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Endostar Combined With Concurrent Chemoradiotherapy for Locoregionally Advanced Nasopharyngeal Carcinoma

Primary Purpose

Nasopharyngeal Carcinoma

Status
Unknown status
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
Endostar
DDP
Sponsored by
First Affiliated Hospital of Guangxi Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Nasopharyngeal Carcinoma focused on measuring Nasopharyngeal carcinoma, endostar, chemoradiotherapy

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. patients of either gender and aged from 18 to 70 years old.
  2. patients with histologically confirmed non-keratinizing squamous cell nasopharyngeal carcinoma.
  3. patients at stage III/IVb by UICC2010 staging.
  4. KPS ≥ 70 (Appendix I)
  5. patients with available MRI data of nasopharynx and measurable tumor lesions.
  6. patients did not receive any treatment before enrollment.
  7. patients with expected survival longer than 6 months.
  8. biochemical indexes: hemoglobin > 120 g/L, WBC > 4 x 109 /L, and blood platelet ≥ 100 x 109 /L; levels of indicators for hepatic and renal function was 1.25 folds of the upper limit of normal value.
  9. the informed content was obtained from every patient.
  10. patients with effective follow-up.

Exclusion Criteria:

  1. those with malignant tumors other than nasopharyngeal carcinoma, stage I non-melanoma skin cancer, and cervical carcinoma in situ.
  2. those received treatments before enrollment.
  3. pregnant or lactating women and reproductive women without contraception.
  4. those who were undergoing other drug trials.
  5. those with severe complications, including myocardial infarction, severe arrhythmia, severe cerebrovascular disease, ulcer disease, mental illness and uncontrollable diabetes.
  6. those who could not be followed up at regular intervals.
  7. those who were treated with tumor targeting drugs.
  8. those who could not subject to MRI examination.
  9. those who could not meet the requirements of the prescribed dose.
  10. those with hemorrhagic tendency.

Sites / Locations

  • The First Affiliated Hospital of Guangxi Medical University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

concurrent chemoradiotherapy + endostar

concurrent chemoradiotherapy

Arm Description

Drug: Endostar Endostar 7.5mg / m2,3 cycles of intravenous infusion for ten days, and 2 cycles of maintenance therapy after radiotherapy Drug: DDP DDP 100mg / m2, intravenous infusion over 2 hours , for 2-3 cycles Radiation: IMRT IMRT:70-74Gy

Drug: DDP DDP 100mg / m2, intravenous infusion over 2 hours , for 2-3 cycles Radiation: IMRT IMRT:70-74Gy

Outcomes

Primary Outcome Measures

3-year Progression Free Survival
The subjects were randomly divided into two groups. Group A: concurrent chemoradiotherapy combined with Endostar，including 3 cycles of intravenous infusion, and 2 cycles of maintenance therapy after radiotherapy，and Group B: concurrent chemoradiotherapy, concurrent chemotherapy for 2 or 3 cycles. After treatment, the subjects go into observation period. MRI will be used for evaluating the carcinoma status. During 3 years, any relapse or death will be recorded.

Secondary Outcome Measures

5-year Overall Survival
The subjects were randomly divided into two groups. Group A: concurrent chemoradiotherapy combined with Endostar，including 3 cycles of intravenous infusion, and 2 cycles of maintenance therapy after radiotherapy，and Group B: concurrent chemoradiotherapy, concurrent chemotherapy for 2 or 3 cycles. After treatment, the subjects go to observation period for 5 years.

Full Information

First Posted
September 13, 2016
Last Updated
September 15, 2016
Sponsor
First Affiliated Hospital of Guangxi Medical University
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1. Study Identification

Unique Protocol Identification Number
NCT02907710
Brief Title
Endostar Combined With Concurrent Chemoradiotherapy for Locoregionally Advanced Nasopharyngeal Carcinoma
Official Title
A Multicenter, Prospective, Randomized Controlled Clinical Trial Comparing Endostar With Concurrent Chemoradiotherapy and Concurrent Chemoradiotherapy in the Treatment of Locoregionally Advanced Nasopharyngeal Carcinoma (NPC)
Study Type
Interventional

2. Study Status

Record Verification Date
September 2016
Overall Recruitment Status
Unknown status
Study Start Date
October 2016 (undefined)
Primary Completion Date
November 2018 (Anticipated)
Study Completion Date
November 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
First Affiliated Hospital of Guangxi Medical University

4. Oversight

5. Study Description

Brief Summary
A total of 300 patients with pathologically confirmed Locoregionally advanced nasopharyngeal carcinoma were enrolled. Patients were randomly divided into two groups, with 150 patients in each group. One group was treated with Concurrent Chemoradiotherapy combined with Endostar and the other group was treated with Concurrent Chemoradiotherapy. The short term efficacy and the toxic and side effects of these treatments were evaluated. The 1-year, 3-year, 5-year overall survival and progression-free survival of patients were analyzed. The investigators data may provide an alternative option for the treatment of Locoregionally advanced nasopharyngeal carcinoma with high efficacy and low toxicity.
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. Five medical centers participated in this study and 300 patients with pathologically confirmed Locoregionally advanced nasopharyngeal carcinoma were enrolled. These patients were stratified according to clinical stage and participating center, and were randomly divided into two groups: concurrent chemoradiotherapy combined with Endostar group ( IMRT 70-74Gy, Endostar 7.5mg / m2, 3 cycles of intravenous infusion, and 2 cycles of maintenance therapy after radiotherapy) and concurrent chemoradiotherapy group ( IMRT 70-74Gy, DDP 100mg / m2, intravenous infusion over 2 hours , for 2-3 cycles). After treatment, follow-up was performed every 3 months. The treatment toxicity, local control rate, distant metastasis-free survival, overall survival, progression-free survival were observed and assessed.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nasopharyngeal Carcinoma
Keywords
Nasopharyngeal carcinoma, endostar, chemoradiotherapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
300 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
concurrent chemoradiotherapy + endostar
Arm Type
Experimental
Arm Description
Drug: Endostar Endostar 7.5mg / m2,3 cycles of intravenous infusion for ten days, and 2 cycles of maintenance therapy after radiotherapy Drug: DDP DDP 100mg / m2, intravenous infusion over 2 hours , for 2-3 cycles Radiation: IMRT IMRT:70-74Gy
Arm Title
concurrent chemoradiotherapy
Arm Type
Active Comparator
Arm Description
Drug: DDP DDP 100mg / m2, intravenous infusion over 2 hours , for 2-3 cycles Radiation: IMRT IMRT:70-74Gy
Intervention Type
Drug
Intervention Name(s)
Endostar
Other Intervention Name(s)
recombinant human endostatin
Intervention Description
intravenous infusion
Intervention Type
Drug
Intervention Name(s)
DDP
Primary Outcome Measure Information:
Title
3-year Progression Free Survival
Description
The subjects were randomly divided into two groups. Group A: concurrent chemoradiotherapy combined with Endostar，including 3 cycles of intravenous infusion, and 2 cycles of maintenance therapy after radiotherapy，and Group B: concurrent chemoradiotherapy, concurrent chemotherapy for 2 or 3 cycles. After treatment, the subjects go into observation period. MRI will be used for evaluating the carcinoma status. During 3 years, any relapse or death will be recorded.
Time Frame
3 years
Secondary Outcome Measure Information:
Title
5-year Overall Survival
Description
The subjects were randomly divided into two groups. Group A: concurrent chemoradiotherapy combined with Endostar，including 3 cycles of intravenous infusion, and 2 cycles of maintenance therapy after radiotherapy，and Group B: concurrent chemoradiotherapy, concurrent chemotherapy for 2 or 3 cycles. After treatment, the subjects go to observation period for 5 years.
Time Frame
5 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: patients of either gender and aged from 18 to 70 years old. patients with histologically confirmed non-keratinizing squamous cell nasopharyngeal carcinoma. patients at stage III/IVb by UICC2010 staging. KPS ≥ 70 (Appendix I) patients with available MRI data of nasopharynx and measurable tumor lesions. patients did not receive any treatment before enrollment. patients with expected survival longer than 6 months. biochemical indexes: hemoglobin > 120 g/L, WBC > 4 x 109 /L, and blood platelet ≥ 100 x 109 /L; levels of indicators for hepatic and renal function was 1.25 folds of the upper limit of normal value. the informed content was obtained from every patient. patients with effective follow-up. Exclusion Criteria: those with malignant tumors other than nasopharyngeal carcinoma, stage I non-melanoma skin cancer, and cervical carcinoma in situ. those received treatments before enrollment. pregnant or lactating women and reproductive women without contraception. those who were undergoing other drug trials. those with severe complications, including myocardial infarction, severe arrhythmia, severe cerebrovascular disease, ulcer disease, mental illness and uncontrollable diabetes. those who could not be followed up at regular intervals. those who were treated with tumor targeting drugs. those who could not subject to MRI examination. those who could not meet the requirements of the prescribed dose. those with hemorrhagic tendency.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
min kang, doctor
Phone
0086-0771-5356509
Email
km1019@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
sheng ren wang, doctor
Organizational Affiliation
First Affiliated Hospital of Guangxi Medical University
Official's Role
Study Chair
Facility Information:
Facility Name
The First Affiliated Hospital of Guangxi Medical University
City
Nanning
State/Province
Guangxi
ZIP/Postal Code
530021
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
sheng ren wang, doctor
Phone
0086-13807806008
Email
13807806008@163.com
First Name & Middle Initial & Last Name & Degree
min kang, doctor
Phone
0086-15977724416
Email
km1019@163.com
First Name & Middle Initial & Last Name & Degree
ming he lu, doctor
First Name & Middle Initial & Last Name & Degree
min shao lin, bachelor
First Name & Middle Initial & Last Name & Degree
zheng fu zhang, bachelor
First Name & Middle Initial & Last Name & Degree
yuan dai ma, doctor

12. IPD Sharing Statement

Citations:
PubMed Identifier
15752890
Citation
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Citation
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PubMed Identifier
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Citation
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Results Reference
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PubMed Identifier
10640954
Citation
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PubMed Identifier
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Citation
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PubMed Identifier
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Citation
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PubMed Identifier
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Citation
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Results Reference
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Endostar Combined With Concurrent Chemoradiotherapy for Locoregionally Advanced Nasopharyngeal Carcinoma

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