Can Postoperative Radiotherapy be Omitted for Oral Squamous Cell Carcinoma Patients Underwent Neoadjuvant Therapy and Surgery? - A Retrospective Cohort Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 192
- Locations
- 1
- Primary Endpoint
- OS
Study Overview
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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Retrospective
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
OS
Time Frame: 24 months
Overall survival
Secondary Outcomes
- QOL(24 months)
- LRFS(24 months)
- OS-MPR(24 months)
Investigators
Lai-ping Zhong
Professor
Shanghai Jiao Tong University School of Medicine