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

Can Postoperative Radiotherapy be Omitted for Oral Squamous Cell Carcinoma Patients Underwent Neoadjuvant Therapy and Surgery? - A Retrospective Cohort Study

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.

Study Overview

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

• Study Type: Observational
• Enrollment (Actual): 192

Contacts and Locations

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 20011
      • Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A

• 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.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
OS	Overall survival	24 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
LRFS	Local recurrence-free rate	24 months
QOL	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	24 months
OS-MPR	Overall survival for patients obtained major pathological response (MPR) from neoadjuvant therapy	24 months

Collaborators and Investigators

• Sponsor: Shanghai Jiao Tong University School of Medicine
• Investigators: Principal Investigator: Lai-ping Zhong, Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2022
• Primary Completion (Actual): December 30, 2022
• Study Completion (Actual): April 30, 2023

Study Registration Dates

• First Submitted: July 9, 2022
• First Submitted That Met QC Criteria: July 9, 2022
• First Posted (Actual): July 13, 2022

Study Record Updates

• Last Update Posted (Actual): November 22, 2023
• Last Update Submitted That Met QC Criteria: November 21, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Neoplasms, Glandular and Epithelial; Head and Neck Neoplasms; Neoplasms, Squamous Cell; Carcinoma; Carcinoma, Squamous Cell; Squamous Cell Carcinoma of Head and Neck
• Other Study ID Numbers: PORT-NAT

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No