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View Clinical Trial (Medical Research Study)
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Radiation Therapy in Treating Women Who Have Undergone Surgery For Ductal Carcinoma In Situ or Stage I or Stage II Breast Cancer - NCT00103181-54601A (Clinical Trial 123743)
Permalink: http://www.ClinicalConnection.com/exp/ExpandedPatientViewStudy123743.aspx
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| City: |
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La Crosse |
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State:
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WI |
| Zip Code: |
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54601 |
| Conditions: |
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Breast Cancer |
| Purpose: |
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RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Giving radiation
therapy in different ways may kill any tumor cells that remain after surgery. It is not yet
known whether whole breast radiation therapy is more effective than partial breast radiation
therapy in treating breast cancer.
PURPOSE: This randomized phase III trial is studying whole breast radiation therapy to see
how well it works compared to partial breast radiation therapy in treating women who have
undergone surgery for ductal carcinoma in situ or stage I or stage II breast cancer.
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| Study summary: |
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OBJECTIVES:
Primary
- Compare local tumor control in women with ductal carcinoma in situ or stage I or II
breast cancer treated with adjuvant whole breast vs partial breast irradiation
following lumpectomy.
Secondary
- Compare overall survival, recurrence-free survival, and distant disease-free survival
in patients treated with these regimens.
- Compare the cosmetic result in patients treated with these regimens.
- Compare fatigue and treatment-related symptoms in patients treated with these regimens.
- Compare perceived convenience of care in patients treated with these regimens.
- Compare acute and late toxic effects of these regimens in these patients.
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to
disease stage (ductal carcinoma in situ [DCIS] only vs invasive and node negative vs
invasive with 1-3 positive nodes), menopausal status (premenopausal vs postmenopausal),
hormone receptor status (estrogen receptor [ER]-positive and/or progesterone receptor
[PR]-positive vs ER-negative and PR-negative), intention to receive chemotherapy (yes vs
no). Patients are randomized to 1 of 2 treatment arms. (Patients who are 50 years of age and
over with DCIS regardless of hormone receptor status AND patients with invasive breast
cancer meeting all of the following criteria: ≥ 50 years of age, node-negative, and
hormone-receptor positive status will not be enrolled in study after 12/30/2006.)
- Arm I: Patients undergo whole breast irradiation (WBI) once daily, 5 days a week for
5-7 weeks.
- Arm II: Patients undergo partial breast irradiation (PBI) twice daily on 5 days over a
period of 5-10 days.
Patients in both arms may receive adjuvant chemotherapy at least 2 weeks prior to initiation
of WBI OR at least 2 weeks after completion of PBI at the discretion of the treating
physician. Patients with ER-positive or PR-positive tumors may also receive hormonal
therapy, beginning 3-12 weeks after completion of adjuvant chemotherapy (or before, during,
or after completion of WBI or PBI for patients not receiving adjuvant chemotherapy) and
continuing for at least 5 years.
After completion of study treatment, patients are followed at 1 and 6 months, every 6 months
for 4.5 years, and then annually thereafter.
PROJECTED ACCRUAL: A total of 4,300 patients (2,150 per treatment arm) will be accrued for
this study within 2 years and 5 months. |
| Criteria: |
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DISEASE CHARACTERISTICS:
- Histologically confirmed ductal carcinoma in situ (DCIS*) or invasive* adenocarcinoma
of the breast
- Stage 0, I, or II disease
- Stage II tumors must be ≤ 3 cm
- Gross disease must be unifocal
- Microscopic multifocality allowed provided total pathological tumor size is
≤ 3 cm
- No proven multicentric carcinoma in more than 1 quadrant or separated by ≥ 4 cm
- No non-epithelial breast malignancies (e.g., sarcoma or lymphoma) NOTE:
*Patients who are 50 years of age and over with DCIS regardless of hormone
receptor status AND patients with invasive breast cancer meeting all of the
following criteria: ≥ 50 years of age, node-negative, and hormone-receptor
positive status will not be enrolled in study after 12/30/2006
- Prior axillary staging required for patients with invasive breast cancer, including 1
of the following:
- Sentinel node biopsy alone (if sentinel node is negative)
- Sentinel node biopsy followed by axillary dissection or sampling with ≥ 6
axillary nodes (if sentinel node is positive)
- Axillary dissection alone with ≥ 6 axillary nodes
- No more than 3 positive axillary nodes
- No axillary nodes with definite evidence of microscopic or macroscopic
extracapsular extension
- No positive non-axillary sentinel nodes (intramammary nodes are staged as
axillary nodes)
- No palpable or radiographically suspicious ipsilateral or contralateral
axillary, supraclavicular, infraclavicular, or internal mammary nodes unless
there is histologic confirmation that these nodes are negative for tumor
- Must have undergone lumpectomy
- Resected margins histologically free of tumor
- Re-excision of surgical margins allowed
- Target lumpectomy cavity clearly delineated AND target lumpectomy/whole breast
reference volume ≤ 30% based on postoperative pre-randomization CT scan
- Final surgery (i.e., lumpectomy, re-excision of margins, or axillary staging
procedure) within the past 42 days
- No suspicious microcalcifications, densities, or palpable abnormalities in the
ipsilateral or contralateral breast unless biopsied and found to be benign
- No Paget's disease of the nipple
- No history of invasive breast cancer or DCIS
- Prior lobular carcinoma in situ treated by surgery alone allowed
- No synchronous bilateral invasive or non-invasive breast cancer
- Partial breast irradiation deemed technically deliverable by radiation oncologist at
a credentialed facility
- Must have undergone a history and physical exam within the past 4 months AND a
bilateral mammogram within the past 6 months
- Hormone receptor status:
- Estrogen receptor (ER) status known
- Progesterone status known if ER analysis is negative
- Marginal or borderline results are considered positive
PATIENT CHARACTERISTICS:
Age
- 18 and over
Sex
- Female
Menopausal status
- Premenopausal or postmenopausal
Performance status
- Not specified
Life expectancy
- At least 10 years, excluding diagnosis of breast cancer
Hematopoietic
- Not specified
Hepatic
- Not specified
Renal
- Not specified
Other
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective non-hormonal contraception
- No other malignancy within the past 5 years except previously treated carcinoma in
situ of the cervix or colon, melanoma in situ, or basal cell or squamous cell skin
cancer
- Deemed to be at low risk for recurrence
- No collagen vascular disease (e.g., systemic lupus erythematosus or scleroderma),
specifically dermatomyositis with a CPK level above normal, or active skin rash
- No psychiatric or addictive disorder that would preclude study therapy
PRIOR CONCURRENT THERAPY:
Biologic therapy
- No prior biologic therapy for this malignancy
Chemotherapy
- No prior chemotherapy for this malignancy
- No concurrent chemotherapy during study radiotherapy
Endocrine therapy
- No prior hormonal therapy for this malignancy unless total duration of hormonal
therapy was no more than 28 days before randomization
- Concurrent hormonal therapy allowed provided it is not administered during
chemotherapy
- No concurrent raloxifene, tamoxifen, or other selective estrogen receptor modulating
drugs
- No concurrent hormone replacement therapy
- No concurrent Femring^®
Radiotherapy
- No prior radiotherapy for this malignancy
- No prior breast or thoracic radiotherapy
- No concurrent brachytherapy boosts
- No concurrent intensity modulated radiotherapy
- No concurrent regional nodal irradiation
Surgery
- See Disease Characteristics
- No prior breast implants
- Patients who have had implants removed are eligible
Other
- No other concurrent anticancer therapy |
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| Study is available at: |
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Gundersen Lutheran Center for Cancer and Blood
La Crosse, WI 54601
United States
Primary Contact:
Clinical Trials Office - Gundersen Lutheran Cancer Center
Email: cancerctr@gundluth.org
Phone: 608-775-2385 |
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If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
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| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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March 15, 2010 |
Modifications to
this listing: |
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Only selected fields are shown, please use the link
above to view all information about this clinical trial. |
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Clinical trials are medical research studies designed to test the safety and/or
effectiveness of new drugs, devices, or treatments in humans. These studies are
conducted worldwide for a range of conditions and illnesses. Learn more about
clinical research and participating in a study at
About Clinical Trials.
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