Clinical Trials Logo

Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT03932266
Other study ID # Endo-Naso-001
Secondary ID
Status Not yet recruiting
Phase Phase 2
First received
Last updated
Start date June 2019
Est. completion date September 2023

Study information

Verified date April 2019
Source Jiangsu Cancer Institute & Hospital
Contact Xia He, M.D., Ph.D.
Phone 8625-83283597
Email hexia206@163.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 73
Est. completion date September 2023
Est. primary completion date September 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years to 70 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Drug:
Endostar
Endostar, 15 mg/m2, continous intravenous infusion, 3 cycles during induction chemotherapy, 4 cycles during concurrent chemoradiotherapy.
Cisplatin
Cisplatin, 75 mg/m2, intravenous infusion, 3 cycles during induction chemotherapy; Cisplatin, 80 mg/m2, intravenous infusion, 2 cycles during concurrent chemoradiotherapy.
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

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Jiangsu Cancer Institute & Hospital

Outcome

Type Measure Description Time frame Safety issue
Primary 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 objective response rate Complete response (CR)+Partial response (PR) according to RECIST 1.1 18months
Secondary overall survival (OS) Overall survival was defined as the time from randomization to death from any cause Approximately 36 months
Secondary adverse event (AE) adverse event according to NCI-CTCAE (5.0) Approximately 36 months
See also
  Status Clinical Trial Phase
Recruiting NCT05979961 - Phase III Trial of Concurrent Chemotherapy Alone in Patients With Low-risk Nasopharyngeal Carcinoma Phase 3
Active, not recruiting NCT04242199 - Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of INCB099280 in Participants With Advanced Solid Tumors Phase 1
Recruiting NCT05415098 - Study of Safety, Pharmacokinetic and Efficacy of APG-5918 in Advanced Solid Tumors or Lymphomas Phase 1
Recruiting NCT06055816 - Gemcitabine Combined With Endostar and Envafolimab in Elderly Patients With Locally Advanced Nasopharyngeal Carcinoma Phase 2
Recruiting NCT05547971 - Development of Intelligent Model for Radioactive Brain Damage of Nasopharyngeal Carcinoma Based on Radio-metabolomics
Not yet recruiting NCT05020925 - SHR-1701 in Combination With Famitinib in Patients With Recurrent/Metastatic Nasopharyngeal Carcinoma Phase 1/Phase 2
Not yet recruiting NCT04547088 - Camrelizumab Combined With Apatinib in Patients With First-line Platinum-resistant Recurrent/Metastatic Nasopharyngeal Carcinoma Phase 2
Not yet recruiting NCT04548271 - Camrelizumab Combined With Apatinib in Patients With PD-1 Antagonists Resistant Recurrent/Metastatic Nasopharyngeal Carcinoma Phase 2
Recruiting NCT02795169 - Trail Evaluating Carbon Ion Radiotherapy With Concurrent Chemotherapy for Locally Recurrent Nasopharyngeal Carcinoma Phase 1/Phase 2
Terminated NCT02569788 - Trail Evaluating Carbon Ion Radiotherapy for Locally Recurrent Nasopharyngeal Carcinoma Phase 1/Phase 2
Terminated NCT02801487 - Trial Evaluating Carbon Ion Radiotherapy With Concurrent Chemotherapy for Locally Recurrent Nasopharyngeal Carcinoma Phase 1/Phase 2
Completed NCT02237924 - Endostar Combined With Intensity-modulated Radiotherapy Compare With Chemoradiation for Nasopharyngeal Carcinoma Phase 2
Recruiting NCT02044562 - Dietary Nitrate on Plasma Nitrate Levels for Nasopharyngeal Carcinoma Patients N/A
Terminated NCT01694576 - NPC Staged N2-3M0:Adjuvant Chemotherapy or Just Observation After Concurrent Chemoradiation Phase 2
Recruiting NCT01462903 - A Study of Adoptive Immunotherapy With Autologous Tumor Infiltrating Lymphocytes in Solid Tumors Phase 1
Completed NCT01271439 - Study of Chemoradiotherapy Combined With Cetuximab in Nasopharyngeal Carcinoma Phase 2
Completed NCT00535795 - Phase III: Assess Conventional RT w/ Conventional Plus Accelerated Boost RT in the Treatment of Nasopharyngeal CA Phase 3
Completed NCT00379262 - Therapeutic Gain by Induction-concurrent Chemoradiotherapy and/or Accelerated Fractionation for Nasopharyngeal Carcinoma Phase 3
Completed NCT03398980 - Late Sequelae of Childhood and Adolescent Nasopharyngeal Carcinoma Survivors After Radiotherapy N/A
Completed NCT01309633 - Study Evaluating Two Loading Regimens of Sunitinib or Bevacizumab Alternating With Cisplatin and Gemcitabine as Induction Therapy for Locally Advanced Nasopharyngeal Carcinoma (NPC) Phase 2