Esophageal Squamous Cell Carcinoma
Conditions
Keywords
Esophageal squamous cell carcinoma, postoperative radiotherapy
Brief summary
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.
Interventions
RADIATIONradiation
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.
Sponsors
Fudan University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Local control rate | 2 years |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall survival | 5 year | — |
| Safety: Frequencies of treatment-related adverse event categories by NCI-CTC | 3 months | Frequencies of treatment-related adverse event categories by NCI-CTC including Esophagitis,Pneumonitis/Bronchitis,Skin reaction in radiation fields,Nausea/vomiting,Leucopenia,Thrombocytopenia,Anemia,Fatigue. |
Countries
China
Outcome results
None listed