Skip to content
Triangle logo TriangleGet started
← Study library

NCT00002851 · CITED IN SOURCE DOCUMENTS

Lymph Node Radiation Therapy in Patients With Stage I, Stage II, or Stage III Breast Cancer That Has Been Surgically Removed

An NCI or FDA source cites this study. A citation does not establish that it applies to an individual diagnosis.

Phase
PHASE3
Status at capture
UNKNOWN
Registry last update
2010-01-29

RATIONALE: Radiation therapy may kill any tumor cells remaining after surgery. PURPOSE: This randomized phase III trial is studying radiation therapy to see how well it works compared to no further therapy in treating women with stage I, stage II, or stage III breast cancer that has been surgically removed.

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

No posted result sections were captured. Registered plans do not establish that a treatment works.

Who could take part
eligibility Criteria
DISEASE CHARACTERISTICS: * Histologically confirmed unilateral adenocarcinoma of the breast * Stage I/II/III (Tx, T0-3, N0-2) disease in one of the following categories or multifocal tumors if one of the foci is in agreement with the following: * Centrally or medially located with any lymph node status * Central location defined as underlying the areola * Medial location defined as at least partial involvement of upper or lower medial quadrant of breast * Externally located with axillary node involvement * Prior mastectomy or breast-conserving surgery and axillary dissection required * Sentinel node procedure as axillary intervention without further axillary surgery is allowed * No prior internal mammary chain dissection * No upper inner lesion treated with breast-conserving surgery that precludes sparing of internal mammary lymph node chain from radiotherapy volume * Decision at radiation oncologist's discretion * Hormone receptor status: * Not specified PATIENT CHARACTERISTICS: Age: * 75 and under Sex: * Female Menopausal status: * Not specified Performance status: * Not specified Hematopoietic: * Not specified Hepatic: * Not specified Renal: * Not specified Cardiovascular: * No prior cardiac disease Other: * No prior malignancy except adequately treated nonmelanomatous skin cancer or carcinoma in situ of the cervix PRIOR CONCURRENT THERAPY: Biologic therapy: * Not specified Chemotherapy: * Not specified Endocrine therapy: * Not specified Radiotherapy: * Not specified Surgery: * See Disease Characteristics Other: * Concurrent enrollment in other randomized trials allowed
healthy Volunteers
false
maximum Age
75 Years
sex
FEMALE
std Ages
  1. CHILD
  2. ADULT
  3. OLDER_ADULT
Treatment arms and interventions
interventions
  1. name
    adjuvant therapy
    type
    PROCEDURE
  2. name
    low-LET electron therapy
    type
    RADIATION
  3. name
    low-LET photon therapy
    type
    RADIATION
Study design
allocation
RANDOMIZED
primary Purpose
TREATMENT
Enrollment
count
4000
type
ESTIMATED
Registered outcome plans (not posted results)
Full study description
brief Summary
RATIONALE: Radiation therapy may kill any tumor cells remaining after surgery. PURPOSE: This randomized phase III trial is studying radiation therapy to see how well it works compared to no further therapy in treating women with stage I, stage II, or stage III breast cancer that has been surgically removed.
detailed Description
OBJECTIVES: * Compare the effect of irradiation of the homolateral internal mammary and medial supraclavicular lymph node chains vs no further therapy on survival, disease-free survival, metastasis-free survival, and cause of death in women with resected stage I/II/III breast cancer. OUTLINE: This is a randomized, multicenter study. Patients are stratified by participating institution, tumor location, type of prior breast surgery, pathologic T and N stage, menopausal status, and time sequence of radiotherapy and adjuvant chemotherapy. Patients are randomized to 1 of 2 arms. * Arm I: Patients receive no nodal irradiation. * Arm II: Patients receive irradiation of the internal mammary and medial supraclavicular lymph node chains delivered at 1 fraction per day, 5 sessions per week, for a total of 25 fractions over 5 weeks. Radiotherapy must begin no later than 8 weeks after surgery. If adjuvant chemotherapy is given, radiotherapy begins within 6 weeks after the last course of chemotherapy and within 8 months after surgery. Patients are followed at least yearly after randomization for up to 20 years. PROJECTED ACCRUAL: A total of 4,000 patients will be accrued for this study within 4 years.
Source references
references
  1. citation
    Matzinger O, Heimsoth I, Poortmans P, Collette L, Struikmans H, Van Den Bogaert W, Fourquet A, Bartelink H, Ataman F, Gulyban A, Pierart M, Van Tienhoven G; EORTC Radiation Oncology & Breast Cancer Groups. Toxicity at three years with and without irradiation of the internal mammary and medial supraclavicular lymph node chain in stage I to III breast cancer (EORTC trial 22922/10925). Acta Oncol. 2010;49(1):24-34. doi: 10.3109/02841860903352959.
    pmid
    20100142
    type
    RESULT
  2. citation
    Musat E, Poortmans P, Van den Bogaert W, Struikmans H, Fourquet A, Bartelink H, Kirkove C, Budach V, Pierart M, Collette L. Quality assurance in breast cancer: EORTC experiences in the phase III trial on irradiation of the internal mammary nodes. Eur J Cancer. 2007 Mar;43(4):718-24. doi: 10.1016/j.ejca.2006.11.015. Epub 2007 Jan 19.
    pmid
    17240136
    type
    RESULT
  3. citation
    Poortmans P, Kouloulias V, van Tienhoven G, Collette L, Struikmans H, Venselaar JL, Van den Bogaert W, Davis JB, Lambin P; EORTC Radiation Oncology and Breast Cancer Groups. Quality assurance in the EORTC randomized trial 22922/10925 investigating the role of irradiation of the internal mammary and medial supraclavicular lymph node chain works. Strahlenther Onkol. 2006 Oct;182(10):576-82. doi: 10.1007/s00066-006-1629-2.
    pmid
    17013570
    type
    RESULT
  4. citation
    Poortmans P, Kouloulias VE, Venselaar JL, Struikmans H, Davis JB, Huyskens D, van Tienhoven G, Hurkmans C, Mijnheer B, Van den Bogaert W. Quality assurance of EORTC trial 22922/10925 investigating the role of internal mammary--medial supraclavicular irradiation in stage I-III breast cancer: the individual case review. Eur J Cancer. 2003 Sep;39(14):2035-42. doi: 10.1016/s0959-8049(03)00455-6.
    pmid
    12957458
    type
    RESULT
  5. citation
    Poortmans PM, Venselaar JL, Struikmans H, Hurkmans CW, Davis JB, Huyskens D, van Tienhoven G, Vlaun V, Lagendijk JJ, Mijnheer BJ, De Winter KA, Van der Hulst MH, Van den Bogaert WF. The potential impact of treatment variations on the results of radiotherapy of the internal mammary lymph node chain: a quality-assurance report on the dummy run of EORTC Phase III randomized trial 22922/10925 in Stage I--III breast cancer(1). Int J Radiat Oncol Biol Phys. 2001 Apr 1;49(5):1399-408. doi: 10.1016/s0360-3016(00)01549-2.
    pmid
    11286848
    type
    RESULT
  6. citation
    Poortmans P, Van Den Bogaert W, Venselaar J, et al.: Quality assurance in EORTC trial 22922/10925 concerning internal mammary chain (IMC) irradiation: the dummy run. Radiother Oncol 48(suppl 1): A735, s186, 1998.
    type
    RESULT
  7. citation
    Poortmans P, Van Den Bogaert W, Venselaar J, et al.: EORTC randomized phase III trials 22922/10925 investigating the role of internal mammary chain (IMC) irradiation in stage I-II breast cancer: a quality assurance report on the dummy run. Eur J Cancer 34(suppl 5): A257, s58, 1998.
    type
    RESULT
  8. citation
    Kaidar-Person O, Weltens CG, Fortpied C, Scheijmans LJEE, Kirkove CY, Budach V, Peignaux-Casasnovas K, Valli M, Peters M, van der Leij F, Rivera S, Weidner N, van den Bongard DHJG, Linsenmeier C, Abdah-Bortnyak R, Hosni S, Koiter E, Engelen AM, Baten A, Champezou L, Fourquet A, Bartelink HGMM, Struikmans H, Poortmans PMP; EORTC Radiation Oncology and Breast Cancer Groups. Internal mammary chain and medial supraclavicular lymph node irradiation in stage I-III breast cancer (EORTC trial 22922/10925): an unplanned subset analysis of 20-year outcomes in patients with node-negative breast cancer. Lancet Oncol. 2026 Jul;27(7):817-829. doi: 10.1016/S1470-2045(26)00233-0.
    pmid
    42372743
    type
    DERIVED
  9. citation
    Siman-Tov M, Ostrovski A, Mast M, Struikmans H, Bogers L, Fortpied C, Hol S, Petoukhova A, van Egmond J, Poortmans P, Kaidar-Person O. Dosimetric Analyses of the Three Radiation Techniques Used in the EORTC 22922/10925 IM-MS Breast Cancer Trial. Clin Oncol (R Coll Radiol). 2024 Nov;36(11):690-700. doi: 10.1016/j.clon.2024.08.012. Epub 2024 Aug 24.
    pmid
    39261237
    type
    DERIVED
  10. citation
    Kaidar-Person O, Fortpied C, Hol S, Weltens C, Kirkove C, Budach V, Peignaux-Casasnovas K, van der Leij F, Vonk E, Valli M, Weidner N, Guckenberger M, Koiter E, Fourquet A, Bartelink H, Struikmans H, Poortmans P; EORTC Radiation Oncology and Breast Cancer Groups. The association of internal mammary and medial supraclavicular lymph node radiation technique with clinical outcomes: Results from the EORTC 22922/10925 randomised trial. Radiother Oncol. 2022 Jul;172:99-110. doi: 10.1016/j.radonc.2022.05.006. Epub 2022 May 12.
    pmid
    35568284
    type
    DERIVED
  11. citation
    Poortmans PM, Struikmans H, De Brouwer P, Weltens C, Fortpied C, Kirkove C, Budach V, Peignaux-Casasnovas K, van der Leij F, Vonk E, Valli M, vanTienhoven G, Weidner N, Noel G, Guckenberger M, Koiter E, vanLimbergen E, Engelen A, Fourquet A, Bartelink H; EORTC Radiation Oncology and Breast Cancer Groups. Side Effects 15 Years After Lymph Node Irradiation in Breast Cancer: Randomized EORTC Trial 22922/10925. J Natl Cancer Inst. 2021 Oct 1;113(10):1360-1368. doi: 10.1093/jnci/djab113.
    pmid
    34320651
    type
    DERIVED
  12. citation
    Poortmans PM, Weltens C, Fortpied C, Kirkove C, Peignaux-Casasnovas K, Budach V, van der Leij F, Vonk E, Weidner N, Rivera S, van Tienhoven G, Fourquet A, Noel G, Valli M, Guckenberger M, Koiter E, Racadot S, Abdah-Bortnyak R, Van Limbergen EF, Engelen A, De Brouwer P, Struikmans H, Bartelink H; European Organisation for Research and Treatment of Cancer Radiation Oncology and Breast Cancer Groups. Internal mammary and medial supraclavicular lymph node chain irradiation in stage I-III breast cancer (EORTC 22922/10925): 15-year results of a randomised, phase 3 trial. Lancet Oncol. 2020 Dec;21(12):1602-1610. doi: 10.1016/S1470-2045(20)30472-1. Epub 2020 Nov 2.
    pmid
    33152277
    type
    DERIVED
Source notices and limitations
    Discovery and provenance
    1. release id
      ctgov-registry-7ad944f6deaf1f5cd6122126
      edge id
      nct-edge-5b29d68896853eb5af30
      requested nct id
      NCT00002851
      primary nct id
      NCT00002851
      source kind
      nci_explicit_reference_or_link
      source record id
      Source null
      source file sha256
      862f78faa9e4cbedc19f9ffcaeba97e029ba51b72bb3b81fc67aa8b6adf96904
      payload sha256
      e3588625020fcc37c731845315fdd29b689219dbe7c416de92df0f72e9daf066
      payload
      clinical indication matching status
      not_inferred
      end exclusive
      true
      id
      nct-edge-5b29d68896853eb5af30
      link basis
      explicit_NCT_identifier_in_acquired_source
      nct id
      NCT00002851
      occurrences
      1. context exact
        eturn(false);">Level of evidence A1</a>] </p> <p id="_3534" tabindex="-1">Similar findings were reported from the EORTC trial (<a href="/clinicaltrials/NCT00002851">NCT00002851</a>). Women with a centrally or medially located primary tumor with or without axillary node involvement, or an externally located tumor with axi
        end
        238159
        exact text
        NCT00002851
        start
        238148
      2. context exact
        ">Level of evidence A1</a>] </p> <p id="_3534" tabindex="-1">Similar findings were reported from the EORTC trial (<a href="/clinicaltrials/NCT00002851">NCT00002851</a>). Women with a centrally or medially located primary tumor with or without axillary node involvement, or an externally located tumor with axillary involve
        end
        238172
        exact text
        NCT00002851
        start
        238161
      offset unit
      unicode_code_points
      source file
      /tmp/cancer-full-research/nci/raw/29bf1e5a1d739974ed.html
      source file sha256
      862f78faa9e4cbedc19f9ffcaeba97e029ba51b72bb3b81fc67aa8b6adf96904
      source json pointer
      Source null
      source kind
      nci_explicit_reference_or_link
      source record id
      Source null
      source retrieved at
      2026-09-09T23:21:35.419733+00:00
      source string basis
      UTF-8_text_with_universal_newline_translation
      source string sha256
      536430925e3b0008edd3fb69a869d5645bd6b6dc5c84c21ddf1b3e24f089874c
      source title
      Breast Cancer Treatment (PDQ®)–Health Professional Version
      source update dates
      1. context
        Updated: April 25, 2025
        datetime
        2025-04-25T12:00:00Z
        display
        April 25, 2025

    Preserved source evidence · Not medical advice