Clinical Significance of Supraclavicular Lymph Node Dissection for Breast Cancer

NCT ID: NCT03716245

Last Updated: 2024-01-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 180 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-02-27
• Study Completion Date: 2024-01-20

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.

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.

Conditions

Breast Cancer Stage III

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

supraclavicular lymph node dissection and raidiotherapy

breast cancer patients with supraclavicular lymph node metastasis receive supraclavicular lymph node dissection and supraclavicular area radiotherapy

Group Type: EXPERIMENTAL

supraclavicular lymph node dissection

Intervention Type: PROCEDURE

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

supraclavicular area radiotherapy

breast cancer patients with supraclavicular lymph node metastasis receive supraclavicular area radiotherapy

Group Type: ACTIVE_COMPARATOR

supraclavicular area radiotherapy

Intervention Type: RADIATION

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

Interventions

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

Intervention Type: PROCEDURE

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

Intervention Type: RADIATION

Eligibility 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

• Maximum Eligible Age: 75 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Xinhong Wu, PhD

OTHER

Sponsor Role: lead

Responsible Party

Xinhong Wu, PhD

vice-president

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Xinhong Wu, Doctor

Role: PRINCIPAL_INVESTIGATOR

Hubei Cancer Hospital

Locations

Wu Xinhong

Wuhan, Hubei, China

Countries

China

Other Identifiers

SCLND0919

Identifier Type: -

Identifier Source: org_study_id