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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
67
Drug: Nimotuzumab Radiation: Intensity Modulated Radiation Therapy
Department of radiation oncology, Fujian cancer hospital
Fuzhou, Fujian, China
RECRUITINGTumor response rate after Nimotuzumab concurrent with radiotherapy for recurrent NPC patients
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.
Time frame: Three month after patients subject to the treatment
Toxicity of this combined treatment for recurrent NPC patients
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
Time frame: Three month after patients subject to the treatment
Local Progression free survival
Time frame: Three years
Disease-free survival
Defined as the time in month from all treatment were finished to the date of disease progress is observed.
Time frame: Three years
Overall survival
Defined as the time in month from diagnosis of recurrent NPC to the date of death is observed or to last follow-up visit.
Time frame: Three years
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.