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Home > "L" Clinical Trials Conditions > Lymph Node Radiation Therapy in Patients with Stage I, Stage II, or Stage III Breast Cancer That Has Been Surgically Removed

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



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

For Condition: stage 3A breast cancer,stage 1 breast cancer,stage 2 breast cancer
Status: Recruiting
Sponsor(s): EORTC Breast Cancer Cooperative Group , EORTC Radiotherapy Cooperative Group
Synopsis: RATIONALE: Radiation therapy may kill any tumor cells remaining after surgery. PURPOSE: Randomizedphase III trial to study the effectiveness of radiation therapy in treating women who have stage I, stage II, or stage III breast cancer that has been surgically removed.
Details: 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:
Study Type:
  Interventional, Treatment
Minimum Age/Maximum Age: /75 Years
Genders: Both
Protocol 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 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
Total Enrollment: 

Location and Contact Information:

Overall Study Official:
WalterVan den Bogaert,  ,  U.Z. Gasthuisberg

Istanbul University-Institute of Oncology *Recruiting*
Istanbul,  ,  34390
Turkey
Recruiting Contact  Person 90-212-531-3100

Cliniques Universitaires Saint-Luc *Recruiting*
Brussels,  ,  1200
Belgium
Recruiting Contact  Person 32-2-764-1111

Nottingham City Hospital NHS Trust *Recruiting*
Nottingham,  England,  NG5 1PB
United Kingdom
Recruiting Contact  Person 44-115-969-1169

Istituto Nazionale per la Ricerca sul Cancro *Recruiting*
Genoa (Genova),  ,  16132
Italy
Recruiting Contact  Person 39-10-560-0848

Centre Hospitalier Universitaire Vaudois *Recruiting*
Lausanne,  ,  CH-1011
Switzerland
Recruiting Contact  Person 41-21-314-1111

Rambam Medical Center *Recruiting*
Haifa,  ,  31096
Israel
Recruiting Contact  Person 972-4-854-3013

Universitaetsklinikum Essen *Recruiting*
ESSEN,  ,  D-45122
Germany
Recruiting Contact  Person 49-201-72-311

Centre Paul Strauss *Recruiting*
Strasbourg,  ,  67085
France
Recruiting Contact  Person 33-3-8825-2424

Medical University of Gdansk *Recruiting*
Gdansk,  ,  80-211
Poland
Recruiting Contact  Person 48-58-349-2222

University of Cologne *Recruiting*
Cologne,  ,  D-50924
Germany
Recruiting Contact  Person 49-221-478-4400

Academisch Medisch Centrum *Recruiting*
Amsterdam,  ,  1105 AZ
Netherlands
Recruiting Contact  Person 31-20-566-9111

Universitaetsklinikum Charite *Recruiting*
Berlin,  ,  D-10117
Germany
Recruiting Contact  Person 49-30-28-020

Institute of Oncology - Clinical Center University of Sarajevo *Recruiting*
Sarajevo,  ,  71000
Bosnia and Herzegovina
Recruiting Contact  Person 387-33-213-519

Centre Leon Berard *Recruiting*
Strasbourg,  ,  67085
France
Recruiting Contact  Person 33-4-7878-2828

Radiotherapeutisch Instituut-(Riso) *Recruiting*
Deventer,  ,  7400 AC
Netherlands
Recruiting Contact  Person 31-570-646-900

UniversitaetsSpital *Recruiting*
Zurich,  ,  CH-8091
Switzerland
Recruiting Contact  Person 41-1-255-1111

Instituto de Radiomedicina *Recruiting*
Santiago,  ,  10
Chile
Recruiting Contact  Person 56-206-1400

Robert Roessle Klinik *Recruiting*
Berlin,  ,  D-13122
Germany
Recruiting Contact  Person 49-30-9417-1492

CHU de Grenoble - Hopital de la Tronche *Recruiting*
Grenoble,  ,  38043
France
Recruiting Contact  Person 33-4-7676-7575

CHR de Besancon - Hopital Jean Minjoz *Recruiting*
Besancon,  ,  25030
France
Recruiting Contact  Person 33-3-8166-8166

Medisch Spectrum Twente *Recruiting*
ENSCHEDE,  ,  7500 KA
Netherlands
Recruiting Contact  Person 31-53-487-2000

Ospedale Sant Anna *Recruiting*
Como,  ,  22100
Italy
Recruiting Contact  Person 39-31-585-600

Clinica Alemana *Recruiting*
Santiago,  ,  5951
Chile
Recruiting Contact  Person 56-2-210-1111

University of Erlangen-Nuremberg *Recruiting*
Erlangen,  ,  DOH-91054
Germany
Recruiting Contact  Person 49-911-85-3386

Hopital de Jolimont *Recruiting*
Haine-Saint-Paul,  ,  7100
Belgium
Recruiting Contact  Person 32-64-23-3011

Instituto Portugues de Oncologia Centro do Porto, SA *Recruiting*
Porto,  ,  4200-072
Portugal
Recruiting Contact  Person 351-22-550-2011

Academisch Ziekenhuis Groningen *Recruiting*
Groningen,  ,  9713 GZ
Netherlands
Recruiting Contact  Person 31-50-361-6161

Algemeen Ziekenhuis Sint-Augustinus *Recruiting*
Wilrijk,  ,  2610
Belgium
Recruiting Contact  Person 32-3-443-3011

Dr. Bernard Verbeeten Instituut *Recruiting*
Tilburg,  ,  5042 SB
Netherlands
Recruiting Contact  Person 31-13-594-7777

Institut Gustave Roussy *Recruiting*
Strasbourg,  ,  67085
France
Recruiting Contact  Person 33-1-4211-4211

Academisch Ziekenhuis Utrecht *Recruiting*
Utrecht,  ,  3584 CX
Netherlands
Recruiting Contact  Person 31-30-250-9111

Universitaetsklinik Goettingen *Recruiting*
Goettingen,  ,  D-37075
Germany
Recruiting Contact  Person 49-551-398-600

Algemeen Ziekenhuis Middelheim *Recruiting*
Antwerp,  ,  2020
Belgium
Recruiting Contact  Person 32-3-280-3111

Universitaetsklinikum Tuebingen *Recruiting*
Tuebingen,  ,  D-72076
Germany
Recruiting Contact  Person 49-0-7071-290

Centre Eugene Marquis *Recruiting*
Rennes,  ,  35042
France
Recruiting Contact  Person 33-2-9925-3178

Chaim Sheba Medical Center *Recruiting*
Ramat-Gan,  ,  52621
Israel
Recruiting Contact  Person 972-3-530-2406

Cazk Groeninghe - Campus Maria's Voorzienigheid *Recruiting*
Kortrijk,  ,  B-8500
Belgium
Recruiting Contact  Person 32-562-34-211

Institut Bergonie *Recruiting*
Bordeaux,  ,  33076
France
Recruiting Contact  Person 33-5-5633-3333

Radiotherapeutisch Instituut Limburg-Maastricht *Recruiting*
Maastricht,  ,  NL-6229 ET
Netherlands
Recruiting Contact  Person 31-45-455-771-200

Centre Antoine Lacassagne *Recruiting*
Nice,  ,  06189
France
Recruiting Contact  Person 33-4-9203-1000

Service Cancerologie Polyclinique Clairval *Recruiting*
Marseille,  ,  13009
France
Recruiting Contact  Person 33-4-9117-1291

Centre Hospitalier Universitaire Henri Mondor *Recruiting*
Strasbourg,  ,  67085
France
Recruiting Contact  Person 33-1-4981-2111

Medisch Centrum Haaglanden *Recruiting*
's-Gravenhage (Den Haag, The Hague),  ,  2501 CK
Netherlands
Recruiting Contact  Person 31-70-88-9393

Streekziekenhuizen Gooi-Noord *Recruiting*
Blaricum,  ,  1261 AN
Netherlands
Recruiting Contact  Person 31-35-539-1111

Hopital Cantonal Universitaire de Geneve *Recruiting*
Geneva,  ,  CH-1211
Switzerland
Recruiting Contact  Person 41-22-372-3311

U.Z. Gasthuisberg *Recruiting*
Leuven,  ,  B-3000
Belgium
Recruiting Contact  Person 32-16-33-2211

Institut Catala D'Oncologia *Recruiting*
Barcelona,  ,  08907
Spain
Recruiting Contact  Person 34-3-357-652

Centre de Lutte Contre le Cancer, Georges-Francois Leclerc *Recruiting*
Dijon,  ,  21079
France
Recruiting Contact  Person 33-3-8073-7500


Additional Information:
Study ID Numbers:
  CDR0000065094;  EORTC-10925,EORTC-22922
Study Start Date: 
Record last reviewed: December 2000
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00002851

Other Stage 3a Breast Cancer Studies:
1. Adjuvant Chemotherapy in Treating Women Who Have Undergone Resection for Relapsed Breast Cancer

2. Tamoxifen With or Without Combination Chemotherapy in Treating Postmenopausal Women With Operable Invasive Breast Cancer

3. Chemotherapy Followed by Surgery in Treating Women With Stage II or Stage III Breast Cancer

4. Vaccine Therapy With Either Neoadjuvant or Adjuvant Chemotherapy and Adjuvant Radiation Therapy in Treating Women With p53-Overexpressing Stage II or Stage III Breast Cancer

5. Combination Chemotherapy Followed by Radiation Therapy With or Without Surgery in Treating Women With Locally Advanced or Inflammatory Breast Cancer

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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

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