A Bidirectional Study of Individualized Postoperative Adjuvant Treatment Decision Model for Locally Advanced Head and Neck Squamous Cell Carcinoma Based on Multimodal Dynamic Data

NCT07532928 | Enrolling By Invitation DMC

• 1 other identifier: NFEC-2025-364
• Study Type: observational
• Target: 571
• Locations: 1 country
• Sites: 1

Brief Summary

Based on multimodal data, we establish a dynamic deep learning model to conduct prognostic risk assessment for patients and recommend the 'most suitable' treatment/follow-up regimen after radical treatment, assisting clinicians in improving homogenized evaluation levels and achieving individualized precision therapy, thereby providing scientific evidence for the currently widely debated selection of postoperative adjuvant therapy in locally advanced head and neck squamous cell carcinoma patients.

Conditions

Deep Learning; Head & Neck Squamous Cell Carcinoma

Keywords

Head & neck squamous cell carcinoma; Deep Learning

Outcome Measures

Primary Outcomes (1)

• 2-year progress-free survival

  From the initiation of treatment to the date of tumor progression (including local recurrence, regional lymph node metastasis, and distant metastasis) or tumor-related death, whichever occurs first. If no progression event was observed by the cutoff date of follow-up, the last follow-up date was used.

  2 years

Secondary Outcomes (2)

• 2-year overall survival

  2 years

• 2-year recurrence-free survival

  2 years

Study Arms (3)

Postoperative concurrent chemoradiotherapy group

For observational studies, participants are not assigned an intervention as part of the study. Patients in this group received postoperative concurrent chemoradiotherapy. The specific regimen was as follows: a total radiation dose of 60-66 Gy was delivered in 30-33 fractions over a treatment course of 6-7 weeks. Chemotherapy consisted of either cisplatin monotherapy (75 mg/m², once every 3 weeks) or a combination of cisplatin and 5-fluorouracil (cisplatin 75 mg/m², 5-fluorouracil 750 mg/m², once every 3 weeks), administered concurrently with radiotherapy.

Postoperative radiotherapy group

For observational studies, participants are not assigned an intervention as part of the study. Patients in this group received postoperative radiotherapy alone. The specific regimen was as follows: a total radiation dose of 60-66 Gy was delivered in 30-33 fractions, over a total treatment course of 6-7 weeks.

Postoperative observation group

For observational studies, participants are not assigned an intervention as part of the study. Patients in this group received no postoperative adjuvant therapy and were only followed up regularly.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients diagnosed and treated at Nanfang Hospital, Southern Medical University or its cooperative hospitals between January 2017 and December 2025.

You may qualify if:

• Age \>= 18 years.
• Patients diagnosed and treated at Nanfang Hospital, Southern Medical University or its cooperative hospitals between January 2017 and December 2025.
• Patients who either seek medical treatment after June 2022 or sought medical treatment before that but have not lost contact with the hospital for more than 1 year are required to sign the informed consent form voluntarily.
• Newly diagnosed head and neck squamous cell carcinoma (HNSCC) confirmed by histopathology.
• Locally advanced disease without distant metastasis.
• Complete clinical data (including patient demographics, tumor characteristics, treatment details, and prognostic variables).
• Availability of MRI, CT, or PET-CT images before and after radical treatment.

You may not qualify if:

• History of or coexisting secondary malignancies.
• Lack of definitive radical treatment.
• Absence of baseline or follow-up imaging (MRI/CT/PET-CT).
• Investigator-determined unsuitability for study participation.

Sponsors & Collaborators

• Nanfang Hospital, Southern Medical University: lead
• Peking University Shenzhen Hospital: collaborator

Study Sites (1)

510000

Guangzhou, 510000, China

Location

MeSH Terms

Conditions

Squamous Cell Carcinoma of Head and Neck

Condition Hierarchy (Ancestors)

Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Head and Neck Neoplasms; Neoplasms by Site

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: OTHER
• Target Duration: 3 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 8, 2026
• First Posted: April 16, 2026
• Study Start: August 15, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2028
• Last Updated: April 16, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)