Prospective Observational Study to Predict Severe Oral Mucositis Associated With Chemoradiotherapy in Nasopharyngeal Carcinoma Based on Deep Learning

Nasopharyngeal Carcinoma Clinical Trial

Official title:

Prospective Observational Study to Predict Severe Oral Mucositis Associated With Chemoradiotherapy in Nasopharyngeal Carcinoma Based on Deep Learning

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06032767
• Other study ID #: B2022-420-Y01
• Status: Recruiting
• Start date: August 14, 2023
• Est. completion date: December 30, 2024

Study information

• Verified date: January 2024
• Source: Sun Yat-sen University
• Contact: Fang-Yun Xie, M.D.
• Phone: +8613902205880
• Email: xiefy[@]sysucc.org.cn
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The goal of this observational study is to apply the CNN-based DL method to extract the three-dimensional spatial information of IMRT dose distribution to predict the occurrence probability of serious radiotherapy and chemotherapy induced oral mucositis(SRCOM), and compare with a model based on dosimetry, NTCP or doseomics to improve the prediction accuracy of SRCOM, thus guiding the clinical planning design, reducing the occurrence probability of OM, and may have the potential value of preventing serious complications and improving the quality of life in patients with nasopharyngeal carcinoma.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 480
• Est. completion date: December 30, 2024
• Est. primary completion date: September 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Initial diagnosis, pathological histological diagnosis, the pathological type is non-keratotic carcinoma (according to the WHO pathological classification).

• Initial intensity-modulated radiotherapy (Intensity modulated radiation therapy, IMRT).

• No previous radiotherapy was received.

Exclusion Criteria:

• Patients with recurrent nasopharyngeal carcinoma.

• Radiotherapy plan cannot be obtained.

• Previous history of malignancy; previous radiotherapy.

• The primary lesion and cervical metastatic lesions have received surgical treatment (except for diagnostic treatment).

Related Conditions & MeSH terms

• Carcinoma
• Mucositis
• Nasopharyngeal Carcinoma
• Oral Mucositis
• Stomatitis

Intervention

Other:
• observational group
patients initially diagnosed with nasopharyngeal carcinoma treated with IMRT

Locations

Country	Name	City	State
China	Sun Yat-sen University Cancer Center	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Sun Yat-sen University

Country where clinical trial is conducted

China, 

References & Publications (8)

Elad S, Yarom N, Zadik Y, Kuten-Shorrer M, Sonis ST. The broadening scope of oral mucositis and oral ulcerative mucosal toxicities of anticancer therapies. CA Cancer J Clin. 2022 Jan;72(1):57-77. doi: 10.3322/caac.21704. Epub 2021 Oct 29. — View Citation

Gabrys HS, Buettner F, Sterzing F, Hauswald H, Bangert M. Design and Selection of Machine Learning Methods Using Radiomics and Dosiomics for Normal Tissue Complication Probability Modeling of Xerostomia. Front Oncol. 2018 Mar 5;8:35. doi: 10.3389/fonc.201 — View Citation

Ibragimov B, Toesca D, Chang D, Yuan Y, Koong A, Xing L. Development of deep neural network for individualized hepatobiliary toxicity prediction after liver SBRT. Med Phys. 2018 Oct;45(10):4763-4774. doi: 10.1002/mp.13122. Epub 2018 Sep 10. — View Citation

Li K, Yang L, Hu QY, Chen XZ, Chen M, Chen Y. Oral Mucosa Dose Parameters Predicting Grade >/=3 Acute Toxicity in Locally Advanced Nasopharyngeal Carcinoma Patients Treated With Concurrent Intensity-Modulated Radiation Therapy and Chemotherapy: An Indepen — View Citation

Li PJ, Li KX, Jin T, Lin HM, Fang JB, Yang SY, Shen W, Chen J, Zhang J, Chen XZ, Chen M, Chen YY. Predictive Model and Precaution for Oral Mucositis During Chemo-Radiotherapy in Nasopharyngeal Carcinoma Patients. Front Oncol. 2020 Nov 5;10:596822. doi: 10 — View Citation

Soutome S, Yanamoto S, Nishii M, Kojima Y, Hasegawa T, Funahara M, Akashi M, Saito T, Umeda M. Risk factors for severe radiation-induced oral mucositis in patients with oral cancer. J Dent Sci. 2021 Oct;16(4):1241-1246. doi: 10.1016/j.jds.2021.01.009. Epu — View Citation

Wolden SL, Chen WC, Pfister DG, Kraus DH, Berry SL, Zelefsky MJ. Intensity-modulated radiation therapy (IMRT) for nasopharynx cancer: update of the Memorial Sloan-Kettering experience. Int J Radiat Oncol Biol Phys. 2006 Jan 1;64(1):57-62. doi: 10.1016/j.i — View Citation

Zhen X, Chen J, Zhong Z, Hrycushko B, Zhou L, Jiang S, Albuquerque K, Gu X. Deep convolutional neural network with transfer learning for rectum toxicity prediction in cervical cancer radiotherapy: a feasibility study. Phys Med Biol. 2017 Oct 12;62(21):824 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	RTOG/EROTC Acute Radiation Reaction Scoring Standard	Toxicity records of oral mucosal Reaction in patients are conducted by professionally trained oncologists	through radiation therapy, an average of 7 weeks