Endostar Combined With Induction Chemotherapy and Concurrent Chemoradiotherapy for Locoregional Nasopharyngeal Carcinoma

Endostar Continuous Intravenous Infusion Combined With Induction Chemotherapy and Concurrent Chemoradiotherapy for Locoregionally Advanced Nasopharyngeal Carcinoma (NPC).

Endostar Continuous Intravenous Infusion Combined With Induction Chemotherapy and Concurrent Chemoradiotherapy for Locoregionally Advanced Nasopharyngeal Carcinoma.

Study Overview

• Status: Not yet recruiting
• Conditions: Nasopharyngeal Carcinoma
• Intervention / Treatment: Drug: Endostar; Drug: Cisplatin; Drug: Docetaxel; Radiation: Intensity Modulated Radiation Therapy (IMRT)

Detailed Description

This study was a multicenter, prospective, randomized controlled clinical trial. A set of unified standards were used, including the clinical research program, inclusion criteria, exclusion criteria, chemoradiotherapy regimen and evaluation criteria. A total of 73 patients with pathologically confirmed locoregionally advanced nasopharyngeal carcinoma would be enrolled. Patients were randomly divided into two groups, with 48 patients in the combination group and 25 patients in the control group. The combination group was treated with Induction and Concurrent Chemoradiotherapy combined with Endostar. The control group was treated with Induction and Concurrent Chemoradiotherapy. The short term efficacy and side effects of these treatments would be evaluated. The 1-year, 3-year progression-free survival and overall survival would be analyzed. This data of this study might provide an alternative option for the treatment of Locoregionally advanced nasopharyngeal carcinoma with higher efficacy and low toxicity.

• Study Type: Interventional
• Enrollment (Anticipated): 73
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Xia He, M.D., Ph.D.; Phone Number: 8625-83283597; Email: hexia206@163.com
• Study Contact Backup: Name: Juying Liu, M.D., Ph.D.; Phone Number: 8625-83283596; Email: peteadam@yeah.net

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Pathologically or clinically confirmed locally recurrent nasopharyngeal carcinoma;
2. No chemotherapy, immunotherapy, radiotherapy treatment history.
3. No evidence of distant metastasis
4. Eastern Cooperative Oncology Group performance score 0-1
5. Normal bone marrow function: white blood cell count > 3.5 × 109 / L, hemoglobin > 90 g / L and platelet count > 100 × 109 / L.
6. Normal liver function: Alanine aminotransferase (ALT), aspartate aminotransferase (AST) <1.5 times the upper limit of normal (ULN), and alkaline phosphatase (ALP) < 2.5 × ULN
7. Normal renal function: creatinine clearance > 60 ml/min.
8. The patient must be informed of the basic content of the study and sign an informed consent form.

Exclusion Criteria:

1. The pathological type is keratinized squamous cell carcinoma or basal squamous cell carcinoma.
2. Treatment is palliative.
3. A history of malignant tumors, except for well-treated basal cell carcinoma or squamous cell carcinoma and cervical carcinoma in situ.
4. Women during pregnancy or lactation (pregnancy tests should be considered for women of childbearing age; effective contraception should be emphasized during treatment).
5. Previous radiation therapy (except for non-melanoma skin cancer with a previous lesion outside the target area of radiotherapy).
6. Primary and cervical metastatic lesions have received chemotherapy or surgery (except for diagnostic treatment).
7. Having other serious illnesses may result in greater risk or affect the compliance of the trial. For example: kidney disease, chronic hepatitis, control of unsatisfactory diabetes (fasting blood glucose > 1.5 × ULN), and mental illness.
8. A history of severe heart disease, including: cardiac function ≥ standard II, unstable angina, myocardial infarction, arrhythmia - antiarrhythmic drug therapy (except beta-blockers or digoxin), Uncontrollable hypertension.
9. According to the investigator's judgment, there are people with concomitant diseases that seriously endanger the safety of the patient or affect the patient's completion of the study.
10. Patients with a major bleeding tendency in the primary nasopharyngeal tumors.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental group; Drug: Endostar Drug: Cisplatin Drug: Docetaxel Radiation	Drug: Endostar; Endostar, 15 mg/m2, continous intravenous infusion, 3 cycles during induction chemotherapy, 4 cycles during concurrent chemoradiotherapy.; Other Names: Recombinant human endostatin injection; Drug: Cisplatin; Cisplatin, 75 mg/m2, intravenous infusion, 3 cycles during induction chemotherapy; Cisplatin, 80 mg/m2, intravenous infusion, 2 cycles during concurrent chemoradiotherapy.; Drug: Docetaxel; Docetaxel, 75 mg/m2, intravenous infusion, 3 cycles during induction chemotherapy.; Radiation: Intensity Modulated Radiation Therapy (IMRT); IMRT: 66 Gy, 2-2.2 Gy per fraction, a total of 33 fractions
Other: Control group; Drug: Cisplatin Drug: Docetaxel Radiation	Drug: Cisplatin; Cisplatin, 75 mg/m2, intravenous infusion, 3 cycles during induction chemotherapy; Cisplatin, 80 mg/m2, intravenous infusion, 2 cycles during concurrent chemoradiotherapy.; Drug: Docetaxel; Docetaxel, 75 mg/m2, intravenous infusion, 3 cycles during induction chemotherapy.; Radiation: Intensity Modulated Radiation Therapy (IMRT); IMRT: 66 Gy, 2-2.2 Gy per fraction, a total of 33 fractions

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
progression-free survival (PFS)	Progression Free Survival is defined as the time from enrollment to the date of first documented disease progression or death from any cause	Approximately 36 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
objective response rate	Complete response (CR)+Partial response (PR) according to RECIST 1.1	18months
overall survival (OS)	Overall survival was defined as the time from randomization to death from any cause	Approximately 36 months
adverse event (AE)	adverse event according to NCI-CTCAE (5.0)	Approximately 36 months

Collaborators and Investigators

• Sponsor: Jiangsu Cancer Institute & Hospital
• Investigators: Principal Investigator: Xia He, M.D., Ph.D., Jiangsu Cancer Institute & Hospital

Study record dates

Study Major Dates

• Study Start (Anticipated): June 1, 2019
• Primary Completion (Anticipated): September 1, 2022
• Study Completion (Anticipated): September 1, 2023

Study Registration Dates

• First Submitted: November 22, 2017
• First Submitted That Met QC Criteria: April 28, 2019
• First Posted (Actual): April 30, 2019

Study Record Updates

• Last Update Posted (Actual): April 30, 2019
• Last Update Submitted That Met QC Criteria: April 28, 2019
• Last Verified: April 1, 2019

More Information

Terms related to this study

• Keywords: Chemoradiotherapy; Nasopharyngeal Carcinoma; Endostar; Endostatin
• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Neoplasms, Glandular and Epithelial; Pharyngeal Neoplasms; Otorhinolaryngologic Neoplasms; Head and Neck Neoplasms; Nasopharyngeal Diseases; Pharyngeal Diseases; Stomatognathic Diseases; Otorhinolaryngologic Diseases; Nasopharyngeal Neoplasms; Carcinoma; Nasopharyngeal Carcinoma; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Antineoplastic Agents; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Angiogenesis Inhibitors; Angiogenesis Modulating Agents; Growth Substances; Growth Inhibitors; Docetaxel; Endostar protein; Endostatins
• Other Study ID Numbers: Endo-Naso-001

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No