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RecurIndex Guided Avoidance of Regional Nodal Irradiation for Node Positive Breast Cancer (RIGAIN)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04069884
Recruitment Status : Not yet recruiting
First Posted : August 28, 2019
Last Update Posted : August 28, 2019
Sponsor:
Collaborator:
Xiaobo Huang
Information provided by (Responsible Party):
Fengxi Su, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Brief Summary:
The study was divided into two randomized controlled trials. The purpose of this study is to validate whether clinically high-risk, and RecurIndex low-risk N1 patients omitting regional lymph node radiotherapy can do well with good prognosis, or whether clinically low-risk, and RecurIndex high-risk N1 patients receiving regional lymph node radiotherapy can further improve clinical outcomes.

Condition or disease Intervention/treatment Phase
Breast Cancer Radiation Radiation: regional nodal irradiation Radiation: WBI Radiation: chestwall XRT Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1834 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: RecurIndex Guided Avoidance of Regional Nodal Irradiation for Node Positive Breast Cancer
Estimated Study Start Date : August 20, 2019
Estimated Primary Completion Date : August 20, 2029
Estimated Study Completion Date : December 31, 2030

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arm Intervention/treatment
Active Comparator: Arm I (Clinical high-risk, RecurIndex low-risk)
Regional nodal irradiation (RNI) was given along with whole breast irradiation (WBI) or Chest wall irradiation (CWI) for breast-conserving patients and total mastectomy patients, respectively.
Radiation: regional nodal irradiation
external-beam radiotherapy (XRT)

Radiation: WBI
Whole Breast Irradiation

Radiation: chestwall XRT
chestwall irradiation

Experimental: Arm II (Clinical high-risk, RecurIndex low-risk)
No Regional nodal irradiation (RNI) , whole breast irradiation (WBI) for breast-conserving patients and No Chest wall irradiation (CWI) for total mastectomy patients.
Radiation: WBI
Whole Breast Irradiation

Active Comparator: Arm III (Clinical low-risk, RecurIndex high-risk)
No Regional nodal irradiation (RNI) , whole breast irradiation (WBI) for breast-conserving patients and No Chest wall irradiation (CWI) for total mastectomy patients.
Radiation: WBI
Whole Breast Irradiation

Experimental: Arm IV (Clinical low-risk, RecurIndex high-risk)
Regional nodal irradiation (RNI) was given along with whole breast irradiation (WBI) or Chest wall irradiation (CWI) for breast-conserving patients and total mastectomy patients, respectively.
Radiation: regional nodal irradiation
external-beam radiotherapy (XRT)

Radiation: WBI
Whole Breast Irradiation

Radiation: chestwall XRT
chestwall irradiation




Primary Outcome Measures :
  1. Invasive disease-free survival (IDFS) [ Time Frame: 5 years ]
    defined as the time between randomization and either local recur, distant metastases or death occurred


Secondary Outcome Measures :
  1. Any first recurrence (AFR) [ Time Frame: 5 years ]
    defined as any recurrence of ipsilateral chest, breast, regional lymph node recurrence, or distant metastases by Imaging or pathology

  2. Local-regional recurrence free survival (LRFS) [ Time Frame: 5 years ]
    defined as time between randomization and the time of any recurrence of ipsilateral chest, breast, regional lymph node recurrence, distant metastases, or death occurred

  3. Distant metastasis free survival (DMFS) [ Time Frame: 5 years ]
    defined as time between randomization and the time of distant metastases, or death occurred

  4. Recurrence free survival (RFS) [ Time Frame: 5 years ]
    defined as time between randomization and the time of any recurrence of ipsilateral chest, breast, regional lymph node recurrence, distant metastases, or death occurred

  5. Overall Survival (OS) [ Time Frame: 5 years ]
    defined as time between randomization and the time of death occurred

  6. Disease free survival (DFS) [ Time Frame: 5 years ]
    defined as time between randomization and the time of disease recur or death occur

  7. Beast cancer specific mortality (BCSM) [ Time Frame: 5 years ]
    defined as time between randomization and the time of death occur specific due to breast cancer

  8. Patient life quality measurement [ Time Frame: 5 years ]
    At the screening period and after the end of radiotherapy, each group of patients was enrolled in the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ) Cancer-30 (C30)

  9. Patient life quality measurement [ Time Frame: 5 years ]
    At the screening period and after the end of radiotherapy, each group of patients was enrolled in the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ) Breast-23 (BR23)



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age ≥ 18 years old, ≤ 70 years old.
  • Eastern Cooperative Oncology Group (ECOG) ≤ 2.
  • Postoperative pathology is clearly diagnosed as invasive breast cancer.
  • Postoperative pathological diagnosis of axillary lymph node status is any of the following: a. Sentinel lymph node biopsy or axillary lymph node dissection for micrometastasis (N1mic), b. Sentinel lymph node biopsy for 1-2 lymph node macrometastasis (N1sln), c. Sentinel lymph node biopsy + axillary lymph node dissection or simple axillary lymph node dissection for 1-3 lymph node metastasis (N1).
  • The primary tumor and breast undergo breast-conserving surgery or total resection ± breast reconstruction (autologous/prosthetic).
  • There must be adequate systemic examination (such as chest X-ray, B-ultrasound, CT, etc.) within 3 months before randomization of radiotherapy to confirm that there is no distant metastasis.
  • Preoperative or radiotherapy should be performed within 12 months of randomization and must have mammography and/or MRI to confirm that there is no contralateral breast cancer.
  • At least 4 courses of adjuvant chemotherapy with anthracycline or taxane should be completed after surgery.
  • Radiotherapy must be performed sequentially after the completion of adjuvant chemotherapy, starting no later than 8 weeks after the end of chemotherapy.
  • The patient must have sufficient primary fresh frozen specimens or post-paraffin tissue sections for RecurIndex testing.
  • No previous history of malignant tumors, except for basal cell carcinoma of the skin.
  • Signed an informed consent form.

Exclusion Criteria:

  • Postoperative radiotherapy was confirmed as T3-4, N0, N2-3, M1 lesion staging before enrollment.
  • Receive any new adjuvant therapy before surgery, including chemotherapy, endocrine therapy, targeted therapy or radiation therapy.
  • Patients who underwent total mastectomy and only sentinel lymph node biopsy.
  • Have a history of contralateral breast cancer.
  • History of chest radiotherapy.
  • combined with severe heart, lung, liver, kidney, hematopoietic, neurological diseases, and mental illness.
  • History of autoimmune diseases such as scleroderma or active lupus erythematosus.
  • pregnant and lactating patients.
  • Unable or unwilling to sign an informed consent form.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04069884


Contacts
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Contact: Xiaobo Huang, MD 8613556080080 huangxb@mail.sysu.edu.cn
Contact: Tan Yuting 8615913198466 tanyt3@mail.sysu.edu.cn

Locations
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China, Guangdong
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Guangzhou, Guangdong, China, 510120
Contact: Xiaobo Y Huang, MD    8613556080080 ext 8613556080080    huangxb@mail.sysu.edu.cn   
Contact: Yuting Y Tan    8615913198466 ext 8613556080080    tanyt3@mail.sysu.edu.cn   
Principal Investigator: Xiaobo Huang, MD         
Sub-Investigator: Yuting Tan         
Sub-Investigator: Fengxi Su, MD         
Sponsors and Collaborators
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Xiaobo Huang
Publications of Results:

Other Publications:
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Responsible Party: Fengxi Su, Head of Breast Surgery, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
ClinicalTrials.gov Identifier: NCT04069884    
Other Study ID Numbers: RIGAIN
First Posted: August 28, 2019    Key Record Dates
Last Update Posted: August 28, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: individual patient data (IPD) will be shared when the research is published.
Supporting Materials: Study Protocol
Time Frame: The data will become available in 2030 and forever.
Access Criteria: Study Protocol

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases