Clinical trial NCT02745561: 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
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Esophageal Cancer
Endostatin
Keywords: Endostatin
Oxaliplatin
Esophageal Cancer
chemoradiotherapy
Lead sponsor: Hangzhou Cancer Hospital
Sponsor class: OTHER
First posted: 2016-04-20
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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;

Primary outcomes:
measure: response rate
timeFrame: week 3-4
Secondary outcomes:
measure: Acute and late toxicities assessed based on the common toxicity criteria for adverse events version 3.0 (CTCAEv3.0)
timeFrame: year 0 - year 3
measure: Progression-free survival
timeFrame: year 0 - year 3
measure: Overall survival
timeFrame: year 0 - year 3
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: Hangzhou Cancer Hospital
state: Zhejiang
Study officials:
References:
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.