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

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2012 by Changzhou No.2 People's Hospital
Sponsor:
Information provided by (Responsible Party):
Changzhou No.2 People's Hospital
ClinicalTrials.gov Identifier:
NCT01551641
First received: February 24, 2012
Last updated: March 12, 2012
Last verified: February 2012
  Purpose

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 Intervention Phase
Esophageal Cancer
Other: chemoradiotherapy
Drug: thalidomide
Other: without thalidomide
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
Official Title: A Phase II Clinical Trial on VEGF Expression Interfered by Thalidomide Combined With Concurrent Chemoradiotherapy in Esophageal Cancer

Resource links provided by NLM:


Further study details as provided by Changzhou No.2 People's Hospital:

Primary Outcome Measures:
  • Treatment efficacy [ Time Frame: 3 months after completion of treatment ] [ Designated as safety issue: Yes ]
    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:
  • Overall survival (OS) [ Time Frame: 1 year and 3 years after completion of treatment ] [ Designated as safety issue: Yes ]
    Overall survival (OS) will be evaluated 1 year and 3 years after completion of treatment using Kaplan-Meier model.

  • Local progression-free survival (LPFS) [ Time Frame: 1 year and 3 years after completion of treatment ] [ Designated as safety issue: Yes ]
    1 year and 3 years after completion of treatment using Kaplan-Meier model.

  • Safety [ Time Frame: 1 week after completion of treatment ] [ Designated as safety issue: Yes ]
    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).


Estimated Enrollment: 180
Study Start Date: January 2012
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

Ages Eligible for Study:   20 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01551641

Contacts
Contact: Sun Suping, M.D.,PhD. +8651988136082 ssp@126.com

Locations
China, Jiangsu
Changzhou No.2 People's Hospital Recruiting
Changzhou City, Jiangsu, China, 213003
Contact: Ni Cheng, M.Sc       czerykjk@yahoo.com.cn   
Sponsors and Collaborators
Changzhou No.2 People's Hospital
Investigators
Principal Investigator: Sun Suping, M.D.,PhD. Changzhou No.2 People's Hospital
  More Information

No publications provided

Responsible Party: Changzhou No.2 People's Hospital
ClinicalTrials.gov Identifier: NCT01551641     History of Changes
Other Study ID Numbers: CZEY-THA-001
Study First Received: February 24, 2012
Last Updated: March 12, 2012
Health Authority: China: Ministry of Health

Keywords provided by Changzhou No.2 People's Hospital:
Esophageal Cancer
Chemoradiotherapy
VEGF
Thalidomide

Additional relevant MeSH terms:
Esophageal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Head and Neck Neoplasms
Digestive System Diseases
Esophageal Diseases
Gastrointestinal Diseases
Thalidomide
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Leprostatic Agents
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors
Antineoplastic Agents

ClinicalTrials.gov processed this record on August 20, 2014