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Selective Pelvic Lymphadenectomy for IB-IIA Cervical Cancer

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ClinicalTrials.gov Identifier: NCT03295526
Recruitment Status : Recruiting
First Posted : September 28, 2017
Last Update Posted : September 28, 2017
Sponsor:
Information provided by (Responsible Party):
Xiaohua Wu MD, Fudan University

Brief Summary:

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


Condition or disease Intervention/treatment Phase
Cervical Cancer Procedure: Lymph nodes debulking surgery. Phase 2

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Study on Selective Pelvic Lymphadenectomy for IB-IIA Cervical Cancer
Actual Study Start Date : September 1, 2017
Estimated Primary Completion Date : September 1, 2018
Estimated Study Completion Date : September 1, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cervical Cancer

Arm Intervention/treatment
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




Primary Outcome Measures :
  1. 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).


Secondary Outcome Measures :
  1. 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.

  2. Lower extremities lymphedema [ Time Frame: 3 year ]
    Lymphedema Staging standards (Stage 0-3) according to the"consensus document"of the International Society of Lymphology.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03295526


Contacts
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Contact: Shanhui Liang, Dr 008618616890863 dr_lianshanhui@163.com

Locations
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China, Shanghai
Fudan university Recruiting
Shanghai, Shanghai, China, 021
Contact: Liang shanhui, Dr    008618616890863    dr_liangshanhui@163.com   
Sponsors and Collaborators
Fudan University
Investigators
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Principal Investigator: Xiaohua WU, PhD & MD Fudan university shanghai cancer center, Deparment of gynecologic oncology

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Responsible Party: Xiaohua Wu MD, Professor, Fudan University
ClinicalTrials.gov Identifier: NCT03295526     History of Changes
Other Study ID Numbers: STCSM2016-6-17-1.1
First Posted: September 28, 2017    Key Record Dates
Last Update Posted: September 28, 2017
Last Verified: September 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Xiaohua Wu MD, Fudan University:
Cervical Cancer, Lymph nodes debulking surgery

Additional relevant MeSH terms:
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Uterine Cervical Neoplasms
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Uterine Cervical Diseases
Uterine Diseases
Genital Diseases, Female