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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

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:

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
-

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

NCT ID

NCT05059379

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

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

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

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

Arm Title

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

Arm Type

Experimental

Arm Description

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

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

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

yzzhi2014@163.com

12. IPD Sharing Statement

Plan to Share IPD

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

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