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Partial Breast Irradiation Using Accelerated Intensity Modulated Radiotherapy

Primary Purpose

Breast Cancer

Status

Terminated

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

IMRT

About this trial

This is an interventional treatment trial for Breast Cancer focused on measuring breast

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

University of Michigan

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Radiotherapy

Arm Description

IMRT (Intensity-modulated Radiation Therapy), 3.85 Gy per fraction, bid, for 5 consecutive days for a total dose of 38.5 Gy.

Outcomes

Primary Outcome Measures

Rate of Local Control at 5 Years

The primary objective was to determine the rate of local control (the arrest of cancer growth at the site of origin) of cancer in the treated breast at 5 years following breast-conserving surgery and partial breast radiotherapy using IMRT.

Percentage of Participants That Experience Cosmetic Adverse Events (AEs)

The primary outcome was to determine the rate of acute cosmetic adverse events and late cosmetic adverse events at follow-up visits over 5 years. To determine the rate of adverse events, the percentage of participants experiencing no cosmetic AEs, at least 1 grade 1 toxicity, at least 1 grade 2 toxicity, and at least 1 grade 3 toxicity were calculated.

Secondary Outcome Measures

Dosimetric and Volumetric Differences Between Treatment Plans for Partial Breast Irradiation and Other Treatment Planning Methods

Dosimetric and volumetric differences between treatment plans for partial breast irradiation and other treatment planning methods for the target (partial breast) and organs at risk (e.g. heart, ipsilateral lung, contralateral breast)a subset of 20.

Mean Percentage of Reference Volume Receiving 19.25 Gy and 38.5Gy for Patients With Acceptable and Unacceptable Cosmesis

One of the studies secondary outcomes was to evaluate the impact of short term accelerated partial breast radiation therapy on cosmetic results. To determine the association between dosimetric factors and cosmesis, the mean percentage of prescription dose received to WBV (Whole breast volume: corresponding region typically encompassed by traditional tangent fields) was compared among participants who developed fair/poor (F/P) cosmetic outcomes (unacceptable cosmesis) and participants who maintained excellent/good (E/G) cosmetic outcomes (acceptable cosmesis).

Full Information

NCT ID

NCT00581529

First Posted

December 20, 2007

Last Updated

September 28, 2017

Sponsor

University of Michigan Rogel Cancer Center

1. Study Identification

Unique Protocol Identification Number

NCT00581529

Brief Title

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

2. Study Status

Record Verification Date

September 2017

Overall Recruitment Status

Terminated

Why Stopped

The trial was terminated early because fair/poor cosmesis developed in 7 of 32 women.

Study Start Date

November 2004 (undefined)

Primary Completion Date

October 2010 (Actual)

Study Completion Date

August 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University of Michigan Rogel Cancer Center

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Breast Cancer

Keywords

breast

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

34 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Radiotherapy

Arm Type

Experimental

Arm Description

IMRT (Intensity-modulated Radiation Therapy), 3.85 Gy per fraction, bid, for 5 consecutive days for a total dose of 38.5 Gy.

Intervention Type

Radiation

Intervention Name(s)

IMRT

Intervention Description

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.

Primary Outcome Measure Information:

Title

Rate of Local Control at 5 Years

Description

Time Frame

5 years

Title

Percentage of Participants That Experience Cosmetic Adverse Events (AEs)

Description

Time Frame

5 years

Secondary Outcome Measure Information:

Title

Dosimetric and Volumetric Differences Between Treatment Plans for Partial Breast Irradiation and Other Treatment Planning Methods

Description

Time Frame

not specific

Title

Mean Percentage of Reference Volume Receiving 19.25 Gy and 38.5Gy for Patients With Acceptable and Unacceptable Cosmesis

Description

Time Frame

5 years

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

40 Years

Accepts Healthy Volunteers

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Lori J Pierce, MD

Organizational Affiliation

University of Michigan

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of Michigan

City

Ann Arbor

State/Province

Michigan

ZIP/Postal Code

48109-5010

Country

United States

12. IPD Sharing Statement

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Partial Breast Irradiation Using Accelerated Intensity Modulated Radiotherapy

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