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

Phase 2

• Conditions: Esophageal Cancer; Endostatin
• Interventions: Drug: Endostatins; Drug: Oxaliplatin; Radiation: Radiotherapy

• Registration Number: NCT02745561
• Lead Sponsor: Hangzhou Cancer Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-01
• Status Verified: 2016-04
• Study First Submitted: 2016-04-18
• Study First Submitted QC: 2016-04-19
• Last Update Submitted: 2016-04-19
• Study First Posted: 2016-04-20
• Last Update Posted: 2016-04-20
• Primary Completion: 2017-12
• Study Completion: 2018-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 22

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;

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Chemoradiotherapy Arm	Radiotherapy	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.
Chemoradiotherapy Arm	Oxaliplatin	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.
Chemoradiotherapy Arm	Endostatins	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.

Primary Outcome Measures

Name	Time	Method
response rate	week 3-4	Response rate will be done after 3-4 weeks following the last radiotherapy session.

Secondary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Hangzhou Cancer Hospital; 🇨🇳 Hangzhou, Zhejiang, China