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

Esophageal Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01551641
• Other study ID #: CZEY-THA-001
• Status: Recruiting
• Phase: Phase 2
• First received: February 24, 2012
• Last updated: February 14, 2016
• Start date: January 2012
• Est. completion date: March 2016

Study information

• Verified date: February 2016
• Source: Changzhou No.2 People's Hospital
• Contact: Sun Suping, M.D.,PhD.
• Phone: +8651988136082
• Email: ssp[@]126.com
• Is FDA regulated: No
• Health authority: China: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 180
• Est. completion date: March 2016
• Est. primary completion date: March 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 20 Years to 80 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Esophageal Cancer
• Esophageal Neoplasms

Intervention

Other:
• chemoradiotherapy
Patients only receive concurrent chemoradiotherapy if their serum VEGF level decrease.

Drug:
• thalidomide
Patients will be given thalidomide combined with concurrent chemoradiotherapy if their serum VEGF level increase or unchanged.

Other:
• without thalidomide
Patients only receive concurrent chemoradiotherapy if their serum VEGF level increase or unchanged

Locations

Country	Name	City	State
China	Changzhou No.2 People's Hospital	Changzhou City	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
Changzhou No.2 People's Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Treatment efficacy	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	Yes
Secondary	Overall survival (OS)	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	Yes
Secondary	Local progression-free survival (LPFS)	1 year and 3 years after completion of treatment using Kaplan-Meier model.	1 year and 3 years after completion of treatment	Yes
Secondary	Safety	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	Yes