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3-Dimensional Conformal Radiation Therapy In Treating Women With Stage I or Stage II Breast Cancer Previously Treated With Lumpectomy and Axillary Node Dissection

A Phase I/II Trial to Evaluate Three Dimensional Conformal Radiation Therapy (3D-CRT) Confined to the Region of the Lumpectomy Cavity for Stage I and II Breast Carcinoma

Status
Completed
Phases
Phase 1Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00068263
Enrollment
Unknown
Registered
2003-09-11
Start date
2003-08-31
Completion date
2016-12-31
Last updated
2017-01-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer

Keywords

stage I breast cancer, stage II breast cancer

Brief summary

RATIONALE: 3-dimensional conformal radiation therapy delivers a high dose of radiation directly to the tumor and may kill more tumor cells and cause less damage to normal tissue. PURPOSE: Phase I/II trial to study the effectiveness of 3-dimensional conformal radiation therapy in treating women who have undergone lumpectomy and axillary node dissection for stage I or stage II breast cancer.

Detailed description

OBJECTIVES: * Determine the technical feasibility and reproducibility of three-dimensional conformal radiotherapy confined to the region of the lumpectomy cavity in women with stage I or II breast cancer. * Determine the cosmetic results in patients treated with this regimen. * Determine the complication rates in patients treated with this regimen. * Determine the local control rate in patients treated with this regimen. OUTLINE: This is a multicenter study. Patients undergo three-dimensional conformal radiotherapy twice daily for 5 days beginning within 8 weeks after surgery. Patients are followed at 6 weeks, every 3 months for 1 year, every 4 months for 1 year, every 6 months for 3 years, and then annually thereafter. PROJECTED ACCRUAL: A total of 19-46 patients will be accrued for this study within 6.3 to 15.3 months.

Interventions

RADIATIONradiation therapy

Sponsors

National Cancer Institute (NCI)
CollaboratorNIH
NRG Oncology
CollaboratorOTHER
Radiation Therapy Oncology Group
Lead SponsorNETWORK

Study design

Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

DISEASE CHARACTERISTICS: * Histologically confirmed invasive breast cancer * Stage I or II (T1, N0; T1, N1; T2, N0; or T2, N1) * Unifocal disease (single focus that can be encompassed by one lumpectomy) * The following histologies are eligible: * Invasive ductal * Medullary * Papillary * Colloid (mucinous) * Tubular * No invasive or extensive in situ lobular carcinoma or pure ductal carcinoma in situ (DCIS) * No nonepithelial breast malignancies such as sarcoma or lymphoma * Previously treated with lumpectomy of a lesion no greater than 3 cm and axillary dissection of at least 6 lymph nodes or a sentinel node biopsy * Six surgical clips in place delineating the margins of the tylectomy cavity * Negative, inked histologic margins of lumpectomy (greater than 2 mm) OR re-excision specimen available for confirmation * Negative mammography post-lumpectomy or post-excision if malignancy-associated microcalcifications were initially present * No prior lumpectomy so extensive that the cosmetic result is low or poor prior to radiotherapy * No more than 3 positive axillary nodes * No proven multicentric carcinoma (tumors in different quadrants of the breast or tumor separated by at least 4 cm) with other clinically or radiographically suspicious areas in the ipsilateral breast unless negative by biopsy * No palpable or radiographically suspicious contralateral axillary, supraclavicular, infraclavicular, or internal mammary nodes unless nodes are histologically negative * No extensive intraductal carcinoma, indicated by one of the following according to the Harvard definition: * More than 25 % of invasive tumor is DCIS and DCIS is in adjacent breast tissue * Intraductal carcinoma with microinvasion * No previously treated contralateral breast cancer or synchronous ipsilateral breast cancer * No evidence of suspicious microcalcifications * No Paget's disease of the nipple * No skin involvement by disease, regardless of tumor size * No distant metastases * Hormone receptor status: * Not specified PATIENT CHARACTERISTICS: Age * 18 and over Sex * Female Menopausal status * Not specified Performance status * Not specified Life expectancy * At least 2 years Hematopoietic * Not specified Hepatic * Not specified Renal * Not specified Other * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * Technically suitable for breast radiotherapy * No collagenous diseases (e.g., systemic lupus erythematosus, scleroderma, or dermatomyositis) * No other medical condition that would limit life expectancy * No psychiatric or addictive disorders that would preclude giving informed consent * No other malignancy within the past 5 years except nonmelanoma skin cancer PRIOR CONCURRENT THERAPY: Biologic therapy * Not specified Chemotherapy * At least 2 weeks since prior chemotherapy * No concurrent chemotherapy during and for at least 2 weeks after completion of study therapy Endocrine therapy * Concurrent anastrozole or tamoxifen allowed Radiotherapy * No prior radiotherapy for the current malignancy Surgery * See Disease Characteristics Other * No prior nonhormonal therapy for the current malignancy

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026