Clinical trial NCT01551641: Phase II Trial of Thalidomide Combined With Concurrent Chemoradiotherapy in Esophageal Cancer
Official title: A Phase II Clinical Trial on VEGF Expression Interfered by Thalidomide Combined With Concurrent Chemoradiotherapy in Esophageal Cancer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Esophageal Cancer
Keywords: Esophageal Cancer
Chemoradiotherapy
VEGF
Thalidomide
Lead sponsor: Changzhou No.2 People's Hospital
Sponsor class: OTHER
First posted: 2012-03-13
Enrollment: 180
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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

Primary outcomes:
measure: Treatment efficacy
timeFrame: 3 months after completion of treatment
Secondary outcomes:
measure: Overall survival (OS)
timeFrame: 1 year and 3 years after completion of treatment
measure: Local progression-free survival (LPFS)
timeFrame: 1 year and 3 years after completion of treatment
measure: Safety
timeFrame: 1 week after completion of treatment
Other outcomes:
Locations:
city: Changzhou City
country: China
facility: Changzhou No.2 People's Hospital
state: Jiangsu
Study officials:
affiliation: Changzhou No.2 People's Hospital
name: Sun Suping, M.D.,PhD.
role: PRINCIPAL_INVESTIGATOR
References: