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

Surgery Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05455632
• Other study ID #: PORT-NAT
• Status: Completed
• Start date: June 1, 2022
• Est. completion date: April 30, 2023

Study information

• Verified date: November 2023
• Source: Shanghai Jiao Tong University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 192
• Est. completion date: April 30, 2023
• Est. primary completion date: December 30, 2022
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Squamous Cell
• Neoadjuvant Therapy
• Oral Squamous Cell Carcinoma
• Radiotherapy
• Squamous Cell Carcinoma of Head and Neck
• Surgery

Locations

Country	Name	City	State
China	Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Jiao Tong University School of Medicine

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	OS	Overall survival	24 months
Secondary	LRFS	Local recurrence-free rate	24 months
Secondary	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
Secondary	OS-MPR	Overall survival for patients obtained major pathological response (MPR) from neoadjuvant therapy	24 months