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Trial Title:
Phase II Trial of Thalidomide Combined With Concurrent Chemoradiotherapy in Esophageal Cancer
NCT ID:
NCT01551641
Condition:
Esophageal Cancer
Conditions: Official terms:
Esophageal Neoplasms
Thalidomide
Conditions: Keywords:
Esophageal Cancer
Chemoradiotherapy
VEGF
Thalidomide
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Unknown status
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
Single (Investigator)
Intervention:
Intervention type:
Other
Intervention name:
chemoradiotherapy
Description:
Patients only receive concurrent chemoradiotherapy if their serum VEGF level decrease.
Arm group label:
VEGF decressed
Other name:
chemo-radiotherapy
Intervention type:
Drug
Intervention name:
thalidomide
Description:
Patients will be given thalidomide combined with concurrent chemoradiotherapy if their
serum VEGF level increase or unchanged.
Arm group label:
thalidomide
Other name:
neurosedyn
Intervention type:
Other
Intervention name:
without thalidomide
Description:
Patients only receive concurrent chemoradiotherapy if their serum VEGF level increase or
unchanged
Arm group label:
without thalidomide
Other name:
without neurosedyn
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.
Criteria for eligibility:
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
Gender:
All
Minimum age:
20 Years
Maximum age:
80 Years
Healthy volunteers:
Accepts Healthy Volunteers
Locations:
Facility:
Name:
Changzhou No.2 People's Hospital
Address:
City:
Changzhou City
Zip:
213003
Country:
China
Status:
Recruiting
Contact:
Last name:
Ni Cheng, M.Sc
Email:
czerykjk@yahoo.com.cn
Start date:
January 2012
Completion date:
March 2016
Lead sponsor:
Agency:
Changzhou No.2 People's Hospital
Agency class:
Other
Source:
Changzhou No.2 People's Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT01551641
