Medial vs. Entire Supraclavicular Lymph Node Radiation Therapy for Patients With Invasive Breast Cancer
NCT ID: NCT05059379
Last Updated: 2021-10-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
1650 participants
INTERVENTIONAL
2021-09-20
2027-08-31
Brief Summary
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Detailed Description
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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
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Breast/chest wall+undisseted axillary+IMN+medial SCL ( medial SCL radiation)
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.
Medial supraclavicular lymph node radiotherapy
Radiation is delivered to the breast/chest wall, undissected axilla, internal mammary nodes and entire supraclavicular lymph node.
Breast/chest wall+undisseted axillary+IMN+entie SCL (entire SCL radiation)
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.
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.
Interventions
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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.
Medial supraclavicular lymph node radiotherapy
Radiation is delivered to the breast/chest wall, undissected axilla, internal mammary nodes and entire supraclavicular lymph node.
Eligibility Criteria
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Inclusion Criteria
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
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
\-
18 Years
75 Years
FEMALE
No
Sponsors
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The First Affiliated Hospital of University of Science and Technology of China
OTHER
Quanzhou First Hospital
OTHER
Jiangyin People's Hospital
OTHER
Affiliated Hospital of Jiangnan University
OTHER
Guizhou Provincial People's Hospital
OTHER
Fudan University
OTHER
Responsible Party
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Principal Investigators
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Zhaozhi Yang, M.D
Role: PRINCIPAL_INVESTIGATOR
Fudan University
Xiaomao Guo
Role: STUDY_CHAIR
Fudan University
Locations
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Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, China
Countries
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Central Contacts
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Facility Contacts
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References
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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.
Other Identifiers
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FDRT-BC017
Identifier Type: -
Identifier Source: org_study_id