Predictive Factor Analysis of Acute Radiation Oral Mucositis in Nasopharyngeal Carcinoma Patients Treated With Precise Radiotherapy Technique Combined Chemotherapy
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Nasopharyngeal Carcinoma
- Sponsor
- Zhejiang Cancer Hospital
- Enrollment
- 200
- Locations
- 1
- Primary Endpoint
- the highest grade of oral mucositis
- Last Updated
- 7 years ago
Overview
Brief Summary
Radiation induced oral mucositis which may result in reduced quality of life is commonly seen during radiotherapy, especially combined with chemotherapy. This study is a prospective, single center, and exploratory study. Two contour methods of oral mucosal will be used in this study. All detail information will be recorded prospectively. The aim of this study is to explore predictive factors of acute radiotherapy induced oral mucositis in nasopharyngeal carcinoma patients treated with new precise radiotherapy (intensity modulated radiotherapy or tomography radiotherapy) by using different dosimetric parameters and clinically relevant variables.
Detailed Description
To prospectively identify the predictive value of different dosimetric parameters and assess the predictors of acute radiation oral mucositis in nasopharyngeal carcinoma patients treated with intensity modulated radiotherapy or tomography radiotherapy.
Investigators
Chen yuanyuan
Clinical Professor
Zhejiang Cancer Hospital
Eligibility Criteria
Inclusion Criteria
- •1.Clinical diagnosis of nasopharyngeal carcinoma. 2.7th version American Joint Committee on Cancer (AJCC) stage II-IVB. 3.Age must above
- •4.Performance status must be 0 or 1 according to Eastern Cooperative Oncology Group.
- •5.Adequate bone marrow, renal, and hepatic function.
Exclusion Criteria
- •Treatment with palliative intent.
- •Previous malignancy.
- •Pregnancy or lactation.
- •A history of previous radiotherapy, chemotherapy, or surgery (except diagnostic) to the primary tumor or nodes.
- •Any severe coexisting disease.
Outcomes
Primary Outcomes
the highest grade of oral mucositis
Time Frame: oral mucocitis will be checked every day during the date of initiation of radiation therapy until the date of completion of radiation therapy, the highest grade ≥ 3 define as severe oral mubocitis, assessed up to a month and a half
Radiation Therapy Oncology Group/European Organization for research and treatment acute radiation morbidity scoring criteria. Grade 0: No change over baseline, Grade 1: Injection/ may experience mild pain not requiring analgesic, Grade 2: Patchy mucositis which may produce an inflammatory serosanguinitis discharge/ may experience moderate pain requiring analgesia, Grade 3: Confluent fibrinous mucositis/ may include severe pain requiring narcotic, Grade 4: Ulceration, hemorrhage or necrosis, Grade 5: death (Higher score equals to worse outcome).