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

Sponsor
Shanghai Jiao Tong University School of Medicine (Other)
Overall Status
Recruiting
CT.gov ID
NCT05455632
Collaborator
(none)
200
Enrollment
1
Location
25
Anticipated Duration (Months)
8
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    200 participants
    Observational Model:
    Cohort
    Time Perspective:
    Retrospective
    Official Title:
    Can Postoperative Radiotherapy be Omitted for Oral Squamous Cell Carcinoma Patients Underwent Neoadjuvant Therapy and Surgery? - A Retrospective Cohort Study
    Actual Study Start Date :
    Jun 1, 2022
    Anticipated Primary Completion Date :
    Jun 30, 2023
    Anticipated Study Completion Date :
    Jun 30, 2024

    Arms and Interventions

    Arm Intervention/Treatment
    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

    Outcome Measures

    Primary Outcome Measures

    1. OS [24 months]

      Overall survival

    Secondary Outcome Measures

    1. LRFS [24 months]

      Local recurrence-free rate

    2. QOL [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 [24 months]

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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 75 Years
    Sexes Eligible for Study:
    All
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine Shanghai Shanghai China 20011

    Sponsors and Collaborators

    • 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 Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Lai-ping Zhong, Professor, Shanghai Jiao Tong University School of Medicine
    ClinicalTrials.gov Identifier:
    NCT05455632
    Other Study ID Numbers:
    • PORT-NAT
    First Posted:
    Jul 13, 2022
    Last Update Posted:
    Jul 14, 2022
    Last Verified:
    Jul 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Carcinoma
    Carcinoma, Squamous Cell
    Squamous Cell Carcinoma of Head and Neck

    Study Results

    No Results Posted as of Jul 14, 2022