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A Phase II Clinical Trial on VEGF Expression Interfered by Thalidomide Combined With Concurrent Chemoradiotherapy in Esophageal Cancer

Phase 2
20 Years
80 Years
Open (Enrolling)
Esophageal Cancer

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Trial Information

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.

Inclusion Criteria:

- cytologically or histologically confirmed esophageal carcinoma

- age of 20 -80

- Karnofsky performance status ≥ 70

- no treatments prior to enrollment

- at least one measurable lesion on CT, MRI or esophageal barium exam

- normal functions of heart, lung, liver, kidney and bone marrow

- blood exams qualified for chemotherapy, which included hemoglobulin ≥9 g/dl,
neutrophil ≥1.5×109/L and platelet (PLT) ≥100×109/L, creatinine ≤1.5 UNL

- informed consent signed

Exclusion Criteria:

- prior treatments of chemotherapy or irradiation

- poor bone marrow, liver and kidney functions, which would make chemotherapy

- contraindication for irradiation: complete obstruction of esophagus, deep esophageal
ulcer, fistula to mediastinum, or haematemesis

- participating in other clinical trials

- pregnancy, breast feeding, or not adopting birth control

- drug or alcohol addiction, uncontrolled epileptic seizure, or psychotic with no
ability of self control

- coexisted morbidities that investigators believed not suitable for chemoradiation

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Outcome Measure:

Treatment efficacy

Outcome Description:

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).

Outcome Time Frame:

3 months after completion of treatment

Safety Issue:


Principal Investigator

Sun Suping, M.D.,PhD.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Changzhou No.2 People's Hospital


China: Ministry of Health

Study ID:




Start Date:

January 2012

Completion Date:

December 2015

Related Keywords:

  • Esophageal Cancer
  • Esophageal Cancer
  • Chemoradiotherapy
  • VEGF
  • Thalidomide
  • Esophageal Diseases
  • Esophageal Neoplasms