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Efficacy of Chemotherapy Alone in Patients With Poor-differentiated Early-stage Cervical Cancer

Sponsor
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University (Other)
Overall Status
Recruiting
CT.gov ID
NCT05863377
Collaborator
(none)
450
Enrollment
1
Location
36
Anticipated Duration (Months)
12.5
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This study is aimed to enroll patients with early-stage cervical cancer (FIGO 2018 IB1-IB2) who undergo radical hysterectomy and the postoperative pathology doesn't meet Sedlis criteria or the "four-factor" model but with poorly differentiated squamous/adenocarcinoma/adenosquamous carcinoma. Patients will be randomly divided into two groups in a 1:1 ratio. The experimental group received 4 courses of paclitaxel and cisplatin (once every 3 weeks) for adjuvant chemotherapy within 4 weeks after surgery, while the control group don't not receive any adjuvant therapy but only received regular follow-up. The disease status of all patients will be evaluated within 4 weeks after the end of all treatment and every 12 weeks thereafter, including gynecological examination, laboratory indicators, imaging evaluation, and the prognosis of the two groups will be compared.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    450 participants
    Observational Model:
    Cohort
    Time Perspective:
    Retrospective
    Official Title:
    The Efficacy of Chemotherapy Alone in Patients With Poor-differentiated Early-stage Cervical Cancer But Without the Criteria for Adjuvant Radiotherapy According to NCCN Guidelines
    Actual Study Start Date :
    Jan 1, 2022
    Anticipated Primary Completion Date :
    Dec 31, 2024
    Anticipated Study Completion Date :
    Dec 31, 2024

    Arms and Interventions

    Arm Intervention/Treatment
    Adjuvant Chemotherapy Group

    The patients of this group receive adjuvant chemotherapy after surgery.
    No-Further Treatment Group

    The patients of this group only receive regular follow-up without adjuvant therapy.

    Outcome Measures

    Primary Outcome Measures

    1. Progress Free Survival (PFS) [5 years]

      The time between surgery and clinical recurrence.

    Secondary Outcome Measures

    1. Overall Survival (OS) [5 years]

      The time interval between the cancer diagnosis and the death of any reason.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 70 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    1. The age of patients is 18-70 years old.

    2. Patients with cervical cancer who undergo radical hysterectomy and pelvic lymphadenectomy as initial treatment (including laparoscopic and abdominal surgery).

    3. Clinical stage is IB1-IB2 according to FIGO 2018 stage.

    4. The postoperative pathological type is squamous cell carcinoma/adenocarcinoma/adenosquamous carcinoma.

    5. The degree of tumor differentiation is poorly differentiated.

    6. Do not meet the Sedlis criteria or the four-factor model, but meet one of the following factors: ① LVSI (+); ② tumor diameter > 2cm; ③ Depth of cervical stromal invasion > superficial 1/3; (4) adenocarcinoma.

    Exclusion Criteria:

    1. Postoperative pathological stage ≥IIA (according to the 2018 FIGO staging system).

    2. Patients with the following high risk factors: ① lymph node metastasis; ② parametrial involvement; ③ positive surgical margin; ④ vaginal involvement.

    3. Patients received neoadjuvant chemotherapy.

    4. There was evidence of distant metastasis on preoperative imaging examination.

    5. Patients received postoperative radiotherapy.

    6. History of abdominal or pelvic radiotherapy.

    7. Patients with other malignant tumors.

    8. Patients with missing or partially missing clinical, surgical, and pathological data were lost to follow-up.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 The Sun Yat-Sen Memorial Hospital of Sun Yat-Sen Universit Guangzhou Guangdong China

    Sponsors and Collaborators

    • Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
    ClinicalTrials.gov Identifier:
    NCT05863377
    Other Study ID Numbers:
    • SYSEC-KY-KS-2021-197
    First Posted:
    May 18, 2023
    Last Update Posted:
    May 18, 2023
    Last Verified:
    Jan 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
    early-stage
    chemotherapy alone
    poor differentiation
    Additional relevant MeSH terms:
    Uterine Cervical Neoplasms

    Study Results

    No Results Posted as of May 18, 2023