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Nimotuzumab for Recurrent Nasopharyngeal Carcinoma

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ClinicalTrials.gov Identifier: NCT03666221
Recruitment Status : Recruiting
First Posted : September 11, 2018
Last Update Posted : September 11, 2018
Sponsor:
Collaborators:
Sun Yat-sen University
Jiangxi Provincial Cancer Hospital
Zhejiang Cancer Hospital
Fujian Medical University Union Hospital
Information provided by (Responsible Party):
Fujian Cancer Hospital

Brief Summary:
The study assessed the clinical efficacy, and safety of the combination of Nimotuzumab administered concomitantly with intensity modulated radiation therapy(IMRT) in patients with recurrent nasopharyngeal cancer.

Condition or disease Intervention/treatment Phase
Recurrent Nasopharyngeal Carcinoma Drug: Nimotuzumab Phase 2

Detailed Description:
The clinical efficacy of Nimotuzumab combined with radiotherapy has been shown in advanced nasopharyngeal cancer, which was significantly higher than radiotherapy alone. The efficacy of radiotherapy combined with Nimotuzumab has not been confirmed in recurrent nasopharyngeal cancer.In this study, Phase II clinical trials were performed. The patients were treated with Nimotuzumab which were used concurrently with IMRT. The efficacy and toxicity will be assessed.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 67 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open,Multicenter,Phase II Trial of Intensity Modulated Radiation Therapy Combined With Concurrent Nimotuzumab in Patient With Recurrent Nasopharyngeal Carcinoma
Actual Study Start Date : November 1, 2014
Estimated Primary Completion Date : April 1, 2020
Estimated Study Completion Date : November 1, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Nimotuzumab plus IMRT
Patients with recurrent nasopharyngeal carcinoma were given an initial dose of nimotuzumab (200 mg) 7days before receiving concurrent intensity modulated radiation therapy(IMRT) , folowing weekly nimotuzumab (200 mg/week) for totally 8 weeks concurrent with IMRT.
Drug: Nimotuzumab
Drug: Nimotuzumab Radiation: Intensity Modulated Radiation Therapy
Other Name: Radiation




Primary Outcome Measures :
  1. Tumor response rate after Nimotuzumab concurrent with radiotherapy for recurrent NPC patients [ Time Frame: Three month after patients subject to the treatment ]
    The response status (Complete Response + Partial Response) was evaluated according to RECIST (Response Evaluation Criteria in Solid Tumors) criteria. Complete response was defined as disappearance of all target lesions, and Partial response was defined as at least a 30% reduction in the sum of the longest diameter of target lesions, taking as reference the baseline study.

  2. Toxicity of this combined treatment for recurrent NPC patients [ Time Frame: Three month after patients subject to the treatment ]
    Adverse events of this combined modality treatment were graded according to CTCAE (Common Terminology Criteria for Adverse Events) v3.0 criteria.Toxicity Criteria for Adverse Events version 3.0


Secondary Outcome Measures :
  1. Local Progression free survival [ Time Frame: Three years ]
  2. Disease-free survival [ Time Frame: Three years ]
    Defined as the time in month from all treatment were finished to the date of disease progress is observed.

  3. Overall survival [ Time Frame: Three years ]
    Defined as the time in month from diagnosis of recurrent NPC to the date of death is observed or to last follow-up visit.



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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. Patients with recurrent tumor in nasopharynx with or without relapse cervical lymph nodes more than 6 months after initial radical treatment.
  2. Recurrent nasopharyngeal cancer was confirmed by pathology, marginal recurrence can be diagnosed by imaging examinations.
  3. Age 18-70.
  4. At least one of the tumor lesions measurable.
  5. Functional Status: PS (ECOG) > 0-1.
  6. Normal Bone Marrow Function: White blood cell count > 4×109/L, hemoglobin >90g/L, and platelet count >100×109/L.
  7. Normal Hepatic and Renal Function: Alanine Tminotransferase (ALT)/Aspartate Aminotransferase (AST) < 2.5 times the upper limit of normal (ULN), while total bilirubin (T-Bil) < 1.5 x ULN and serum creatinine < 1.5 x ULN.
  8. Life expectancy of more than 6 months.
  9. All the patients signed the informed consent.
  10. Follow up regularly and comply with test requirements.

Exclusion Criteria:

  1. Patients with recurrent cervical lymph nodes alone.
  2. Evidence of distant metastasis
  3. The relapse tumor has been treated with chemotherapy, radiotherapy, surgery, immunotherapy and other anti-tumor therapy.
  4. Creatinine clearance < 30ml/min
  5. Has received epidermal growth factor targeting therapy.
  6. Second malignancy within 5 years(except of Non-melanoma Skin Cancer or carcinoma in situ of cervix).
  7. Serious complications, such as uncontrolled hypertension, coronary heart disease, diabetes, heart failure, etc.
  8. Active systemic infection.
  9. History of Serious lung or heart disease.
  10. Drug or alcohol addiction.
  11. Persons without capacity for civil conduct or persons with limited capacity for civil conduct.
  12. The patient has physical or mental disorders and is believed to be unable to fully or fully understand the possible complications of the study.
  13. To receive chronic systemic immunotherapy or hormone therapy other than this study.
  14. Women who are pregnant or breast feeding
  15. Participation in other drugs clinical trials within 1 month.

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): NCT03666221


Contacts
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Contact: SHAOJUN LIN, Dr. 0591-62752225 linshaojun@yeah.net

Locations
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China, Fujian
Department of radiation oncology, Fujian cancer hospital Recruiting
Fuzhou, Fujian, China, 350014
Contact: SHAOJUN LIN, master    0086-0591-62752225    linshaojun@yeah.net   
Sponsors and Collaborators
Fujian Cancer Hospital
Sun Yat-sen University
Jiangxi Provincial Cancer Hospital
Zhejiang Cancer Hospital
Fujian Medical University Union Hospital

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Responsible Party: Fujian Cancer Hospital
ClinicalTrials.gov Identifier: NCT03666221     History of Changes
Other Study ID Numbers: NPC001.2
First Posted: September 11, 2018    Key Record Dates
Last Update Posted: September 11, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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 Fujian Cancer Hospital:
Nimotuzumab
IMRT
Radiation
Recurrent
Nasopharyngeal Carcinoma

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
Nimotuzumab
Antineoplastic Agents, Immunological
Antineoplastic Agents