Postoperative Radiotherapy for Oral Squamous Cell Carcinoma After Neoadjuvant Therapy and Surgery

NCT05455632 | Completed

• 1 other identifier: PORT-NAT
• Study Type: observational
• Target: 192
• Locations: 1 country
• Sites: 1

Brief Summary

The treatment guideline for locally advanced resectable oral squamous cell carcinoma (LAROSCC) is surgery + postoperative radiotherapy/chemoradiotherapy. Though the treatment is intensive with serious harm to quality of life, the survival of patients is poor. Neoadjuvant therapy has been evaluated in a number of clinical trials for LAROSCC, but failed to directly improve the overall survival. On the other hand, de-escalation of treatment followed by neoadjuvant is also been explored with some promising results. This study is to retrospectively include patients with LAROSCC who received neoadjuvant therapy and surgery. Survival between patients in two cohorts (cohort 1: received postoperative radiotherapy, cohort 2: received no postoperative radiotherapy) are to be compared.

Conditions

Radiotherapy; Neoadjuvant Therapy; Oral Squamous Cell Carcinoma; Surgery

Outcome Measures

Primary Outcomes (1)

• OS

  Overall survival

  24 months

Secondary Outcomes (3)

• LRFS

  24 months

• QOL

  24 months

• OS-MPR

  24 months

Study Arms (2)

Group1:PORT

Oral squamous cell carcinoma (OSCC) patients received neoadjuvant therapy, surgery, and postoperative radiotherapy.

Group2:non-PORT

Oral squamous cell carcinoma (OSCC) patients received neoadjuvant therapy and surgery, without postoperative radiotherapy

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Oral squamous cell carcinoma (OSCC) patients received neoadjuvant therapy and surgery with and without postoperative radiotherapy in the Department of Oral and Maxillofacial-Head and Neck Oncology in Ninth People's Hospital, Shanghai JiaoTong University School of Medicine from January 2008 to December 2021.

You may qualify if:

• Patients receiving neoadjuvant therapy and surgery for oral squamous cell carcinoma from January 2008 to December 2021
• Oral squamous cell carcinoma histology (including tongue, gingiva, cheek, floor of mouth, hard palate and posterior molar area)
• Clinical stage III/IVA (T1-2/N1-2/M0 or T3-4/cN0-2/M0, AJCC 2018) for the primary lesion
• Surgical resection samples that can be evaluated for pathological remission rate

You may not qualify if:

• Severe/active systemic disease
• Previously radiotherapy or neck lymph node dissection for the head and neck region
• Evidence of tumor recurrence or metastasis in physical examination or imaging (ultrasound, CT, MRI) before initiation adjuvant radiotherapy
• Evidence of severe/unrelieved side effects of neoadjuvant therapy or severe postoperative complications before initiation adjuvant radiotherapy

Sponsors & Collaborators

• Shanghai Jiao Tong University School of Medicine: lead

Study Sites (1)

Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine

Shanghai, Shanghai Municipality, 20011, China

Location

Related Publications (1)

• Ju W, Zhang Y, Liu Y, Sun J, Li J, Dong M, Sun Q, Shi W, Zhao T, Zhou Z, Huang Y, Zhou X, Zhu D, Dou S, Zhang Z, He Y, Zhang C, Xia R, Zhu G, Zhong L. Can adjuvant radiotherapy be omitted for oral cavity cancer patients who received neoadjuvant therapy and surgery? A retrospective cohort study. Int J Surg. 2023 Apr 1;109(4):879-886. doi: 10.1097/JS9.0000000000000353.

  PMID: 36999830 DERIVED

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 Officials

• Lai-ping Zhong

  Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: July 9, 2022
• First Posted: July 13, 2022
• Study Start: June 1, 2022
• Primary Completion: December 30, 2022
• Study Completion: April 30, 2023
• Last Updated: November 22, 2023

Record last verified: 2023-11

Locations

CN (1)