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Phase II Trial of Thalidomide Combined With Concurrent Chemoradiotherapy in Esophageal Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01551641
Recruitment Status : Unknown
Verified February 2016 by Suping Sun, Changzhou No.2 People's Hospital.
Recruitment status was:  Recruiting
First Posted : March 13, 2012
Last Update Posted : February 17, 2016
Information provided by (Responsible Party):
Suping Sun, Changzhou No.2 People's Hospital

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.

Condition or disease Intervention/treatment Phase
Esophageal Cancer Other: chemoradiotherapy Drug: thalidomide Other: without thalidomide Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 180 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: A Phase II Clinical Trial on VEGF Expression Interfered by Thalidomide Combined With Concurrent Chemoradiotherapy in Esophageal Cancer
Study Start Date : January 2012
Estimated Primary Completion Date : March 2016
Estimated Study Completion Date : March 2016

Resource links provided by the National Library of Medicine

Drug Information available for: Thalidomide

Arm Intervention/treatment
Experimental: VEGF decressed
patients will receive concurrent chemoradiotherapy only
Other: chemoradiotherapy
Patients only receive concurrent chemoradiotherapy if their serum VEGF level decrease.
Other Name: chemo-radiotherapy

Experimental: thalidomide
patients will be given thalidomide concurrent chemoradiotherapy
Drug: thalidomide
Patients will be given thalidomide combined with concurrent chemoradiotherapy if their serum VEGF level increase or unchanged.
Other Name: neurosedyn

Experimental: without thalidomide
patients will receive concurrent chemoradiotherapy only
Other: without thalidomide
Patients only receive concurrent chemoradiotherapy if their serum VEGF level increase or unchanged
Other Name: without neurosedyn

Primary Outcome Measures :
  1. Treatment efficacy [ Time Frame: 3 months after completion of treatment ]
    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).

Secondary Outcome Measures :
  1. Overall survival (OS) [ Time Frame: 1 year and 3 years after completion of treatment ]
    Overall survival (OS) will be evaluated 1 year and 3 years after completion of treatment using Kaplan-Meier model.

  2. Local progression-free survival (LPFS) [ Time Frame: 1 year and 3 years after completion of treatment ]
    1 year and 3 years after completion of treatment using Kaplan-Meier model.

  3. Safety [ Time Frame: 1 week after completion of treatment ]
    All patients are to be estimated Quality Of Life(such as dizzy, somnolence, queasiness and vomit,anaphylaxis incidence) ,acute radiation reactions such as acute radiation esophagitis and tracheitis incidence(evaluated by the Radiation Therapy Oncology Group (RTOG) toxicity criteria),complete blood cell count(such as leukocyte, neutrophil,hemoglobulin, platelet level), serum biochemistry(such as creatinine level).

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01551641

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Contact: Sun Suping, M.D.,PhD. +8651988136082

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China, Jiangsu
Changzhou No.2 People's Hospital Recruiting
Changzhou City, Jiangsu, China, 213003
Contact: Ni Cheng, M.Sc   
Sponsors and Collaborators
Changzhou No.2 People's Hospital
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Principal Investigator: Sun Suping, M.D.,PhD. Changzhou No.2 People's Hospital

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Responsible Party: Suping Sun, Director, Head of Radiation oncology, Principal Investigator, Clinical Professor, Changzhou No.2 People's Hospital Identifier: NCT01551641    
Other Study ID Numbers: CZEY-THA-001
First Posted: March 13, 2012    Key Record Dates
Last Update Posted: February 17, 2016
Last Verified: February 2016
Keywords provided by Suping Sun, Changzhou No.2 People's Hospital:
Esophageal Cancer
Additional relevant MeSH terms:
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Esophageal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Head and Neck Neoplasms
Digestive System Diseases
Esophageal Diseases
Gastrointestinal Diseases
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Leprostatic Agents
Anti-Bacterial Agents
Anti-Infective Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors
Antineoplastic Agents