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

NCT02745561 | Unknown Phase 2

• 1 other identifier: HangzhouCH05
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

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.

Conditions

Esophageal Cancer; Endostatin

Keywords

Endostatin; Oxaliplatin; Esophageal Cancer; chemoradiotherapy

Outcome Measures

Primary Outcomes (1)

• response rate

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

  week 3-4

Secondary Outcomes (3)

• Acute and late toxicities assessed based on the common toxicity criteria for adverse events version 3.0 (CTCAEv3.0)

  year 0 - year 3

• Progression-free survival

  year 0 - year 3

• Overall survival

  year 0 - year 3

Study Arms (1)

Chemoradiotherapy Arm

EXPERIMENTAL

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; Drug: Oxaliplatin; Radiation: Radiotherapy

Interventions

Endostatins DRUG

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

Chemoradiotherapy Arm

Oxaliplatin DRUG

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

Chemoradiotherapy Arm

Radiotherapy RADIATION

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

Chemoradiotherapy Arm

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

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;
• 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;

Sponsors & Collaborators

• Hangzhou Cancer Hospital: lead

Study Sites (1)

Hangzhou Cancer Hospital

Hangzhou, Zhejiang, 310000, China

RECRUITING

Related Publications (1)

• 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.

  PMID: 30850562 DERIVED

MeSH Terms

Conditions

Esophageal Neoplasms

Interventions

Endostatins; Oxaliplatin; Radiotherapy

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)

Angiostatic Proteins; Angiogenic Proteins; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Collagen Type XVIII; Non-Fibrillar Collagens; Collagen; Extracellular Matrix Proteins; Scleroproteins; Biological Factors; Coordination Complexes; Organic Chemicals; Therapeutics

Central Study Contacts

Shixiu Wu, MD

CONTACT

+8657186826086; wushixiu@medmail.com.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: April 18, 2016
• First Posted: April 20, 2016
• Study Start: January 1, 2016
• Primary Completion: December 1, 2017
• Study Completion: December 1, 2018
• Last Updated: April 20, 2016

Record last verified: 2016-04

Locations

CN (1)