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

Sponsor

Hangzhou Cancer Hospital (Other)

Overall Status

Unknown status

CT.gov ID

NCT02745561

Collaborator

(none)

Enrollment

Location

Arm

Duration (Months)

0.6

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Esophageal Cancer Endostatin	Drug: Endostatins Drug: Oxaliplatin Radiation: Radiotherapy	Phase 2

Study Design

Study Type:

Interventional

Anticipated Enrollment :

22 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

A Phase II Study of Endostatin in Combination With Oxaliplatin and Radiotherapy in Esophageal Cancer Patients.

Study Start Date :

Jan 1, 2016

Anticipated Primary Completion Date :

Dec 1, 2017

Anticipated Study Completion Date :

Dec 1, 2018

Arms and Interventions

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

Arm

Intervention/Treatment

Experimental: Chemoradiotherapy Arm

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.

Drug: Endostatins

Endostatin will be administered at a dose of 7.5 mg/m2/day concurrent with radiotherapy.

Drug: Oxaliplatin

Oxaliplatin (135mg/m², d1) will be administered on Day 1 and Day 29 of radiotherapy.

Radiation: Radiotherapy

Radiotherapy will be delivered with a daily fraction of 2.0 Gy to a total dose of 60 Gy over 6 weeks.

Outcome Measures

Primary Outcome Measures

response rate [week 3-4]
Response rate will be done after 3-4 weeks following the last radiotherapy session.

Secondary Outcome Measures

Acute and late toxicities assessed based on the common toxicity criteria for adverse events version 3.0 (CTCAEv3.0) [year 0 - year 3]
Acute and late toxicities will be assessed based on the common toxicity criteria for adverse events version 3.0 (CTCAEv3.0).
Progression-free survival [year 0 - year 3]
Progression-free survival (PFS) will be calculated from the date of chemoradiotherapy initiation to the date of documented failure (local recurrence or metastasis occurrence) or the date of the last follow-up for those remaining.
Overall survival [year 0 - year 3]
Overall survival (OS) will be determined as the time (in months) between the first day of therapy and the last follow-up or the date of death.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Cytologically or histologically confirmed esophageal carcinoma
Age of 18 -80
ECOG performance status: 0-1;
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;
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
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;