A Phase II Clinical Trial on VEGF Expression Interfered by Thalidomide Combined With Concurrent Chemoradiotherapy in Esophageal Cancer
Radiotherapy:Patients will be conducted CT simulation, and three-dimensional conformal
radiation therapy (3DCRT) was performed. 1.8-2.0 Gy/fraction, 5 fractions a week, with a
total dose of 60-72Gy will be delivered for all patients by 6-MV-X-ray of linear
Chemotherapy: Patients will be concurrently administered with irradiation every 4 weeks with
PT regimen (cis-platinum of 25 mg/m2/d, d1-4; PTX(paclitaxel)of 135mg/m2/d, d1) for 4
cycles. For the first 2-cycles of chemotherapy they will be concurrently given with
irradiation and the remained 2 cycles, after irradiation.
Administration of thalidomide: Determine serum VEGF level of the esophageal cancer patients
3-4 weeks after the beginning of radiotherapy, those whose VEGF level, compared with that
before radiotherapy, increased or unchanged will be divided into two groups: one is given
thalidomide concurrent with the following chemoradiotherapy, 100mg/d at bedtime for the
initial week, and if no moderate above side effect occurred 200mg/d from the next week till
the end of chemoradiotherapy; the other received concurrent chemoradiotherapy only.
VEGF determination: Peripheral venous blood samples will be taken in one week before, 3-4
weeks during, and in one week after radiotherapy respectively. The serum VEGF will be
determined by the double antibody sandwich ELISA.
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment
Treatment efficacy were evaluated by the indexes as Locoregional tumor response. Locoregional tumor response will be evaluated 3 months after completion of treatment according to Response Evaluation Criteria in Solid Tumors (RECIST).
3 months after completion of treatment
Sun Suping, M.D.,PhD.
Changzhou No.2 People's Hospital
China: Ministry of Health