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

February 14, 2016 updated by: Suping Sun, Changzhou No.2 People's Hospital

A Phase II Clinical Trial on VEGF Expression Interfered by Thalidomide Combined With Concurrent Chemoradiotherapy in Esophageal Cancer

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

180

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Sun Suping, M.D.,PhD.
  • Phone Number: +8651988136082
  • Email: ssp@126.com

Study Locations

  • China
    • Jiangsu
      • Changzhou City, Jiangsu, China, 213003

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 78 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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 Names:
  • 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 Names:
  • 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 Names:
  • without neurosedyn

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
3 months after completion of treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
1 year and 3 years after completion of treatment
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.
1 year and 3 years after completion of treatment
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).
1 week after completion of treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Changzhou No.2 People's Hospital

Investigators

  • Principal Investigator: Sun Suping, M.D.,PhD., Changzhou No.2 People's Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2012

Primary Completion (Anticipated)

March 1, 2016

Study Completion (Anticipated)

March 1, 2016

Study Registration Dates

First Submitted

February 24, 2012

First Submitted That Met QC Criteria

March 12, 2012

First Posted (Estimate)

March 13, 2012

Study Record Updates

Last Update Posted (Estimate)

February 17, 2016

Last Update Submitted That Met QC Criteria

February 14, 2016

Last Verified

February 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CZEY-THA-001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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