Selective Pelvic Lymphadenectomy for IB-IIA Cervical Cancer

August 18, 2020 updated by: Xiaohua Wu MD, Fudan University

Study on Selective Pelvic Lymphadenectomy for IB-IIA Cervical Cancer

Test name:

Study on selective pelvic lymphadenectomy for IB - IIA cervical cancer Researcher: Wu Xiaohua Research Center: Fudan University Shanghai Cancer Center The trial is expected to last for 3 years Test objectives： The primary goal：The overall therapeutic effect of patients with selective lymphadenectomy was not inferior to patients with systemic pelvic lymphadenectomy.

Secondary goal: Selective lymphadenectomy can reduce the incidence and severity of postoperative lower limb lymphedema.

The study was designed for prospective, randomized, controlled clinical trials. The number of subjects: 200 cases. Research groupings Selective pelvic lymphadenectomy group and The control group was treated with systematic pelvic lymph node dissection group.

Follow-up time: 3 years Sample size: 200 cases

End of the trial:

Primary end-poin:t three-year survival (overall survival, progression-free survival) Secondary end point: lower limb lymph node lymphedema

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Overall objective For cervical cancer patients with confirmed lymph node metastasis by intraoperative frozen pathology, the overall treatment effect of radical hysterectomy and selective enlarged lymph node dissection is not inferior to systematic pelvic lymphadenectomy and can reduce postoperative lower limb lymphedema incidence and severity.

1. The purpose of this study

  1. to assess whether the progression free survival of patients with selective enlarged pelvic lymph node resection is better than patients with systematic pelvic lymph node dissection.
  2. to evaluate differences of the incidence and severity of lymphedema between the two group patients using Lymphedema Staging standards (Stage 0-3) according to the"consensus document"of the International Society of Lymphology.

2. Preoperative evaluation LEEP, conization or biopsy Vagino-recto-abdominal examination + Vaginal / vaginal colposcopy examination History of Medical, surgical and childbearing Complications Physical condition Height and weight History of smoking Pregnancy test Chest X-ray or chest CT or general PET/CT Abdominal CT or general PET/CT Pelvic MRI/CT or general PET/CT

3.Protocol Patients with stage IB-IIa cervical cancer were randomly divided into two groups(Control group and Experimental group).Frozen pathological examination will be performed during the operation, and patients with positive lymph node metastasis will undergo radical hysterectomy and systematic pelvic lymphadenectomy or radical hysterectomy and selective enlarged lymph node dissection according to the patient's group.

4. Postoperative adjuvant therapy All patients with pelvic lymph node metastasis are required to receive DDP based concurrent chemoradiotherapy.

5.Efficacy evaluation Overall survival (OS): The period from randomization to death for any cause (for patients who have been loss to follow-up prior to death, the last follow-up time is calculated as the time of death).

Progression free survival (PFS): The duration from randomization to the earliest date of the date of tumor progression or the date of death for any cause. If the above standards are not met, the final evaluation date should be used for analysis.

Assessment of lymphedema in lower extremities: Lymphedema Staging standards (Stage 0-3) according to the"consensus document"of the International Society of Lymphology were used :

Stage 0 Subclinical with possible clinical evolution Stage I Edema regressing with treatments with positive pitting test Stage II Edema partially regressing with treatments with negative pitting test Stage III Elephantiasis with cutaneous complications and recurrent infections.

6. Follow up The patients were followed up every 3 months for the first year, every 4 months for the second year and every 6 months from the third year.

In addition to routine oncologic follow-up, the stage of patients̛ lower extremity lymphedema should also be evaluated.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
200

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China, 021
        • Recruiting
        • Fudan University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  1. histology confirmed as cervical adenocarcinoma, squamous cell carcinoma or adenosquamous carcinoma.
  2. histological grading of cervical cancer is 1, 2, 3 or not.
  3. patients in the group must have no reproductive function requirements.
  4. Patients must be ≥ 18 years of age.
  5. preoperative: pelvic CT / MR or PET / CT suggest pelvic lymph node enlargement. Intraoperative: Patients with pelvic lymph node metastasis confirmed by freezing.
  6. Signed informed consent.
  7. Surgery should be completed within 4 weeks after the first diagnosis.
  8. patients can receive treatment and follow-up.

Exclusion Criteria:

  1. abdominal CT, PET / CT suggest that patients with para aortic lymph node metastasis.
  2. other history of the tumor, but does not include: received appropriate treatment of non-melanoma skin cancer, has been cured of other solid tumors, has been cured or non Hodgkin's lymphoma and Hodgkin's lymphoma 5 years without recurrence.
  3. Those who have received or will receive neoadjuvant chemotherapy.
  4. patients with preoperative limb lymphedema or lower extremity venous and lymphatic reflux disorders.
  5. pregnant women

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
No Intervention: Control group
IB-IIA Cervical Cancer Patients with positive lymph node metastasis confirmed by intraoperative frozen pathological examination who will undergo radical hysterectomy and systematic pelvic lymphadenectomy
Experimental: Experimental group
IB-IIA Cervical Cancer Patients with positive lymph node metastasis confirmed by intraoperative frozen pathological examination who will undergo radical hysterectomy and selective enlarged lymph node dissection.
Procedure: Lymph nodes debulking surgery.
Radical hysterectomy and selective enlarged lymph node dissection

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Overall survival (OS)
Time Frame: 3 year
The period(months) from randomization to death for any cause (for patients who have been loss to follow-up prior to death, the last follow-up time is calculated as the time of death).
3 year

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Progression-Free-Survival (PFS)
Time Frame: 3 year
The period(months) from randomization to the earliest date of the date of tumor progression or the date of death for any cause. If the above standards are not met, the final evaluation date should be used for analysis.
3 year
Lower extremities lymphedema
Time Frame: 3 year
Lymphedema Staging standards (Stage 0-3) according to the"consensus document"of the International Society of Lymphology.
3 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Fudan University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Xiaohua WU, PhD & MD, Fudan university shanghai cancer center, Deparment of gynecologic oncology

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2017

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 1, 2022

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 1, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 12, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 24, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 28, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 19, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 18, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • STCSM2016-6-17-1.1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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