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Endostar Combined With Concurrent Chemoradiotherapy for Locoregionally Advanced Nasopharyngeal Carcinoma

This study is not yet open for participant recruitment.
Verified September 2016 by min kang, First Affiliated Hospital of Guangxi Medical University
Sponsor:
ClinicalTrials.gov Identifier:
NCT02907710
First Posted: September 20, 2016
Last Update Posted: September 20, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
min kang, First Affiliated Hospital of Guangxi Medical University
  Purpose
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.

Condition Intervention Phase
Nasopharyngeal Carcinoma Drug: Endostar Drug: DDP Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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)

Resource links provided by NLM:


Further study details as provided by min kang, First Affiliated Hospital of Guangxi Medical University:

Primary Outcome Measures:
  • 3-year Progression Free Survival [ Time Frame: 3 years ]
    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 [ Time Frame: 5 years ]
    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.


Estimated Enrollment: 300
Study Start Date: October 2016
Estimated Study Completion Date: November 2019
Estimated Primary Completion Date: November 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: concurrent chemoradiotherapy + endostar

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: Endostar
intravenous infusion
Other Name: recombinant human endostatin
Drug: DDP
Active Comparator: concurrent chemoradiotherapy

Drug: DDP

DDP 100mg / m2, intravenous infusion over 2 hours , for 2-3 cycles

Radiation: IMRT

IMRT:70-74Gy

Drug: DDP

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.
  Eligibility

Information from the National Library of Medicine

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

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.
  Contacts and Locations
Information from the National Library of Medicine

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): NCT02907710


Contacts
Contact: min kang, doctor 0086-0771-5356509 km1019@163.com

Locations
China, Guangxi
The First Affiliated Hospital of Guangxi Medical University Not yet recruiting
Nanning, Guangxi, China, 530021
Contact: sheng ren wang, doctor    0086-13807806008    13807806008@163.com   
Contact: min kang, doctor    0086-15977724416    km1019@163.com   
Sub-Investigator: ming he lu, doctor         
Sub-Investigator: min shao lin, bachelor         
Sub-Investigator: zheng fu zhang, bachelor         
Sub-Investigator: yuan dai ma, doctor         
Sponsors and Collaborators
First Affiliated Hospital of Guangxi Medical University
Investigators
Study Chair: sheng ren wang, doctor First Affiliated Hospital of Guangxi Medical University
  More Information

Publications:

Responsible Party: min kang, doctor, First Affiliated Hospital of Guangxi Medical University
ClinicalTrials.gov Identifier: NCT02907710     History of Changes
Other Study ID Numbers: FirstGuangxiMU
First Submitted: September 13, 2016
First Posted: September 20, 2016
Last Update Posted: September 20, 2016
Last Verified: September 2016

Keywords provided by min kang, First Affiliated Hospital of Guangxi Medical University:
Nasopharyngeal carcinoma
endostar
chemoradiotherapy

Additional relevant MeSH terms:
Carcinoma
Nasopharyngeal Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Pharyngeal Neoplasms
Otorhinolaryngologic Neoplasms
Head and Neck Neoplasms
Neoplasms by Site
Nasopharyngeal Diseases
Pharyngeal Diseases
Stomatognathic Diseases
Otorhinolaryngologic Diseases
Endostatins
Antineoplastic Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors