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

Shanghai Jiao Tong University School of Medicine

Status: Completed

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

Study type: Observational

Funder types: Other

Identifiers

NCT05455632

PORT-NAT

Details and patient eligibility

About

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.

Enrollment: 192 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

192 participants in 2 patient groups

Group1:PORT

Description:

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

Group2:non-PORT

Description:

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