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

Primary Purpose

Breast Cancer, Radiotherapy; Complications, Effect of Radiation Therapy

Status
Recruiting
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
Entire supraclavicular lymph node radiotherapy
Medial supraclavicular lymph node radiotherapy
Sponsored by
Fudan University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Breast Cancer focused on measuring breast cancer, supraclavicular lymph node, radiotherapy

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  1. ECOG 0-1
  2. Newly diagnosed invasive breast cancer
  3. 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.
  4. 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.
  5. Should receive ≥6 cycles standard neoadjuvant and/or adjuvant chemotherapy (taxane and/or anthracycline based).
  6. 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.
  7. 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.
  8. Writtern, informed consent.

Exclusion Criteria:

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

    -

Sites / Locations

  • Fudan University Shanghai Cancer CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Breast/chest wall+undisseted axillary+IMN+medial SCL ( medial SCL radiation)

Breast/chest wall+undisseted axillary+IMN+entie SCL (entire SCL radiation)

Arm Description

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.

Outcomes

Primary Outcome Measures

Disease free survival (DFS )
defined as time from randomization until to local, regional, or distant recurrence, or any death, or secondary primary cancer

Secondary Outcome Measures

Overall survival (OS)
defined as time from any death
Ipsilateral supraclavicular lymph node recurrence (ISLNR) )
defined as entire ipsilateral supraclavicular lymph node recurrence
Local reigonal recurrence (LRR)
chest wall, breast , regional lymph node recurrence
Distance metastasis (DS)
any recurrence in all areas beyond local, regional and death due to breast cancer
incidence of adverse events
Adverse events categorized using the NCI Common Terminology for Adverse Events Version 4.0 (CTCAE v4.0)
difference of quality of life
evaluate the quality of life according to EROTC-QLQ-C30 and QLQ BR23
differences in upper limb function
evaluate the upper limb function by Quick-dash

Full Information

First Posted
September 10, 2021
Last Updated
October 17, 2021
Sponsor
Fudan University
Collaborators
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
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1. Study Identification

Unique Protocol Identification Number
NCT05059379
Brief Title
Medial vs. Entire Supraclavicular Lymph Node Radiation Therapy for Patients With Invasive Breast Cancer
Acronym
SUCLANODE
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2021
Overall Recruitment Status
Recruiting
Study Start Date
September 20, 2021 (Actual)
Primary Completion Date
August 2026 (Anticipated)
Study Completion Date
August 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fudan University
Collaborators
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

4. Oversight

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

5. Study Description

Brief Summary
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer, Radiotherapy; Complications, Effect of Radiation Therapy
Keywords
breast cancer, supraclavicular lymph node, radiotherapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1650 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Breast/chest wall+undisseted axillary+IMN+medial SCL ( medial SCL radiation)
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Breast/chest wall+undisseted axillary+IMN+entie SCL (entire SCL radiation)
Arm Type
Experimental
Arm Description
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.
Intervention Type
Radiation
Intervention Name(s)
Entire supraclavicular lymph node radiotherapy
Intervention Description
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.
Intervention Type
Radiation
Intervention Name(s)
Medial supraclavicular lymph node radiotherapy
Intervention Description
Radiation is delivered to the breast/chest wall, undissected axilla, internal mammary nodes and entire supraclavicular lymph node.
Primary Outcome Measure Information:
Title
Disease free survival (DFS )
Description
defined as time from randomization until to local, regional, or distant recurrence, or any death, or secondary primary cancer
Time Frame
Up to 5 years after completion of radiation therapy
Secondary Outcome Measure Information:
Title
Overall survival (OS)
Description
defined as time from any death
Time Frame
Up to 5 years after completion of radiation therapy
Title
Ipsilateral supraclavicular lymph node recurrence (ISLNR) )
Description
defined as entire ipsilateral supraclavicular lymph node recurrence
Time Frame
Up to 5 years after completion of radiation therapy
Title
Local reigonal recurrence (LRR)
Description
chest wall, breast , regional lymph node recurrence
Time Frame
Up to 5 years after completion of radiation therapy
Title
Distance metastasis (DS)
Description
any recurrence in all areas beyond local, regional and death due to breast cancer
Time Frame
Up to 5 years after completion of radiation therapy
Title
incidence of adverse events
Description
Adverse events categorized using the NCI Common Terminology for Adverse Events Version 4.0 (CTCAE v4.0)
Time Frame
Up to 5 years after completion of radiation therapy
Title
difference of quality of life
Description
evaluate the quality of life according to EROTC-QLQ-C30 and QLQ BR23
Time Frame
Up to 5 years after completion of radiation therapy
Title
differences in upper limb function
Description
evaluate the upper limb function by Quick-dash
Time Frame
Up to 5 years after completion of radiation therapy

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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 -
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Zhaozhi Yang, M.D.
Phone
86 18017317126
Email
yzzhi2014@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zhaozhi Yang, M.D
Organizational Affiliation
Fudan University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Xiaomao Guo
Organizational Affiliation
Fudan University
Official's Role
Study Chair
Facility Information:
Facility Name
Fudan University Shanghai Cancer Center
City
Shanghai
State/Province
Shanghai
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zhaozhi C Yang
Phone
+8618017317126
Email
yzzhi2014@163.com

12. IPD Sharing Statement

Plan to Share IPD
No

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

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