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Phase II Trial of Thalidomide Combined With Concurrent Chemoradiotherapy in Esophageal Cancer
Conditions
Esophageal Cancer
Conditions: official terms
Esophageal Neoplasms
Conditions: Keywords
Esophageal Cancer, Chemoradiotherapy, VEGF, Thalidomide
Study Type
Interventional
Study Phase
Phase 2
Study Design
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment
Intervention
Name: chemoradiotherapy
Type: Other
Name: thalidomide
Type: Drug
Name: without thalidomide
Type: Other
Overall Status
Recruiting
Summary
The purpose of this study is to down-regulate VEGF expression in esophageal cancer patients by thalidomide, so to improve their chemoradiotherapy effect. Patients with esophageal cancer receiving chemoradiotherapy were divided into different sub-group according to dynamic change of their VEGF level,and those showed increased or unchanged VEGF were added thalidomide at random. Efficacy and side effect of thalidomide combined with chemoradiotherapy were evaluated, and at the same time, activity of thalidomide on esophageal cancer and its clinical safely were assessed.
Detailed Description
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 accelerator.
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.
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.
Criteria for eligibility
Healthy Volunteers: Accepts Healthy Volunteers
Maximum Age: 80 Years
Minimum Age: 20 Years
Gender: Both
Criteria: 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 intolerable
- 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
- 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 intolerable
- 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
Location
Changzhou No.2 People's Hospital
Changzhou City, Jiangsu, China
Status: Recruiting
Contact: Ni Cheng, M.Sc - czerykjk@yahoo.com.cn
Start Date
January 2012
Completion Date
December 2015
Sponsors
Changzhou No.2 People's Hospital
Source
Changzhou No.2 People's Hospital
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page