Clinical trial NCT00581529: Partial Breast Irradiation Using Accelerated Intensity Modulated Radiotherapy
Official title: Partial Breast Irradiation Using Accelerated Intensity Modulated Radiotherapy in Early Stage Breast Cancer After Breast-Conserving Surgery
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Breast Cancer
Keywords: breast
Lead sponsor: University of Michigan Rogel Cancer Center
Sponsor class: OTHER
First posted: 2007-12-27
Enrollment: 34
Sex: FEMALE
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is a phase I- II feasibility study for delivering partial breast irradiation (PBI) in selected patients with early stage, lymph node negative, breast cancer after breast-conserving surgery using accelerated Intensity Modulated Radiotherapy (IMRT).

Detailed description: This is a non-randomized Phase I-II feasibility study of partial breast irradiation with accelerated IMRT technique. In this study, patients will be eligible if the estimated risk of breast cancer elsewhere in the breast (beyond the tumor bed) is low. The radiation treatment will be available to women who are older than 40 years, have a DCIS (Ductal carcinoma in situ) or T1, N0, M0, (AJCC classification, version 6.0), non-lobular infiltrating carcinoma treated with breast-conserving surgery.

Patients will undergo a pre-treatment planning free breathing CT with 5mm cuts in the treatment position, on a breast board, with both arms extended above their head that will be used to plan the traditional two field (tangent) plan. An Active Breathing Control (ABC) device will be used to minimize target motion due to breathing during a second CT scan. The lumpectomy cavity will be identified and delineated, and margins of approximately 1.5 cm in three dimensions will be used to allow for subclinical tumor extension and daily set-up error. The organs at risk (heart, lungs, contralateral breast) will be contoured on both CT scans. An inverse planning system and optimization tools will be employed in order to achieve the best IMRT plan (to minimize the dose to the heart, lungs and contralateral breast), that will be compared to the two field plan. If the IMRT plan is shown to be the optimal one, in terms of doses to organs at risk, then the patient will be enrolled in the protocol and will proceed with the treatment. Treatment will start approximately two weeks after the planning CT is obtained. All patients on protocol will be treated with accelerated radiotherapy, 3.85 Gy per fraction, bid, for 5 consecutive days for a total dose of 38.5 Gy.

Eligibility criteria: Inclusion Criteria:

* Patient with unifocal histologically proven breast cancer, with or without calcifications in mammogram.
* DCIS (Ductal carcinoma in situ) (Tis, Stage 0)
* Non-lobular infiltrating carcinoma, maximum of 2 cm in diameter. (T1, Stage I)
* The patient was operated on and the tumor was excised with lumpectomy
* The tumor is reported with negative margins \>3 mm, as per our hospital protocol.
* For invasive carcinoma, axillary lymph nodes are negative by sentinel lymph node (SLN) mapping and biopsy or by formal axillary lymph node dissection.
* The patient is over 40 years old with life expectancy of at least 5 years
* Karnofsky status must be at least 70. See appendix I.
* Pre- and post-menopausal women are eligible for entry.
* The patient must be aware of the neoplastic nature of her disease and must be willing to consent after being informed of the potential benefits, side effects and risks of radiotherapy. Institutional Review Board approval of this protocol and a consent form is required.

Exclusion Criteria:

* No concurrent or neoadjuvant chemotherapy is allowed. Patient is permitted to be treated with chemotherapy or hormone therapy only after completion of the radiation treatment.
* Patients with diffuse calcifications, multifocal or multicentric disease, lymph-vascular invasion are excluded.
* Patients cannot participate if there is extensive LCIS (Lobular carcinoma in situ) in specimen or extensive DCIS.
* Patients are excluded if systemic disease is present or the patient has been irradiated to the ipsilateral breast or the chest wall.
* Patients who are carriers of BRCA 1/2 mutations or at high risk for hereditary breast cancer due to strong family history (more than one pre-menopausal family member with breast cancer or any ovarian cancer) are excluded because of the increased potential for in-breast recurrence elsewhere in the breast in the absence of whole breast radiotherapy.
* Patients with scleroderma, or systemic or discoid lupus are excluded due to the potential for significant radiotherapy associated toxicity.
* Pregnant woman cannot participate in the study.
* Patients who have serious medical problems which would limit survival to \<5 years or a psychiatric condition which would prevent informed consent cannot participate.
* Patients who are unable to lie on their back and raise their arms above their heads in the treatment planning position for radiotherapy are excluded.
* Patients that have mammographically occult disease are excluded.

Primary outcomes:
measure: Rate of Local Control at 5 Years
timeFrame: 5 years
measure: Percentage of Participants That Experience Cosmetic Adverse Events (AEs)
timeFrame: 5 years
Secondary outcomes:
measure: Dosimetric and Volumetric Differences Between Treatment Plans for Partial Breast Irradiation and Other Treatment Planning Methods
timeFrame: not specific
measure: Mean Percentage of Reference Volume Receiving 19.25 Gy and 38.5Gy for Patients With Acceptable and Unacceptable Cosmesis
timeFrame: 5 years
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
Study officials:
affiliation: University of Michigan
name: Lori J Pierce, MD
role: PRINCIPAL_INVESTIGATOR
References: