Endostatin in Combination With Oxaliplatin and Radiotherapy in Esophageal Cancer Patients.

Hangzhou Cancer Hospital

Status and phase: Unknown; Phase 2

Conditions: Endostatin; Esophageal Cancer

Treatments: Drug: Oxaliplatin; Radiation: Radiotherapy; Drug: Endostatins

Study type: Interventional

Funder types: Other

Identifiers

NCT02745561

HangzhouCH05

Details and patient eligibility

About

Endostatin inhibits the pro-angiogenic action of basic fibroblast growth factor and vascular endothelial growth factor in esophageal cancer.This study aims at assessing the efficacy and safety of endostatin combined with concurrent chemoradiotherapy with Oxaliplatin in esophageal cancer patients.

Enrollment: 22 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Cytologically or histologically confirmed esophageal carcinoma
2. Age of 18 -80
3. ECOG performance status: 0-1;
4. No treatments prior to enrollment;
5. At least one measurable lesion on CT, MRI or esophageal barium exam;
6. 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
7. Informed consent signed

Exclusion criteria

1. Prior treatments of chemotherapy or irradiation;
2. Poor bone marrow, liver and kidney functions, which would make chemotherapy intolerable;
3. Contraindication for irradiation: complete obstruction of esophagus, deep esophageal ulcer, fistula to mediastinum, or haematemesis;
4. Participating in other clinical trials;
5. Pregnancy, breast feeding, or not adopting birth control;
6. Clinically significant and uncontrolled major medical conditions including but not limited to: active uncontrolled infection, symptomatic congestive heart failure, Unstable angina pectoris or cardiac arrhythmia, psychiatric illness/ social situation that would limit compliance with study requirements; any medical condition, which in the opinion of the study investigator places the subject at an unacceptably high risk for toxicities
7. The subject has had another active malignancy within the past five years except for cervical cancer in site, in situ carcinoma of the bladder or non-melanoma carcinoma of the skin;

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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22 participants in 1 patient group

Chemoradiotherapy Arm

Experimental group

Description:

Radiotherapy will be delivered with a daily fraction of 2.0 Gy to a total dose of 60 Gy over 6 weeks. Endostatin will be administered at a dose of 7.5 mg/m2/day concurrent with radiotherapy. Oxaliplatin (135mg/m², d1) will be administered on Day 1 and Day 29 of radiotherapy.

Treatment:

Radiation: Radiotherapy

Drug: Endostatins

Drug: Oxaliplatin