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

• Status: Unknown status
• Trial end date: 2016-03-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Changzhou No.2 People's Hospital
• Treatments: Thalidomide

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