UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000021016 |
|---|---|
| Receipt number | R000024252 |
| Scientific Title | A Randomized Phase III Clinical Trial Evaluating Post-Mastectomy Chestwall and Regional Nodal XRT and Post-Lumpectomy Regional Nodal XRT in Patients with Positive Axillary Nodes Before Neoadjuvant Chemotherapy Who Convert to Pathologically Negative Axillary Nodes After Neoadjuvant Chemotherapy |
| Date of disclosure of the study information | 2016/02/15 |
| Last modified on | 2024/04/05 19:43:28 |
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Basic information
Public title
A Randomized Phase III Clinical Trial Evaluating Post-Mastectomy Chestwall and Regional Nodal XRT and Post-Lumpectomy Regional Nodal XRT in Patients with Positive Axillary Nodes Before Neoadjuvant Chemotherapy Who Convert to Pathologically Negative Axillary Nodes After Neoadjuvant Chemotherapy
Acronym
NRG ONCOLOGY NSABP B-51/RTOG 1304
A Randomized Phase 3 Clinical Trial Evaluating Regional Nodal XRT in Patients Who Convert to Pathologically Negative Axillary Nodes After Neoadjuvant Chemotherapy
Scientific Title
A Randomized Phase III Clinical Trial Evaluating Post-Mastectomy Chestwall and Regional Nodal XRT and Post-Lumpectomy Regional Nodal XRT in Patients with Positive Axillary Nodes Before Neoadjuvant Chemotherapy Who Convert to Pathologically Negative Axillary Nodes After Neoadjuvant Chemotherapy
Scientific Title:Acronym
NRG ONCOLOGY NSABP B-51/RTOG 1304
A Randomized Phase 3 Clinical Trial Evaluating Regional Nodal XRT in Patients Who Convert to Pathologically Negative Axillary Nodes After Neoadjuvant Chemotherapy
Region
| Japan | Asia(except Japan) | North America |
| Europe |
Condition
Condition
Breast cancer
Classification by specialty
| Breast surgery | Radiology |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
To evaluate whether the addition of chestwall + regional nodal XRT after mastectomy or breast + regional nodal XRT after breast conserving surgery will significantly reduce the rate of events for invasive breast cancer recurrence-free interval (IBC-RFI) in patients who present with histologically positive axillary nodes but convert to histologically negative axillary nodes following neoadjuvant chemotherapy.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Phase III
Assessment
Primary outcomes
IBC-RFI
Key secondary outcomes
OS,LRRFI,DRFI,DFS-DCIS,Second primary invasive cancer,Quality of life,Toxicity,
Treatment adequacy,Effect of XRT,Molecular predictors of recurrence
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is considered as adjustment factor in dynamic allocation.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
4
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
Arm 1/Group 1A
Patients who had a lumpectomy and are randomized to Arm 1/Group 1A will receive standard whole breast XRT as outlined in Section 10.0 and any additional systemic therapy as planned(i.e., hormonal therapy for patients with hormone receptor-positive breast cancer and anti-HER2 therapy for patients with breast cancer that is HER2-positive)
Interventions/Control_2
Arm 1/Group 1B
Patients who had a mastectomy and are randomized to Arm 1/Group 1B will not receive XRT but will receive any additional systemic therapy as planned (i.e., hormonal therapy for patients with hormone receptor-positive breast cancer and anti-HER2 therapy for patients with breast cancer that is HER2-positive).
Interventions/Control_3
Arm 2/Group 2A
Patients who had a lumpectomy and are randomized to Arm 2/Group 2A will receive comprehensive XRT, which is XRT to the breast plus regional nodal areas and any additional systemic therapy as planned (i.e., hormonal therapy for patients with hormone receptor-positive breast cancer and anti-HER2 therapy for patients with breast cancer that is HER2-positive).
Interventions/Control_4
Arm 2/Group 2B
Patients who had a mastectomy and are randomized to Arm 2/Group 2B will receive comprehensive XRT, which is XRT to the chestwall plus regional nodal areas in addition to any additional systemic therapy as planned (i.e., hormonal therapy for patients with hormone receptor-positive breast cancer and anti-HER2 therapy for patients with breast cancer that is HER2-positive).
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Female
Key inclusion criteria
1) Female.
2) <=18 years old.
3)ECOG score:0-1
4) Clinically T1-3, N1 breast cancer at the time of diagnosis .
5)Pathologic confirmation of axillary nodal involvement at presentation based on either a positive FNA or positive core needle biopsy .
6) ER analysis performed on the primary breast tumor before neoadjuvant therapy according to current ASCO/CAP Guideline Recommendations for hormone receptor testing
7) ER analysis performed on the primary breast tumor before
neoadjuvant therapy according to current ASCO/CAP Guideline
8) Completed a minimum of 12 weeks of standard neoadjuvant chemotherapy consisting of an anthracycline and/or taxane-based regimen.
9) Completed a minimum of 12 weeks of standard neoadjuvant chemotherapy consisting of an anthracycline and/or taxane-based regimen.
10) HER2-positive tumors must have received neoadjuvant anti-HER2 therapy
11) At the time of definitive surgery, all removed axillary nodes must be histologically free from cancer.
12) Pathologic staging of ypN0(i+) or ypN0(mol+)
13)Undergone either a total mastectomy or a lumpectomy
14) For patients who undergo lumpectomy, the margins of the resected specimen or reexcision
must be histologically free of invasive tumor and DCIS.
15) For patients who undergo mastectomy, the margins must be histologically free of residual tumor.
16) The interval between the last surgery for breast cancer and randomization must be no more than 70 days. Also, if adjuvant chemotherapy was administered, the interval between the last chemotherapy treatment and randomization must be no more than 70 days.
17) Recovered from surgery with the incision completely healed and no signs of infection.
18) If adjuvant chemotherapy was administered, chemotherapy-related toxicity that may interfere with delivery of radiation therapy should have resolved.
Key exclusion criteria
1) Definitive clinical or radiologic evidence of metastatic disease.
2) T4 tumors including inflammatory breast cancer.
3) Documentation of axillary nodal positivity before neoadjuvant therapy by sentinel node biopsy alone.
4) N2 or N3 disease detected clinically or by imaging.
5 Histologically positive axillary nodes post neoadjuvant therapy.
6)Microscopic positive margins after definitive surgery.
7) Synchronous or previous contralateral invasive breast cancer or DCIS.
8) Any prior history, not including the index cancer, of ipsilateral invasive breast cancer or ipsilateral DCIS treated with radiation therapy
9) History of non-breast malignancies within 5 years prior to randomization.
10) Any radiation therapy for the currently diagnosed breast cancer prior to randomization.
11) Any continued use of sex hormonal therapy, e.g., birth control pills, ovarian hormone replacement therapy.
12) Prior breast or thoracic RT for any condition.
13) Active collagen vascular disease,specifically dermatomyositis with a CPK level above normal or with an active skin rash, systemic lupus erythematosis, or scleroderma.
14) Pregnancy or lactation at the time of study entry
15) Other non-malignant systemic disease that would preclude the patientfrom receiving study treatment or would prevent required follow-up.
16)Psychiatric or addictive disorders or other conditions that, in the opinion of the investigator, would preclude the patient from meeting the studyrequirements.
Target sample size
1636
Research contact person
Name of lead principal investigator
| 1st name | Norman |
| Middle name | |
| Last name | Wolmark |
Organization
NRG Oncology
Division name
NSABP
Zip code
15212-5402
Address
Nova Tower2 Two Allegheny Center -Suite 1200 Pittsburgh, PA 15212, USA
TEL
+1-800-477-7227
ccdpgh@nrgoncology.org
Public contact
Name of contact person
| 1st name | Masahiko |
| Middle name | |
| Last name | Okamoto |
Organization
Gunma University Hospital
Division name
Department of Radiology
Zip code
371-8511
Address
3-39-22 Showa-machi, Maebashi City, Gunma
TEL
027-220-8383
Homepage URL
nrg-japan@kuhs.ac.jp
Sponsor or person
Institute
NRG Oncology
Institute
Department
Personal name
Funding Source
Organization
National Cancer Institute (NCI)
Organization
Division
Category of Funding Organization
Outside Japan
Nationality of Funding Organization
U.S.A.
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
1. Gunma University Hospital Clinical Research Review Board 2. Hyogo Cancer Ceter Clinical Trial Management Department
Address
1. 3-39-15 Showacho, Maebashi City, Gunma Prefecture, Japan 2. 13-70 Kitaojicho, Akashi City, Hyogo Prefecture, Japan
Tel
1. 81-27-220-8383 2. 81-78-929-1151
1. gunmaciru-office@umin.ac.jp 2. hcc-irb@hyogo-cc.jp
Secondary IDs
Secondary IDs
YES
Study ID_1
NCT01872975
Org. issuing International ID_1
National Cancer Institute (NCI)
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
埼玉医科大学国際医療センター（埼玉県）、兵庫県立がんセンター（兵庫県）、群馬大学医学部附属病院（群馬県)、独立行政法人国立病院機構 四国がんセンター（愛媛県)、国立研究開発法人 国立がん研究センター中央病院（東京都）、北海道大学病院（北海道）、東北大学病院（宮城県）、新潟大学医歯学総合病院（新潟県）、鹿児島市立病院（鹿児島県）、岩手医科大学附属病院（岩手県）
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 02 | Month | 15 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
No longer recruiting
Date of protocol fixation
| 2016 | Year | 08 | Month | 18 | Day |
Date of IRB
| 2015 | Year | 09 | Month | 25 | Day |
Anticipated trial start date
| 2016 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2030 | Year | 10 | Month | 15 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 02 | Month | 14 | Day |
Last modified on
| 2024 | Year | 04 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024252
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