Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Clinical Significance of Supraclavicular Lymph Node Dissection for Breast Cancer Patients With Ipsilateral Supraclavicular Lymph Node Metastasis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03716245
Recruitment Status : Recruiting
First Posted : October 23, 2018
Last Update Posted : February 12, 2020
Sponsor:
Information provided by (Responsible Party):
Xinhong Wu, Hubei Cancer Hospital

Brief Summary:

Breast cancer patients with ipsilateral supraclavicular lymph node metastasis are defined as Ⅲc stage (N3) according to the newly published 8th AJCC TNM staging system. No concret guide line was supported to such patients. It is still pending whether to exert supraclavicular lymph node dissection to breast cancer patients with ipsilateral supraclavicular lymph node metastasis.

To evaluate the clinical significance and complication of supraclavicular lymph node dissection for breast cancer patients with ipsilateral supraclavicular lymph node metastasis, the investigators randomize patients into two groups, one group is supraclavicular lymph node dissection with radiotherapy group, the other group is radiotherapy group.


Condition or disease Intervention/treatment Phase
Breast Cancer Stage III Procedure: supraclavicular lymph node dissection Radiation: supraclavicular area radiotherapy Not Applicable

Detailed Description:

Breast cancer is the most common cancer and the leading cause of deaths from cancer in women worldwide. Breast cancer patients with ipsilateral supraclavicular lymph node metastasis are defined as Ⅲc stage (N3) according to the newly published 8th AJCC TNM staging system. Clinical outcomes are similar for patients with ipsilateral supraclavicular lymph node metastases at first presentation and for patients with recurrent ipsilateral supraclavicular lymph node metastases. The survival rate was lower in patients with ipsilateral supraclavicular lymph node metastases than in patients with lower axillary or subclavian nodal involvement. No concrete guide line was supported to such patients. It is still pending whether to exert supraclavicular lymph node dissection to breast cancer patients with ipsilateral supraclavicular lymph node metastasis. Patients with ipsilateral supraclavicular lymph node metastases who were treated with surgery or radiotherapy and achieved good neck control were reported to achieve better survival than those for whom surgical treatment or irradiation did not result in good local control.

Patients with ipsilateral supraclavicular lymph node metastases should be offered a combined modality approach, including systemic therapy, surgery, and radiotherapy. Furthermore, local treatment, usually including axillary and supraclavicular lymph node, either by surgical clearance or by radical radiotherapy, can prevent the tumor cells from drainage, might be play a more important role. However, the role of surgical removal of the supraclavicular nodes is uncertain compared with radical radiotherapy. To our knowledge, the available literature comparing these two local treatments of ipsilateral supraclavicular lymph node metastases is scarce. Furthermore, the studies comparing the outcome of dissection of supraclavicular lymph node combined with local radiotherapy and radiotherapy of supraclavicular lymph node is also rare. All the related reports up to date have mixed them up.

To evaluate the clinical significance and complication of supraclavicular lymph node dissection for breast cancer patients with ipsilateral supraclavicular lymph node metastasis, we randomize patients into two groups, one group is supraclavicular lymph node dissection with radiotherapy group, the other group is radiotherapy group.

Therefore, in addition to investigating the role of surgical removal of the supraclavicular nodes in Chinese patients, we also try to reveal the potential difference between these two treatments, hoping to bring more insight into clinical practice.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 180 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Multicenter, Randomised, Open-label Prospective Clinical Trial to Evaluate the Clinical Significance of Supraclavicular Lymph Node Dissection for Breast Cancer Patients With Ipsilateral Supraclavicular Lymph Node Metastasis
Actual Study Start Date : February 27, 2019
Actual Primary Completion Date : February 10, 2020
Estimated Study Completion Date : February 27, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arm Intervention/treatment
Experimental: supraclavicular lymph node dissection and raidiotherapy
breast cancer patients with supraclavicular lymph node metastasis receive supraclavicular lymph node dissection and supraclavicular area radiotherapy
Procedure: supraclavicular lymph node dissection
people with supraclavicular lymph node metastasis before surgery should receive dissection of supraclavicular lymph node and the supraclavicular lymph node metastasis should be confirmed either by core needle biopsy or fine needle aspiration biopsy

Active Comparator: supraclavicular area radiotherapy
breast cancer patients with supraclavicular lymph node metastasis receive supraclavicular area radiotherapy
Radiation: supraclavicular area radiotherapy
people with supraclavicular lymph node metastasis before surgery should receive radiotherapy of supraclavicular area and the supraclavicular lymph node metastasis should be confirmed either by core needle biopsy or fine needle aspiration biopsy




Primary Outcome Measures :
  1. Disease free survival [ Time Frame: 3-5 years ]
    Disease free survival for 3 years and 5 years, which means the rate of patients without local recurrence and distant metastasis in the whole patients at the same group will be calculated with Kaplan Meier survival curves.


Secondary Outcome Measures :
  1. Occurring rate of complications [ Time Frame: 3-5 years ]
    Occurring rate of complications including the occurring rate of infection, hemorrhage, limb lymphedema, time in hospital, brachial plexopahy, radiation induced lung injury in each group were recorded in patients' medical record.

  2. Overall survival [ Time Frame: 3-5 years ]
    Overall survival for 3 years and 5 years, which means the rate of patients alive in the whole patients at the same group will be calculated with kaplan meier survival curves.

  3. Life quality score [ Time Frame: 3-5 years ]
    Life quality score was evaluated by European Organization of Research and treatment of Cancer-Questionnaire of Life Quality-C30 Version 3 (EORTC-QLQ-C30 V3), which conduct a series of questions about the patients' physical condition, activity of daily life, adverse reaction and mood condition. The range in the questionnaire for the score is from 1 to 4, in which 1 stands for having no discomfort and 4 stands for having great discomfort.

  4. Recurrence free survival [ Time Frame: 3-5 years ]
    Recurrence free survival for 3 years and 5 years, which means the rate of patients without local recurrence in the whole patients at the same group will be calculated with Kaplan Meier survival curves.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   up to 75 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Ability to understand the study procedures and contents, and willingness to voluntarily sign the written informed consent form;
  2. Age≤75 years old, female;
  3. Histologically confirmed breast cancer;
  4. Histologically or cytologically confirmed ipsilateral supraclavicular lymph node metastasis;
  5. cT0-T3;
  6. low and moderate risk for anesthesia

Exclusion Criteria:

  1. Absolute and relative contraindication for surgery or radiation;
  2. existing distant metastasis before surgery;
  3. non-invasive breast cancer;
  4. with contralateral breast cancer;
  5. Previous history of breast cancer or other malignancies;
  6. ECOG≥2;
  7. inflammatory breast cancer;
  8. pregnancy;
  9. any serious complications which caused patients not suitable to participate this study

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): NCT03716245


Contacts
Layout table for location contacts
Contact: Xinhong Wu, Doctor +8618602726300 34053889@qq.com
Contact: Hongmei Zheng, Doctor +8618971624606 18971624606@163.com

Locations
Layout table for location information
China, Hubei
Wu Xinhong Recruiting
Wuhan, Hubei, China, 430079
Contact: xinhong wu, dotcor    +8618602726300    369423971@qq.com   
Contact: hongmei zheng, doctor    +8618971624606    zhenghongmeicj@163.com   
Sponsors and Collaborators
Xinhong Wu
Investigators
Layout table for investigator information
Principal Investigator: Xinhong Wu, Doctor Hubei Cancer Hospital

Layout table for additonal information
Responsible Party: Xinhong Wu, vice-president, Hubei Cancer Hospital
ClinicalTrials.gov Identifier: NCT03716245    
Other Study ID Numbers: SCLND0919
First Posted: October 23, 2018    Key Record Dates
Last Update Posted: February 12, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Study Protocol Statistical Analysis Plan (SAP) Informed Consent Form (ICF) Clinical Study Report (CSR) Analytic Code
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Analytic Code
Time Frame: 3-5 years

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Xinhong Wu, Hubei Cancer Hospital:
breast cancer
supraclavicular lymph node
dissection
radiotherpy
prognosis
Additional relevant MeSH terms:
Layout table for MeSH terms
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases