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

NCT01551641 | Unknown Phase 2 DMC

• 1 other identifier: CZEY-THA-001
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 1

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.

Conditions

Esophageal Cancer

Keywords

Esophageal Cancer; Chemoradiotherapy; VEGF; Thalidomide

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (3)

• Overall survival (OS)

  1 year and 3 years after completion of treatment

• Local progression-free survival (LPFS)

  1 year and 3 years after completion of treatment

• Safety

  1 week after completion of treatment

Study Arms (3)

VEGF decressed

EXPERIMENTAL

patients will receive concurrent chemoradiotherapy only

Other: chemoradiotherapy

thalidomide

EXPERIMENTAL

patients will be given thalidomide concurrent chemoradiotherapy

Drug: thalidomide

without thalidomide

EXPERIMENTAL

patients will receive concurrent chemoradiotherapy only

Other: without thalidomide

Interventions

chemoradiotherapy OTHER

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

Also known as: chemo-radiotherapy

VEGF decressed

thalidomide DRUG

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

Also known as: neurosedyn

thalidomide

without thalidomide OTHER

Patients only receive concurrent chemoradiotherapy if their serum VEGF level increase or unchanged

Also known as: without neurosedyn

without thalidomide

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Changzhou No.2 People's Hospital: lead

Study Sites (1)

Changzhou No.2 People's Hospital

Changzhou, Jiangsu, 213003, China

RECRUITING

MeSH Terms

Conditions

Esophageal Neoplasms

Interventions

Chemoradiotherapy; Thalidomide

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases

Intervention Hierarchy (Ancestors)

Combined Modality Therapy; Therapeutics; Drug Therapy; Radiotherapy; Phthalimides; Phthalic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Piperidones; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Isoindoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Sun Suping, M.D.,PhD.

  Changzhou No.2 People's Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sun Suping, M.D.,PhD.

CONTACT

+8651988136082; ssp@126.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Head of Radiation oncology, Principal Investigator, Clinical Professor

Study Record Dates

• First Submitted: February 24, 2012
• First Posted: March 13, 2012
• Study Start: January 1, 2012
• Primary Completion: March 1, 2016
• Study Completion: March 1, 2016
• Last Updated: February 17, 2016

Record last verified: 2016-02

Locations

CN (1)