Clinical trial · Interventional
4D Image-Guided Partial Breast Radiation in Stage 0 and l Breast Cancer
A Pilot Study of Four-Dimensional Conformal Image Guided Accelerated Partial Breast Irradiation In The Treatment Of Stage 0 and l Breast Cancer
NCT01646346CI-TRIAL-00035915completedN/AResults postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The Purpose of this study is to evaluate the feasibility of using image guidance and four-dimensional computed tomography to reduce the volume of non target breast tissue that is treated with accelerated partial breast irradiation via the external beam technique.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 4D Conformal Image-Guided Partial Breast RT | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- 4D Conformal Image-Guided Partial Breast RT
- description
- This is a single arm trial designed to look at the results in women treated with partial breast irradiation twice daily for 5 days.
- interventionNames
- Radiation: 4D Conformal Image-Guided Partial Breast RT
Primary outcomes (1)
- measure
- Patients With Reduction in Incidental Radiation
- timeFrame
- 5 day
- description
- Patients were assessed to determine if there was a reduction in breast radiation V50 less than 45% and V100 less than 23.5%.
Secondary outcomes (6)
- measure
- Cosmesis by Patient Report
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 50 Years
Show eligibility criteria text
Inclusion Criteria: * The patient must consent to be in the study and must have a signed an approved consent form conforming with institutional guidelines. * Patient must be \> 50 years old. * The patient should have a life expectancy of at least two years with a karnofsky performance status \> 70. * The patient must have stage 0 or I breast cancer. * On histological examination, the tumor must be DCIS or invasive adenocarcinoma of the breast. * Surgical treatment of the breast must have been lumpectomy. The margins of the resected specimen must be histologically free of tumor (\>2mm, DCIS and invasive). Re-excision of surgical margins is permitted. * Gross disease must be unifocal with pathologic (invasive and/or DCIS) tumor size 2 cm or less. (Patients with microscopic multifocality are eligible as long as total pathologic tumor size is 2 cm or less.) * Patients with invasive breast cancer are required to have axillary staging which can include sentinel node biopsy alone (if negative), sentinel node biopsy followed by axillary dissection or sampling with a minimum total of 6 axillary nodes or axillary dissection alone (with a minimum of 6 axillary nodes). Axillary staging is NOT required for patients with DCIS. * The patient must have simulation within 8 weeks/56 days of the final surgery for their breast cancer (lumpectomy, re-excision of margins, or axillary staging procedure). * Patients with a history of non-ipsilateral breast malignancies are eligible if they have been disease-free for 2 or more years prior to enrollment. Patients with the following cancers are eligible even if diagnosed and treated within the past 2 years: carcinoma in situ of the cervix, colon, melanoma in situ, and basal cell and squamous cell carcinoma of the skin. * Chemotherapy is permitted if planned for ≥ 2 weeks after radiation. * Urine pregnancy test must be performed and be negative on all women younger than 60 who have not had a tubal ligation, oophorectomy, or hysterectomy. * Separate incisions for the lumpectomy and sentinel node biopsy should be present. Use of only one incision will typically result in a contiguous cavity with the tumor bed and the sentinel node sampling, and inability of the radiation oncologist to delineate the tumor bed from the sentinel node bed. * The patient must have a cavity which is able to be targeted with external beam APBI, either through surgical clip placement, or CVS 3 or higher. The cavity to whole breast ratio must be 30% or less. Exclusion Criteria: * Men are not eligible for this study as men are not breast conservation candidates. * T0, T2 (\> 2.0 cm), T3, node positive, stage III or IV breast cancer. * Any positive axillary nodes. * Palpable or radiographically suspicious ipsilateral or contralateral axillary, supraclavicular, infraclavicular or internal mammary nodes, unless biopsy proven to be negative for tumor. * Suspicious microcalcifications, densities or palpable abnormalities in either breast unless biopsy proven to be benign. * Non-epithelial breast malignancies such as sarcoma or lymphoma. * Proven multicentric carcinoma in more than one quadrant or separated by more than 2 centimeters. * Paget's disease of the nipple. * History of invasive breast cancer or DCIS in the same breast. * Surgical margins that cannot be microscopically assessed or are less then 2 mm. * Collagen vascular disease, specifically dermatomyositis with a CPK level above normal or with an active skin rash, systemic lupus erythematosis or scleroderma. * Pregnancy or lactation at the time of proposed radiation. Women of reproductive potential must agree to use an effective non-hormonal method of contraception during therapy. * Psychiatric or addictive disorders or other conditions that, in the opinion of the treating physician, would preclude the patient from meeting the study requirements. * Patients with coexisting medical conditions in whom life expectancy is \< 2 years. * Patients with skin involvement, regardless of tumor size.
References
Publications (0)
Data not yet available
No reference posted for this study.