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Effect of Endostar Combined With Intensity-modulated Radiotherapy Compare With Chemoradiation for Locoregionally Advanced,Low-risk Nasopharyngeal Carcinoma

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ClinicalTrials.gov Identifier: NCT02237924
Recruitment Status : Not yet recruiting
First Posted : September 12, 2014
Last Update Posted : September 16, 2014
Sponsor:
Information provided by (Responsible Party):
min kang, First Affiliated Hospital of Guangxi Medical University

Brief Summary:
A total of 120 patients with pathologically confirmed locally advanced low-risk nasopharyngeal carcinoma were enrolled. They were randomly divided into two groups, with 60 patients in each group. One group was treated with intensity-modulated radiation therapy (IMRT) combined with Endostar and the other group was treated with IMRT combined with concurrent chemotherapy. 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. Our data may provide an alternative option for the treatment of locally advanced low-risk nasopharyngeal carcinoma with high efficacy and low toxicity.

Condition or disease Intervention/treatment Phase
Nasopharyngeal Carcinoma Drug: endostar Drug: DDP Radiation: IMRT Phase 2

Detailed Description:
This study was a multicenter, open-label, 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. Six medical centers participated in this study and 120 patients with pathologically confirmed locally advanced low-risk nasopharyngeal carcinoma were enrolled. These patients were stratified according to clinical stage and participating center, and were randomly divided into two groups: IMRT combined with Endostar group ( IMRT 70-74Gy, Endostar 7.5mg / m2, 2 cycles of intravenous infusion, and 2 cycles of maintenance therapy after radiotherapy) and IMRT combined with concurrent chemotherapy 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effect of Endostar Combined With Intensity-modulated Radiotherapy Compare With Chemoradiation for Locoregionally Advanced,Low-risk Nasopharyngeal Carcinoma.
Study Start Date : September 2014
Estimated Primary Completion Date : September 2020
Estimated Study Completion Date : October 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: endostar + IMRT Drug: endostar
Endostar 7.5mg / m2, 2 cycles of intravenous infusion for ten days,and 2 cycles of maintenance therapy after radiotherapy

Radiation: IMRT
IMRT:70-74Gy for 2-3 cycles

Active Comparator: DDP + IMRT Drug: DDP
DDP:80mg/m2 for 2-3 cycles

Radiation: IMRT
IMRT:70-74Gy for 2-3 cycles




Primary Outcome Measures :
  1. 5-year Overall Survival [ Time Frame: 6 years ]
    The subjects were randomly divided into two groups. Group A: IMRT combined with Endostar ,including 2 cycles of intravenous infusion, and 2 cycles of maintenance therapy after radiotherapy,and Group B: IMRT combined with concurrent chemotherapy for 2 or 3 cycles. After treatment, the subjects go to observation period for 5 years.


Secondary Outcome Measures :
  1. 3-year Progression Free Survival [ Time Frame: 4 years ]
    The subjects were randomly divided into two groups. Group A: IMRT combined with Endostar ,including 2 cycles of intravenous infusion , and 2 cycles of maintenance therapy after radiotherapy,and Group B: IMRT combined with 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.



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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/IVM0 by UICC2010 staging; patients with higher risk factors (such as N3 and T4N2) were excluded.
  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.

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): NCT02237924


Contacts
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Contact: sheng ren Wang, doctor 0086-0771-5356509 13807806008@163.com
Contact: Min Kang, doctor 0086-0771-5356509 km1019@163.com

Locations
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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: lian mei Liu, master         
Sub-Investigator: qian hong Wang, Bachelor         
Sub-Investigator: hui si Liao, bachelor         
Sub-Investigator: min shao Lin, bachelor         
Sub-Investigator: xian jin Zhu, master         
Sub-Investigator: xin hai Huang, bachelor         
Sponsors and Collaborators
First Affiliated Hospital of Guangxi Medical University
Investigators
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Study Director: Sheng ren Wang, doctor First Affiliated Hospital of Guangxi Medical University

Publications:

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Responsible Party: min kang, doctor, First Affiliated Hospital of Guangxi Medical University
ClinicalTrials.gov Identifier: NCT02237924     History of Changes
Other Study ID Numbers: S201413__19
First Posted: September 12, 2014    Key Record Dates
Last Update Posted: September 16, 2014
Last Verified: September 2014

Keywords provided by min kang, First Affiliated Hospital of Guangxi Medical University:
nasopharyngeal carcinoma
endostar
IMRT
chemoradiation

Additional relevant MeSH terms:
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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
Carcinoma
Pharyngeal Diseases
Stomatognathic Diseases
Otorhinolaryngologic Diseases
Endostar protein
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Antineoplastic Agents