Neoplasms

Symptoms and General Pathology

All Conditions

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Gland and Hormone Related Diseases

Rare Diseases

Neoplasm Metastasis

Ovarian Neoplasms

Carcinoma, Ovarian Epithelial

Carcinoma

Lymphatic Metastasis

Neoplastic Processes

Endocrine Gland Neoplasms

Ovarian Diseases

Adnexal Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Genital Neoplasms, Female

Urogenital Neoplasms

Endocrine System Diseases

Gonadal Disorders

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Ovarian Cancer

Ovarian Epithelial Cancer

debulking surgery as primary debulking surgery or interval debulking surgery

debulking surgery

Hee Seung Kim, Pf

To evaluate the survival impact of extensive lymphadenectomy as part of debulking surgery in stage IVB ovarian cancer with supradiaphragmatic lymph node metastasis.

Survival Impact of Internal Mammary or Supraclavicular Lymphadenectomy

Survival Impact of Internal Mammary or Supraclavicular Lymphadenectomy on Stage IVB Ovarian Cancer With Supradiaphragmatic Lymph Node Metastasis

the time interval from the treatment start date to disease recurrence or progression date

the time interval from the treatment start date to death or end of study date

Seoul National University Hospital

Associate Professor

Skin and Connective Tissue Diseases

Breast Neoplasms

Recurrence

Breast Diseases

Skin Diseases

Radiation is delivered to the breast/chest wall, undissected axilla, internal mammary nodes and medial supraclavicular node. Treatment will be given by normfractionated or hypofractionated radiotherapy (50Gy/25Fx/5w or 42.5Gy/16Fx/3.5w). IMRT and VMAT technique are recommended.

Radiation is delivered to the breast/chest wall, undissected axilla, internal mammary nodes and entire supraclavicular node. Treatment will be given by normfractionated or hypofractionated radiotherapy (50Gy/25Fx/5w or 42.5Gy/16Fx/3.5w). IMRT and VMAT technique are recommended.

Radiation is delivered to the breast/chest wall, undissected axilla, internal mammary nodes and entire supraclavicular lymph node. Entire supraclavicular lymph node includes medial supraclavicular and posterior neck lymph node.

Entire supraclavicular lymph node radiotherapy

Radiation is delivered to the breast/chest wall, undissected axilla, internal mammary nodes and entire supraclavicular lymph node.

Medial supraclavicular lymph node radiotherapy

Zhaozhi Yang, M.D.

Zhaozhi C Yang

Zhaozhi Yang, M.D

Xiaomao Guo

Locally advanced breast cancer has high-risk local regional recurrence after surgery. Radiotherapy could reduce the local regional recurrence and improve disease free survival and overall survival. Regional lymph node irradiation is the important part of breast cancer radiotherapy. However, there are some controversies about regional lymph node delineation, especially the supraclavicular irradiation volume. Many studies had confirmed that posterolateral region of the supraclavicular fossa (also named Posterior neck lymph node) had a high risk involvement based on the mapping of recurrence nodes. This randomized phase III trial compares medial supraclavicular lymph node irradiation with entire supraclavicular lymph node irradiation in patients with pathologically positive axillary lymph node and high risk of recurrence after mastectomy or breast conservative surgery. It is not yet known if radiation works better with entire supraclavicular fossa than medial supraclavicular fossa.

PRIMARY OBJIECTIVE:

I. To evaluate whether entire supraclavicular lymph node irradiation is superior to medial supraclavicular lymph node irradiation in terms of disease free survival for patients with positive lymph nodes and high risk of recurrence after breast cancer surgery

SECONDARY OBJECTIVES:

I. To estimate the difference of overall survival II. to estimate the difference of ipsilateral supraclavicular node recurrence III. to estimate the difference of local regional recurrence IV. to estimate the difference of radiation related toxicities and quality of life.

Outline: Beginning 2-12 weeks after the completion of breast cancer surgery and neoadjuvant/adjuvant chemotherapy, patients are randomized to 1 of 2 treatment arms Arm I: Patients undergo breast/chest wall, undissected axillary, internal mammary node and medial supraclavicular node radiation. Conventional fractionated radiotherapy 50Gy/25Fx/5w or hypofractionated 42.5Gy/16Fx/3.5week with IMRT or VAMT technique is recommended. 3DCRT technique is not permitted.

Arm II: Patients undergo breast/chest wall, undissected axillary, internal mammary node and entire supraclavicular node radiation. Conventional fractionated radiotherapy 50Gy/25Fx/5w or hypofractionated 42.5Gy/16Fx/3.5week with IMRT or VAMT technique is recommended. 3DCRT technique is not permitted

Medial vs. Entire Supraclavicular Lymph Node Radiation Therapy for Patients With Invasive Breast Cancer

A Multicenter Randomized Controlled Phase III Study of Medial vs. Entire Supraclavicualr Lymph Node Radiation Therapy for Patients With Pathologically Positive Axillary Lymph Node and High Risk of Recurrence After Breast Cancer Surgery

defined as time from randomization until to local, regional, or distant recurrence, or any death, or secondary primary cancer

defined as entire ipsilateral supraclavicular lymph node recurrence

chest wall, breast , regional lymph node recurrence

any recurrence in all areas beyond local, regional and death due to breast cancer

Adverse events categorized using the NCI Common Terminology for Adverse Events Version 4.0 (CTCAE v4.0)

evaluate the quality of life according to EROTC-QLQ-C30 and QLQ BR23

evaluate the upper limb function by Quick-dash

The First Affiliated Hospital of University of Science and Technology of China

Quanzhou First Hospital

Jiangyin People's Hospital

Affiliated Hospital of Jiangnan University

Guizhou Provincial People's Hospital

Fudan University

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

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

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 lymph node dissection

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

supraclavicular area radiotherapy

Xinhong Wu, Doctor

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.

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.

Clinical Significance of Supraclavicular Lymph Node Dissection for Breast Cancer

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

Study Protocol Statistical Analysis Plan (SAP) Informed Consent Form (ICF) Clinical Study Report (CSR) Analytic Code

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.

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.

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.

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.

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.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Survival Impact of Internal Mammary or Supraclavicular Lymphadenectomy	NCT05005650	Ovarian Cancer ... Lymph Node Meta...	debulking surge...	18 Years - 90 Years	Seoul National University Hospital
Medial vs. Entire Supraclavicular Lymph Node Radiation Therapy for Patients With Invasive Breast Cancer	NCT05059379	Breast Cancer Radiotherapy; C... Effect of Radia...	Entire supracla... Medial supracla...	18 Years - 75 Years	Fudan University
Clinical Significance of Supraclavicular Lymph Node Dissection for Breast Cancer	NCT03716245	Breast Cancer S...	supraclavicular... supraclavicular...	- 75 Years	Hubei Cancer Hospital
Medial vs. Entire Supraclavicular Lymph Node Radiation Therapy for Patients With Invasive Breast Cancer	NCT05059379	Breast Cancer Radiotherapy; C... Effect of Radia...	Entire supracla... Medial supracla...	18 Years - 75 Years	Fudan University
Survival Impact of Internal Mammary or Supraclavicular Lymphadenectomy	NCT05005650	Ovarian Cancer ... Lymph Node Meta...	debulking surge...	18 Years - 90 Years	Seoul National University Hospital

Spots Global Cancer Trial Database for supraclavicular lymph node