Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Published Results
Trial Contact Information
Registry Information

Alternate Title

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

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase III Treatment Closed 75 and under Other EORTC-10925 EORTC-22922, NCT00002851

Objectives

1. 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.

Entry 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

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

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

Expected Enrollment

A total of 4,000 patients will be accrued for this study within 4 years.

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.

Musat E, Poortmans P, Van den Bogaert W, et al.: Quality assurance in breast cancer: EORTC experiences in the phase III trial on irradiation of the internal mammary nodes. Eur J Cancer 43 (4): 718-24, 2007.[PUBMED Abstract]

Poortmans P, Kouloulias V, van Tienhoven G, et al.: 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 182 (10): 576-82, 2006.[PUBMED Abstract]

Poortmans P, Kouloulias VE, Venselaar JL, et al.: 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 39 (14): 2035-42, 2003.[PUBMED Abstract]

Poortmans PM, Venselaar JL, Struikmans H, et al.: 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 49 (5): 1399-408, 2001.[PUBMED Abstract]

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.

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.

Trial Contact Information

Trial Lead Organizations

European Organization for Research and Treatment of Cancer

Walter Van den Bogaert, MD, PhD, Study coordinator		Ph: 32-16-346-902 Email: walter.vandenbogaert@uz.kuleuven.ac.be
H. Struikmans, MD, PhD, Study coordinator		Ph: 31-70-330-2013 Email: h.struikmans@mchaaglanden.nl
Alain Fourquet, MD, Study coordinator		Ph: 1-4432-4631 Email: alain.fourquet@curie.net
Harry Bartelink, MD, PhD, Study coordinator		Ph: 31-20-512-2120

Registry Information
Official Title		PHASE III RANDOMISED TRIAL INVESTIGATING THE ROLE OF INTERNAL MAMMARY AND MEDIAL SUPRACLAVICULAR (IM-MS) LYMPH NODE CHAIN IRRADIATION IN STAGE I-III BREAST CANCER
Trial Start Date		1996-07-23
Registered in ClinicalTrials.gov		NCT00002851
Date Submitted to PDQ		1996-07-23
Information Last Verified		2004-12-02

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