Predictor Analysis of Acute Radiation Oral Mucositis in NPC Patients Treated With IMRT/TOMO Combined Chemotherapy

Nasopharyngeal Carcinoma Clinical Trial

Official title:

Predictive Factor Analysis of Acute Radiation Oral Mucositis in Nasopharyngeal Carcinoma Patients Treated With Precise Radiotherapy Technique Combined Chemotherapy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03647527
• Other study ID #: PF-AROM-NPC-IMRT/TOMO
• Status: Recruiting
• Start date: September 1, 2016
• Est. completion date: January 31, 2019

Study information

• Verified date: August 2018
• Source: Zhejiang Cancer Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: January 31, 2019
• Est. primary completion date: November 30, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1.Clinical diagnosis of nasopharyngeal carcinoma. 2.7th version American Joint Committee on Cancer (AJCC) stage II-IVB. 3.Age must above 18. 4.Performance status must be 0 or 1 according to Eastern Cooperative Oncology Group.

5.Adequate bone marrow, renal, and hepatic function.

Exclusion Criteria:

1. Treatment with palliative intent.

2. Previous malignancy.

3. Pregnancy or lactation.

4. A history of previous radiotherapy, chemotherapy, or surgery (except diagnostic) to the primary tumor or nodes.

5. Any severe coexisting disease.

Related Conditions & MeSH terms

• Carcinoma
• Mucositis
• Nasopharyngeal Carcinoma
• Nasopharyngeal Neoplasms
• Stomatitis

Locations

Country	Name	City	State
China	Zhejiang Cancer Hospital	Hangzhou	Zhejiang

Sponsors (1)

Lead Sponsor	Collaborator
Zhejiang Cancer Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the highest grade of oral mucositis	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).	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