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
|Condition or disease||Intervention/treatment||Phase|
|Recurrent Nasopharyngeal Carcinoma||Drug: Nimotuzumab||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||67 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
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 Radiation: Intensity Modulated Radiation Therapy
Other Name: Radiation
- 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.
- 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
- Local Progression free survival [ Time Frame: Three years ]
- 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.
- 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.
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
|Contact: SHAOJUN LIN, Dr.||email@example.com|
|Department of radiation oncology, Fujian cancer hospital||Recruiting|
|Fuzhou, Fujian, China, 350014|
|Contact: SHAOJUN LIN, master 0086-0591-62752225 firstname.lastname@example.org|