Menu
Recruiting NCT05059379

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

Phase III Interventional Breast Cancer Radiotherapy; Complications Effect of Radiation Therapy

For patients and families

In plain language

Fill the application

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Entire supraclavicular lymph node radiotherapy, Medial supraclavicular lymph node radiotherapy.
Who it may be relevant to
Registry conditions: Breast Cancer, Radiotherapy; Complications, Effect of Radiation Therapy. Basic parameters: 18 years — 75 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Detailed description

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

Interventions

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

Primary outcome measures

  • Disease free survival (DFS ) [Time frame: Up to 5 years after completion of radiation therapy]
Secondary outcome measures (7)
  • Overall survival (OS) [Time frame: Up to 5 years after completion of radiation therapy]
  • Ipsilateral supraclavicular lymph node recurrence (ISLNR) ) [Time frame: Up to 5 years after completion of radiation therapy]
  • Local reigonal recurrence (LRR) [Time frame: Up to 5 years after completion of radiation therapy]
  • Distance metastasis (DS) [Time frame: Up to 5 years after completion of radiation therapy]
  • incidence of adverse events [Time frame: Up to 5 years after completion of radiation therapy]
  • difference of quality of life [Time frame: Up to 5 years after completion of radiation therapy]
  • differences in upper limb function [Time frame: Up to 5 years after completion of radiation therapy]

Eligibility criteria

Inclusion criteria

  • ECOG 0-1
  • Newly diagnosed invasive breast cancer
  • Initial clincial diagonosis stage is T1-4, N0-3a/b, M0: If neoadjuvant chemotherapy was not administered: pathological stage is T1-3N2-3a/b, M0; If neoadjuvant chemotherapy was administered：clinical stage III or pathological stage is T1-4N1-3a/bM0.
  • Underwent breast conservative surgery or Mastectomy with or without breast reconstruction with clear negative margin. At least, axillary level I and level II should be cleared with ≥10 lymph node (including the number of sentinal lymph node) . Level III dissection and internal mamamry node dissection are not required, but may be performed at the discretion of the surgeon.
  • Should receive ≥6 cycles standard neoadjuvant and/or adjuvant chemotherapy (taxane and/or anthracycline based).
  • Enrolled on the trial within 12 weeks of the later of two dates: the final breast cancer surgical procedure or administration of the last cycle of cytotoxic chemotherapy.
  • For ER and/or PR positive patients, the duration of anticipated endocrine therapy should be≥5 year ; For HER2 postive patients, the duration of anticipated herceptin should be 1 year.
  • Writtern, informed consent.

Exclusion criteria

  • Initinal clinical diagnosis N3c (supraclavicualr node metastasis)
  • T4 or inflamed breast cancer with no good downstage by neoadjuvant chemotherapy
  • Distant metastasis
  • Bilateral breast cancer or previously contralateral breast cancer
  • Positve sentinal lymph node with no axillary dissection
  • ECOG ≥2
  • Could not tolerate chemotherapy and anti-HER2 target treatment
  • Active infectious
  • History of radiotherapy
  • Serious medical complcation
  • Breast cancer during pregnancy and lactation
  • Had simultaneousl or previous secondary malignancies, except for skin basal cell carcinoma and cervical carcinoma in situ.
  • Inaccessibility for follow-up

\-

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

China · 1 center
  • Fudan University Shanghai Cancer Center — Shanghai

Publications

  • Zhang L, Mei X, Hu Z, Yu B, Zhang C, Li Y, Liu K, Ma X, Ma J, Chen X, Meng J, Shi W, Wang X, Mo M, Shao Z, Zhang Z, Yu X, Guo X, Yang Z. Adjuvant medial versus entire supraclavicular lymph node irradiation in high-risk early breast cancer (SUCLANODE): a protocol for a multicenter, randomized, open-label, phase 3 trial. BMC Cancer. 2024 Jan 9;24(1):49. doi: 10.1186/s12885-024-11831-8. PMID 38195438

Identifiers

NCT: NCT05059379 · FDRT-BC017

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗