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
Recruitment status was Active, not recruiting
Sponsor:
European Organisation for Research and Treatment of Cancer - EORTC
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
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Breast Cancer |
Procedure: adjuvant therapy Radiation: low-LET electron therapy Radiation: low-LET photon therapy |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Primary Purpose: Treatment |
| 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 |
Resource links provided by NLM:
Further study details as provided by National Cancer Institute (NCI):
| Estimated Enrollment: | 4000 |
| Study Start Date: | July 1996 |
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.
Eligibility| Ages Eligible for Study: | up to 75 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00002851
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Hide Study LocationsLocations
| Belgium | |
| Ziekenhuis Network Antwerpen Middelheim | |
| Antwerp, Belgium, 2020 | |
| Cliniques Universitaires Saint-Luc | |
| Brussels, Belgium, 1200 | |
| Hopital de Jolimont | |
| Haine Saint Paul, Belgium, 7100 | |
| Cazk Groeninghe - Campus Maria's Voorzienigheid | |
| Kortrijk, Belgium, B-8500 | |
| U.Z. Gasthuisberg | |
| Leuven, Belgium, B-3000 | |
| Algemeen Ziekenhuis Sint-Augustinus | |
| Wilrijk, Belgium, 2610 | |
| Bosnia and Herzegovina | |
| Institute of Oncology - Clinical Center University of Sarajevo | |
| Sarajevo, Bosnia and Herzegovina, 71000 | |
| Chile | |
| Clinica Alemana | |
| Santiago, Chile, 5951 | |
| Instituto de Radiomedicina | |
| Santiago, Chile, 10 | |
| France | |
| CHR de Besancon - Hopital Jean Minjoz | |
| Besancon, France, 25030 | |
| Institut Bergonie | |
| Bordeaux, France, 33076 | |
| Centre de Lutte Contre le Cancer Georges-Francois Leclerc | |
| Dijon, France, 21079 | |
| CHU de Grenoble - Hopital de la Tronche | |
| Grenoble, France, 38043 | |
| Service Cancerologie Polyclinique Clairval | |
| Marseille, France, 13009 | |
| Centre Antoine Lacassagne | |
| Nice, France, 06189 | |
| Centre Eugene Marquis | |
| Rennes, France, 35042 | |
| Centre Leon Berard | |
| Strasbourg, France, 67085 | |
| Institut Gustave Roussy | |
| Strasbourg, France, 67085 | |
| Centre Paul Strauss | |
| Strasbourg, France, 67085 | |
| Centre Hospitalier Universitaire Henri Mondor | |
| Strasbourg, France, 67085 | |
| Germany | |
| Charite - Campus Charite Mitte | |
| Berlin, Germany, D-10117 | |
| Robert Roessle Comprehensive Cancer Center at University of Berlin - Charite Campus Buch | |
| Berlin, Germany, D-13122 | |
| Klinik I fuer Innere Medizin | |
| Cologne, Germany, D-50924 | |
| University of Erlangen-Nuremberg | |
| Erlangen, Germany, DOH-91054 | |
| Universitaetsklinikum Essen | |
| Essen, Germany, D-45122 | |
| Universitaetsklinikum Goettingen | |
| Goettingen, Germany, D-37075 | |
| Universitaetsklinikum Tuebingen | |
| Tuebingen, Germany, D-72076 | |
| Israel | |
| Rambam Medical Center | |
| Haifa, Israel, 31096 | |
| Chaim Sheba Medical Center | |
| Ramat-Gan, Israel, 52621 | |
| Italy | |
| Ospedale Sant Anna | |
| Como, Italy, 22100 | |
| Istituto Nazionale per la Ricerca sul Cancro | |
| Genoa (Genova), Italy, 16132 | |
| Netherlands | |
| Medisch Centrum Haaglanden | |
| 's-Gravenhage (Den Haag, the Hague), Netherlands, 2501 CK | |
| Academisch Medisch Centrum | |
| Amsterdam, Netherlands, 1105 AZ | |
| Streekziekenhuis Gooi-Noord | |
| Blaricum, Netherlands, 1261 AN | |
| Radiotherapeutisch Instituut-(Riso) | |
| Deventer, Netherlands, 7400 AC | |
| Medisch Spectrum Twente | |
| Enschede, Netherlands, 7500 KA | |
| Academisch Ziekenhuis Groningen | |
| Groningen, Netherlands, 9713 GZ | |
| Radiotherapeutisch Instituut Limburg-Maastricht | |
| Maastricht, Netherlands, NL-6229 ET | |
| Dr. Bernard Verbeeten Instituut | |
| Tilburg, Netherlands, 5042 SB | |
| Academisch Ziekenhuis Utrecht | |
| Utrecht, Netherlands, 3584 CX | |
| Poland | |
| Medical University of Gdansk | |
| Gdansk, Poland, 80-211 | |
| Portugal | |
| Instituto Portugues de Oncologia Centro do Porto, SA | |
| Porto, Portugal, 4200-072 | |
| Spain | |
| Institut Catala D'Oncologia | |
| Barcelona, Spain, 08907 | |
| Switzerland | |
| Hopital Cantonal Universitaire de Geneve | |
| Geneva, Switzerland, CH-1211 | |
| Centre Hospitalier Universitaire Vaudois | |
| Lausanne, Switzerland, CH-1011 | |
| UniversitaetsSpital | |
| Zurich, Switzerland, CH-8091 | |
| Turkey | |
| Istanbul University-Institute of Oncology | |
| Istanbul, Turkey, 34390 | |
| United Kingdom | |
| Nottingham City Hospital NHS Trust | |
| Nottingham, England, United Kingdom, NG5 1PB | |
Sponsors and Collaborators
European Organisation for Research and Treatment of Cancer - EORTC
Investigators
| 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 |
More Information
Additional Information:
Publications:
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.
| ClinicalTrials.gov Identifier: | NCT00002851 History of Changes |
| Other Study ID Numbers: | CDR0000065094, EORTC-10925, EORTC-22922 |
| Study First Received: | November 1, 1999 |
| Last Updated: | January 28, 2010 |
| Health Authority: | United States: Federal Government |
Keywords provided by National Cancer Institute (NCI):
|
stage I breast cancer stage II breast cancer stage IIIA breast cancer |
Additional relevant MeSH terms:
|
Breast Neoplasms Neoplasms by Site Neoplasms Breast Diseases Skin Diseases |
ClinicalTrials.gov processed this record on June 17, 2013