 2014-86-882|
The primary object of this trial is to evaluate the 2-year local control rate adding extensive clinical target volumes in postoperative radiotherapy for esophageal squamous cell carcinoma.
|United States||No locations recruiting|
|Other countries||No locations recruiting|
|Intervention model||single group assignment|
Local control rate
time frame: 2 years
time frame: 5 year
Safety: Frequencies of treatment-related adverse event categories by NCI-CTC
time frame: 3 months
Male or female participants from 18 years up to 75 years old.
Inclusion Criteria: - Joined the study voluntarily and signed informed consent form; - Age 18-75；ECOG 0-2 - Esophageal squamous cell carcinoma , radical surgery ≤3 months,R0 resection. The operative incision healed well. - T3-4N0M0, T1-4N1-3M0 (according to AJCC2009) - No radiotherapy, chemotherapy or other treatments pre(post)surgery - 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 after surgery, Esophageal perforation, Haematemesis - 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 - Unsuitable to be enrolled in the trial in the opinion of the investigators
|Official title||Phase II Study of Extensive Clinical Target Volumes in Postoperative Radiotherapy for Esophageal|
|Principal investigator||Jia-qing Xiang, M.M|
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