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

Completed

• Conditions: Surgery; Neoadjuvant Therapy; Radiotherapy; Oral Squamous Cell Carcinoma

• Registration Number: NCT05455632
• Lead Sponsor: Shanghai Jiao Tong University School of Medicine

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-06-01
• Study First Submitted: 2022-07-09
• Study First Submitted QC: 2022-07-09
• Study First Posted: 2022-07-13
• Primary Completion: 2022-12-30
• Study Completion: 2023-04-30
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-21
• Last Update Posted: 2023-11-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 192

Inclusion Criteria

• 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

Exclusion Criteria

• 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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
OS	24 months	Overall survival

Secondary Outcome Measures

Name	Time	Method
QOL	24 months	Quality of life (QOL), according to the QLQ-C30 scoring manual, the final QOL scores of each field are transformed into standardized scores within 0-100 through linear transformation
LRFS	24 months	Local recurrence-free rate
OS-MPR	24 months	Overall survival for patients obtained major pathological response (MPR) from neoadjuvant therapy

Trial Locations

Locations (1)

Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine; 🇨🇳 Shanghai, Shanghai, China