Efficacy of Chemotherapy Alone in Patients With Poor-diff... | NCT05863377

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

NCT05863377

Sponsor

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

Status

Unknown status

Last Update Posted

May 18, 2023Actual

Enrollment

450Estimated

Phase

Not provided

Conditions

Cervical Cancer

Interventions

Not provided

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2023

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1, 2022Actual

Primary Completion Date

Dec 31, 2024Estimated

Completion Date

Dec 31, 2024Estimated

First Submitted Date

Apr 28, 2023

First Submission Date that Met QC Criteria

May 16, 2023

First Posted Date

May 18, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 16, 2023

Last Update Posted Date

May 18, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

450Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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.

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Progress Free Survival (PFS)	The time between surgery and clinical recurrence.	5 years

Secondary Outcomes

Measure	Description	Time Frame
Overall Survival (OS)	The time interval between the cancer diagnosis and the death of any reason.	5 years

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

The age of patients is 18-70 years old.
Patients with cervical cancer who undergo radical hysterectomy and pelvic lymphadenectomy as initial treatment (including laparoscopic and abdominal surgery).
Clinical stage is IB1-IB2 according to FIGO 2018 stage.
The postoperative pathological type is squamous cell carcinoma/adenocarcinoma/adenosquamous carcinoma.
The degree of tumor differentiation is poorly differentiated.
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:

Postoperative pathological stage ≥IIA (according to the 2018 FIGO staging system).
Patients with the following high risk factors: ① lymph node metastasis; ② parametrial involvement; ③ positive surgical margin; ④ vaginal involvement.
Patients received neoadjuvant chemotherapy.
There was evidence of distant metastasis on preoperative imaging examination.
Patients received postoperative radiotherapy.
History of abdominal or pelvic radiotherapy.
Patients with other malignant tumors.
Patients with missing or partially missing clinical, surgical, and pathological data were lost to follow-up.

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Patients with early-stage (FIGO 2018 IB1-IB2 stage) poorly differentiated cervical cancer diagnosed with radical surgery

Sampling Method

Probability Sample

Name	Role	Phone	Extension	Email
Huaiwu Lu, Study Director	Contact	+86 18688395806		luhuaiwu@mail.sysu.edu.cn

Facility	Status	City	State	ZIP	Country	Contacts
The Sun Yat-Sen Memorial Hospital of Sun Yat-Sen Universit	Recruiting	Guangzhou	Guangdong		China

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
31401822	Background	Paik ES, Lim MC, Kim MH, Kim YH, Song ES, Seong SJ, Suh DH, Lee JM, Lee C, Choi CH. Prognostic Model for Survival and Recurrence in Patients with Early-Stage Cervical Cancer: A Korean Gynecologic Oncology Group Study (KGOG 1028). Cancer Res Treat. 2020 Jan;52(1):320-333. doi: 10.4143/crt.2019.124. Epub 2019 Aug 5.
16427212	Background

ID	Term
D014594	Uterine Neoplasms
D005833	Genital Neoplasms, Female
D014565	Urogenital Neoplasms
D009371	Neoplasms by Site