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OpenTrials
Completed

NCT Number: NCT05455632

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

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.

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Key information

Conditions

Radiotherapy Carcinoma Carcinoma, Squamous Cell Head and Neck Neoplasms Neoadjuvant Therapy Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Oral Squamous Cell Carcinoma Squamous Cell Carcinoma of Head and Neck Surgery

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

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

Shanghai, Shanghai Municipality, 20011, China

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. OS

    Time frame: 24 months

    Overall survival

Secondary outcomes

  1. LRFS

    Time frame: 24 months

    Local recurrence-free rate

  2. QOL

    Time frame: 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

  3. OS-MPR

    Time frame: 24 months

    Overall survival for patients obtained major pathological response (MPR) from neoadjuvant therapy

Sponsors and collaborators

Lead sponsor

Shanghai Jiao Tong University School of Medicine

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2022
Study completion
2023
First posted
Jul 13, 2022
Registry last updated
Nov 22, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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