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

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ClinicalTrials.gov Identifier: NCT03932266
Recruitment Status : Not yet recruiting
First Posted : April 30, 2019
Last Update Posted : April 30, 2019
Sponsor:
Information provided by (Responsible Party):
Dr. Xia He, Jiangsu Cancer Institute & Hospital

Study Description
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Brief Summary:
Endostar Continuous Intravenous Infusion Combined With Induction Chemotherapy and Concurrent Chemoradiotherapy for Locoregionally Advanced Nasopharyngeal Carcinoma.

Condition or disease Intervention/treatment Phase
Nasopharyngeal Carcinoma Drug: Endostar Drug: Cisplatin Drug: Docetaxel Radiation: Intensity Modulated Radiation Therapy (IMRT) Phase 2

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 73 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Endostar Continuous Intravenous Infusion Combined With Induction Chemotherapy and Concurrent Chemoradiotherapy for Locoregionally Advanced Nasopharyngeal Carcinoma (NPC).
Estimated Study Start Date : June 2019
Estimated Primary Completion Date : September 2022
Estimated Study Completion Date : September 2023

Resource links provided by the National Library of Medicine


Arms and Interventions
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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 Name: 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
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


Outcome Measures
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Primary Outcome Measures :
  1. progression-free survival (PFS) [ Time Frame: Approximately 36 months ]
    Progression Free Survival is defined as the time from enrollment to the date of first documented disease progression or death from any cause


Secondary Outcome Measures :
  1. objective response rate [ Time Frame: 18months ]
    Complete response (CR)+Partial response (PR) according to RECIST 1.1

  2. overall survival (OS) [ Time Frame: Approximately 36 months ]
    Overall survival was defined as the time from randomization to death from any cause

  3. adverse event (AE) [ Time Frame: Approximately 36 months ]
    adverse event according to NCI-CTCAE (5.0)


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03932266


Contacts
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Contact: Xia He, M.D., Ph.D. 8625-83283597 hexia206@163.com
Contact: Juying Liu, M.D., Ph.D. 8625-83283596 peteadam@yeah.net

Sponsors and Collaborators
Jiangsu Cancer Institute & Hospital
Investigators
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Principal Investigator: Xia He, M.D., Ph.D. Jiangsu Cancer Institute & Hospital
More Information
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Responsible Party: Dr. Xia He, Head of radiotherapy department, Jiangsu Cancer Institute & Hospital
ClinicalTrials.gov Identifier: NCT03932266    
Other Study ID Numbers: Endo-Naso-001
First Posted: April 30, 2019    Key Record Dates
Last Update Posted: April 30, 2019
Last Verified: April 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Dr. Xia He, Jiangsu Cancer Institute & Hospital:
Endostar
Nasopharyngeal Carcinoma
Chemoradiotherapy
Endostatin
Additional relevant MeSH terms:
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Carcinoma
Nasopharyngeal Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Nasopharyngeal Neoplasms
Pharyngeal Neoplasms
Otorhinolaryngologic Neoplasms
Head and Neck Neoplasms
Neoplasms by Site
Nasopharyngeal Diseases
Pharyngeal Diseases
Stomatognathic Diseases
Otorhinolaryngologic Diseases
 Docetaxel
Endostar protein
Endostatins
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors