This trial is active, not recruiting.

Condition esophageal squamous cell carcinoma
Treatment radiation
Phase phase 2
Sponsor Fudan University
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

Study Design

Intervention model single group assignment
Masking open label
Primary purpose treatment
Radiation therapy
A total dose of 40Gy will be delivered in 20 fractions at 2.0Gy/fraction, 5 fractions per week in 4 weeks. The CTV encompassed the bilateral supraclavicular region, all mediastinal lymph nodes, the anastomosis site, and the left gastric and Celiac nodes.

Primary Outcomes

Local control rate
time frame: 2 years

Secondary Outcomes

Overall survival
time frame: 5 year
Safety: Frequencies of treatment-related adverse event categories by NCI-CTC
time frame: 3 months

Eligibility Criteria

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

Additional Information

Official title Phase II Study of Extensive Clinical Target Volumes in Postoperative Radiotherapy for Esophageal
Principal investigator Jia-qing Xiang, M.M
Trial information was received from ClinicalTrials.gov and was last updated in August 2016.
Information provided to ClinicalTrials.gov by Fudan University.