Phase II Trial of Thalidomide Combined With Concurrent Chemoradiotherapy in Esophageal Cancer
Information source: Changzhou No.2 People's Hospital
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Esophageal Cancer
Intervention: chemoradiotherapy (Other); thalidomide (Drug); without thalidomide (Other)
Phase: Phase 2
Status: Recruiting
Sponsored by: Changzhou No.2 People's Hospital Official(s) and/or principal investigator(s):
Sun Suping, M.D.,PhD., Principal Investigator, Affiliation: Changzhou No.2 People's Hospital
Overall contact:
Sun Suping, M.D.,PhD., Phone: +8651988136082, Email: ssp@126.com
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.
Clinical Details
Official title: A Phase II Clinical Trial on VEGF Expression Interfered by Thalidomide Combined With Concurrent Chemoradiotherapy in Esophageal Cancer
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment
Primary outcome: Treatment efficacy
Secondary outcome: Overall survival (OS)Local progression-free survival (LPFS) Safety
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.
Eligibility
Minimum age: 20 Years.
Maximum age: 80 Years.
Gender(s): 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
Locations and Contacts
Sun Suping, M.D.,PhD., Phone: +8651988136082, Email: ssp@126.com
Changzhou No.2 People's Hospital, Changzhou City, Jiangsu 213003, China; Recruiting
Ni Cheng, M.Sc, Email: czerykjk@yahoo.com.cn
Additional Information
Starting date: January 2012
Last updated: March 12, 2012
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