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

Primary Purpose

Esophageal Cancer, Endostatin

Status
Unknown status
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Endostatins
Oxaliplatin
Radiotherapy
Sponsored by
Hangzhou Cancer Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Esophageal Cancer focused on measuring Endostatin, Oxaliplatin, Esophageal Cancer, chemoradiotherapy

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept 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;

Sites / Locations

  • Hangzhou Cancer HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Chemoradiotherapy Arm

Arm 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.

Outcomes

Primary Outcome Measures

response rate
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)
Acute and late toxicities will be assessed based on the common toxicity criteria for adverse events version 3.0 (CTCAEv3.0).
Progression-free survival
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
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.

Full Information

First Posted
April 18, 2016
Last Updated
April 19, 2016
Sponsor
Hangzhou Cancer Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02745561
Brief Title
Endostatin in Combination With Oxaliplatin and Radiotherapy in Esophageal Cancer Patients.
Official Title
A Phase II Study of Endostatin in Combination With Oxaliplatin and Radiotherapy in Esophageal Cancer Patients.
Study Type
Interventional

2. Study Status

Record Verification Date
April 2016
Overall Recruitment Status
Unknown status
Study Start Date
January 2016 (undefined)
Primary Completion Date
December 2017 (Anticipated)
Study Completion Date
December 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hangzhou Cancer Hospital

4. Oversight

Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Esophageal Cancer, Endostatin
Keywords
Endostatin, Oxaliplatin, Esophageal Cancer, chemoradiotherapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
22 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Chemoradiotherapy Arm
Arm Type
Experimental
Arm 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.
Intervention Type
Drug
Intervention Name(s)
Endostatins
Intervention Description
Endostatin will be administered at a dose of 7.5 mg/m2/day concurrent with radiotherapy.
Intervention Type
Drug
Intervention Name(s)
Oxaliplatin
Intervention Description
Oxaliplatin (135mg/m², d1) will be administered on Day 1 and Day 29 of radiotherapy.
Intervention Type
Radiation
Intervention Name(s)
Radiotherapy
Intervention Description
Radiotherapy will be delivered with a daily fraction of 2.0 Gy to a total dose of 60 Gy over 6 weeks.
Primary Outcome Measure Information:
Title
response rate
Description
Response rate will be done after 3-4 weeks following the last radiotherapy session.
Time Frame
week 3-4
Secondary Outcome Measure Information:
Title
Acute and late toxicities assessed based on the common toxicity criteria for adverse events version 3.0 (CTCAEv3.0)
Description
Acute and late toxicities will be assessed based on the common toxicity criteria for adverse events version 3.0 (CTCAEv3.0).
Time Frame
year 0 - year 3
Title
Progression-free survival
Description
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.
Time Frame
year 0 - year 3
Title
Overall survival
Description
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.
Time Frame
year 0 - year 3

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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;
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Shixiu Wu, MD
Phone
+8657186826086
Email
wushixiu@medmail.com.cn
Facility Information:
Facility Name
Hangzhou Cancer Hospital
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shixiu Wu, MD
Phone
+8657186826086
Email
wushixiu@medmail.com.cn
First Name & Middle Initial & Last Name & Degree
Tao Song, Dr
Email
songtaodhp@126.com

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
30850562
Citation
Li W, Chen P, Zhang N, Song T, Wu S. Endostatin and Oxaliplatin-Based Chemoradiotherapy for Inoperable Esophageal Squamous Cell Carcinoma: Results of a Phase II Study. Oncologist. 2019 Apr;24(4):461-e136. doi: 10.1634/theoncologist.2019-0119. Epub 2019 Mar 8.
Results Reference
derived

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

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