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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2004 by National Cancer Institute (NCI).
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00002851
First received: November 1, 1999
Last updated: January 28, 2010
Last verified: December 2004

November 1, 1999
January 28, 2010
July 1996
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Complete list of historical versions of study NCT00002851 on ClinicalTrials.gov Archive Site
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Lymph Node Radiation Therapy in Patients With Stage I, Stage II, or Stage III Breast Cancer That Has Been Surgically Removed
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

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.

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.

Interventional
Phase 3
Allocation: Randomized
Primary Purpose: Treatment
Breast Cancer
  • Procedure: adjuvant therapy
  • Radiation: low-LET electron therapy
  • Radiation: low-LET photon therapy
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
4000
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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
Female
up to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
Belgium,   Bosnia and Herzegovina,   Chile,   France,   Germany,   Israel,   Italy,   Netherlands,   Poland,   Portugal,   Spain,   Switzerland,   Turkey,   United Kingdom
 
NCT00002851
CDR0000065094, EORTC-10925, EORTC-22922
Not Provided
Not Provided
European Organisation for Research and Treatment of Cancer - EORTC
Not Provided
Investigator: Walter F. Van den Bogaert, MD, PhD U.Z. Gasthuisberg
Investigator: H. Struikmans, MD, PhD Medisch Centrum Haaglanden Westeinde
Investigator: Alain Fourquet, MD Institut Curie
Investigator: Harry Bartelink, MD, PhD The Netherlands Cancer Institute
National Cancer Institute (NCI)
December 2004

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP