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Home > "C" Clinical Trials Conditions > Comparison of Complete Axillary Lymph Node Dissection With Axillary Radiation Therapy in Treating Women With Invasive Breast Cancer  Comparison of Complete Axillary Lymph Node Dissection With Axillary Radiation Therapy in Treating Women With Invasive Breast Cancer
Comparison of Complete Axillary Lymph Node Dissection With Axillary Radiation Therapy in Treating Women With Invasive Breast Cancer
For Condition: stage 1 breast cancer,stage 2 breast cancer
Status: Recruiting
Sponsor(s): EORTC Breast Cancer Cooperative Group ,
Synopsis: RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells and may be a less invasive treatment and cause fewer side effects than complete axillary lymph node dissection. It is not yet known which treatment is more effective for invasive breast cancer. PURPOSE: Randomizedphase III trial to compare the effectiveness of complete axillary lymph node dissection with that of axillary radiation therapy in treating women who have invasive breast cancer.
Details: OBJECTIVES: - Compare the regional control of the axilla obtained by complete axillary lymph node dissection vs axillary radiotherapy in sentinel lymph node-positive women with operable invasive breast cancer. - Determine whether local and regional axillary control can be obtained without axillary lymph node dissection in sentinel lymph node-negative women. - Compare the axillary 5-year recurrence-free survival of these patients treated with these regimens. - Compare the morbidity of patients treated with these regimens. - Compare the quality of life of these patients treated with these regimens. OUTLINE: This is a randomized, multicenter study. Patients are stratified according to participating center and type of breast surgery (conservation vs total mastectomy). Patients are randomized to 1 of 2 treatment arms. Patients are given an injection of a tracer and undergo lymphoscintigraphy 2-3 hours later to identify the sentinel lymph node. Within 24 hours after lymphoscintigraphy, patients undergo wide local excision of the tumor or mastectomy after the sentinel node is removed. If no sentinel node is found or metastasis is found in a nonsentinel node, patients undergo complete axillary lymph node dissection (ALND) regardless of randomization. Sentinel node-negative patients receive no further treatment. Sentinel node-positive patients continue treatment according to randomization. - Arm I: Within 8 weeks after surgery, patients undergo complete ALND. - Arm II: Within 8 weeks after surgery, patients undergo axillary lymph node radiotherapy daily 5 days a week for 5 weeks. Patients in arm I may receive postoperative axillary irradiation if 4 or more nodes are positive and more than 1 axillary level is involved. Quality of life is assessed at baseline and then at 1, 2, 3, and 5 years. Patients are followed annually for 5 years. PROJECTED ACCRUAL: A total of 3,485 patients (1,394 sentinel node-positive and 2,091 sentinel node-negative) will be accrued for this study within 3 years.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: /
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically or "triple diagnosis" (palpation, mammogram or ultrasound, and cytology) confirmed operable invasive breast cancer - T0-2, N0 - Diagnosis by excisional tumorectomy allowed - Clinically occult invasive disease must be histologically confirmed - Only 1 tumor in 1 breast - Tumor between 5 and 30 mm in largest diameter by mammogram or ultrasound - Bilateral unifocal invasive breast cancer allowed if determined by bilateral mammogram - Clinically negative axillary lymph nodes - No metastatic disease - Hormone receptor status: - Not specified PATIENT CHARACTERISTICS: Age: - Any age Sex: - Female Menopausal status: - Not specified Performance status: - Not specified Life expectancy: - Not specified Hematopoietic: - Not specified Hepatic: - Not specified Renal: - Not specified Other: - Fit to undergo sentinel node biopsy, axillary clearance, breast surgery, and/or axillary radiotherapy - No psychological, familial, sociological, or geographical condition that would preclude study compliance - No other prior malignancy except basal cell skin cancer or carcinoma in situ of the cervix - Not pregnant PRIOR CONCURRENT THERAPY: Biologic therapy: - Not specified Chemotherapy: - Not specified Endocrine therapy: - Not specified Radiotherapy: - No prior radiotherapy to axilla Surgery: - No prior surgery to axilla
Total Enrollment:
Location and Contact Information:
Overall Study Official:
EmielRutgers, , Netherlands Cancer Institute - Antoni van Leeuwenhoek Hospital
Red Cross Hospital *Recruiting*
Den Haag, , 2566 MJ
Netherlands
Recruiting Contact Person 31-70-360-8068
Leyenburg Ziekenhuis *Recruiting*
's-Gravenhage, , 2545 CH
Netherlands
Recruiting Contact Person 31-70-359-2653
Academisch Medisch Centrum *Recruiting*
Amsterdam, , 1105 AZ
Netherlands
Recruiting Contact Person 31-20-566-9111
Reinier de Graaf Group *Recruiting*
Delft, , NL 2600 GA
Netherlands
Recruiting Contact Person 31-15-260-3060
Ziekenhuis St Jansdal *Recruiting*
Harderwijk, , 3840 AC
Netherlands
Recruiting Contact Person 31-341-463-911
Universita Degli Studi di Firenze - Policlin. di Careggi *Recruiting*
Firenze (Florence), , 1 (50134)
Italy
Recruiting Contact Person 39-43-780-51
Leiden University Medical Center *Recruiting*
Leiden, , 2300 CA
Netherlands
Recruiting Contact Person 31-71-526-911
Rijnstate Hospital *Recruiting*
ARNHEM, , 6800 TA
Netherlands
Recruiting Contact Person 31-26-378-8888
Institute of Oncology, Ljubljana *Recruiting*
LJUBLJANA, , Sl-1000
Slovenia
Recruiting Contact Person 386-1-323-063
Gelre Ziekenhuizen - Lokatie Lukas *Recruiting*
Apeldoorn, , 7334 DZ
Netherlands
Recruiting Contact Person 31-55-581-8181
Netherlands Cancer Institute - Antoni van Leeuwenhoek Hospital *Recruiting*
Amsterdam, , 1066 CX
Netherlands
Recruiting Contact Person 31-20-512-9111
Ospedale S. Giovanni A.S. Dipartimente di Oncologia di Torino *Recruiting*
Turin, , 10123
Italy
Recruiting Contact Person 39-575-4821
Catharina Ziekenhuis *Recruiting*
Eindhoven, , 5602 ZA
Netherlands
Recruiting Contact Person 31-40-239-9111
Academisch Ziekenhuis Groningen *Recruiting*
Groningen, , 9713 EZ
Netherlands
Recruiting Contact Person 31-50-361-6161
NIJ Smellinghe *Recruiting*
Drachten, , NL-9200 DA
Netherlands
Recruiting Contact Person 31-512-588-888
Additional Information:
Study ID Numbers: CDR0000068566; EORTC-10981,EORTC-10981-AMAROS
Study Start Date:
Record last reviewed: March 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00014612
Other Stage 1 Breast Cancer Studies:
1. Study of Health Promotion in Patients With Early-Stage Breast or Prostate Cancer
2. Surgery With or Without Lymph Node Removal in Treating Older Women With Stage I Breast Cancer
3. Cryosurgery in Treating Women With Breast Lesions
4. Trastuzumab in Treating Women With Breast Cancer
5. Exemestane Compared With Tamoxifen in Treating Postmenopausal Women With Primary Breast Cancer
Related Studies:
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Comparison of Complete Axillary Lymph Node Dissection With Axillary Radiation Therapy in Treating Women With Invasive Breast Cancer
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