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Breast CancerPhase 1NCT00749437

Radiation Therapy Using Gold Markers in Treating Women With Early-Stage Breast Cancer

A Phase 1 study testing 3-dimensional conformal accelerated partial breast irradiation in people with Breast Cancer, run by University of Medicine and Dentistry of New Jersey at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Placing gold markers in the area where the tumor was removed may help doctors better direct radiation therapy and help reduce the risk of cancer recurrence. Read more about this study

Who is it for?
Ages 45 years and older, women only
Conditions the study is for
Breast Cancer
What is being tested?
3-dimensional conformal accelerated partial breast irradiation
Type of treatment
Surgery or procedure
How many people
34 participants
Where
1 siteUnited States
Study dates
Oct 2008to Jul 2010
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 45 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Histologically confirmed ductal carcinoma in situ or invasive carcinoma of the breast (including ductal, medullary, papillary, colloid [mucinous], or tubular histologies) meeting all of the following criteria:
  • AJCC stage 0, I, or II (Tis, T1N0, or T2N0) disease with a lesion ≤ 3 cm treated with lumpectomy and either sentinel node biopsy or axillary dissection (if invasive carcinoma is present)
  • Unifocal breast cancer (i.e., single focus that can be encompassed by one lumpectomy)
  • Underwent or plan to undergo lumpectomy with placement of gold fiducial markers (markers placed concurrently with the surgery or on a later date)
  • Patients who has underwent lumpectomy must meet all of the following criteria:
  • Must be enrolled between 14-60 days from date of last surgery, and radiation must start within 15-80 days of date of last surgery
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  • Four to six gold fiducial markers placed in the tumor bed, delineating the margins of the lumpectomy cavity
  • Negative, inked histologic margins of lumpectomy (> 1 mm) or re-excision specimen to be confirmed prior to radiation
  • Margins are unacceptable if there is invasive or non-invasive tumor within 1 mm of the inked margin
  • Negative post-excision mammography if malignancy-associated microcalcifications were initially present
  • Hormone receptor status not specified

Who cannot join

  • Evidence of suspicious microcalcifications in the breast prior to the start of radiation
  • One or more positive axillary nodes or positive sentinel biopsy
  • Distant metastases
  • Invasive or extensive in-situ lobular carcinoma or non-epithelial breast malignancies such as sarcoma or lymphoma
  • 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 confirmed to be negative for malignancy by biopsy
  • Palpable or radiographically suspicious contralateral axillary, supraclavicular, infraclavicular, or internal mammary nodes, unless there is histologic confirmation that these nodes are negative for tumor
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  • Paget's disease of the nipple
  • Skin involvement, regardless of tumor size
  • PATIENT CHARACTERISTICS:
  • Female
  • Menopausal status not specified
  • ECOG performance status 0-1
  • Life expectancy ≥ 2 years
  • Not pregnant or nursing
  • No prior treated breast carcinoma within the past 5 years
  • No collagen vascular diseases, specifically systemic lupus erythematosus, scleroderma, or dermatomyositis
  • No co-existing medical conditions
  • No patients with medical conditions that would preclude compliance with the trial, as determined by the investigator
  • No other malignancy, except non-melanomatous skin cancer, within the past 5 years
  • Disease-free interval from any prior carcinoma must be continuous
  • No breast technically unsuitable for radiotherapy
  • PRIOR CONCURRENT THERAPY:
  • See Disease Characteristics
  • Concurrent tamoxifen citrate, anastrozole, or other hormonal therapy allowed
  • Future chemotherapy allowed provided it is administered after the APBI and begins no earlier than 2 weeks after completion of radiotherapy
  • No tylectomies so extensive that the cosmetic result is low or poor prior to radiation
  • No prior radiation to the ipsilateral breast
  • No prior non-hormonal therapy or radiotherapy for this disease
  • No chemotherapy in the past 2 weeks
  • No concurrent chemotherapy, immunotherapy, or experimental medications

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School

    New Brunswick, New Jersey, 08903

Other trials in United States

About this study

Official title: Feasibility of 3-D Conformal Accelerated Partial Breast Irradiation (APBI) for Early Stage, Node Negative Breast Cancer Patients Using Acculoc Fiducial Markers: A Phase I Trial

RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Placing gold markers in the area where the tumor was removed may help doctors better direct radiation therapy and help reduce the risk of cancer recurrence.

PURPOSE: This phase I trial is studying how well radiation therapy using gold markers works in treating women with early-stage breast cancer.

Read the detailed description

OBJECTIVES:

Primary

  • To determine if the delivery of external-beam accelerated partial breast irradiation (APBI) based on gold fiducial markers is more accurate when compared to the delivery of radiotherapy based on bony anatomy in women with early-stage, node-negative breast cancer.

Secondary

  • To assess the migration of fiducial markers during a course of APBI.
  • To quantify the change in the volume of the seroma (lumpectomy) cavity during a course of APBI.
  • To compare overall operative time for suturing fiducial markers into place vs current standard method of placing surgical clips.

OUTLINE: Patients undergo planned lumpectomy with gold fiducial marker placement (if procedure not already performed). Patients who meet the post lumpectomy criteria for continue treatment in this study proceed to accelerated partial breast irradiation (APBI). Between 15-80 days after surgery, patients undergo 3-dimensional APBI (may be intensity-modulated radiotherapy) using CT-guided planning (with gold fiducial markers placed at lumpectomy) once daily, 5 days a week, for 15 days.

Patients undergo fluoroscopy weekly to determine real-time movement of bony anatomy and fiducial markers and cone-beam CT weekly to determine any change in volume of seroma cavity.

Conditions
Breast Cancer
Being tested
3-dimensional conformal accelerated partial breast irradiation
Keywords
stage I breast cancer, stage II breast cancer, ductal breast carcinoma in situ, invasive ductal breast carcinoma, medullary ductal breast carcinoma with lymphocytic infiltrate, papillary ductal breast carcinoma, tubular ductal breast carcinoma, mucinous ductal breast carcinoma, breast cancer in situ
Medical subject headings
Breast Neoplasms, Carcinoma, Intraductal, Noninfiltrating, Carcinoma, Ductal, Breast, Breast Carcinoma In Situ

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 3-dimensional conformal accelerated partial breast irradiationRadiation

    Accelerated partial breast irradiation following lumpectomy with placement of Acculoc fiducial markers.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Amount of the shifts of the radiation fields based on bony anatomy as compared to that of gold fiducial markers

    Measured: During radiation therapy

Secondary outcomes (1)

  1. Movement of the fiducial markers themselves and the change in volume of the seroma cavity during a 15-fraction course of accelerated radiotherapy compared with the pre-radiation volume

    Measured: During radiation therapy

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Sep 2008 (estimated)
  2. Study startOct 2008
  3. Primary completionJul 2010
  4. Study completionJul 2010

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
34 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00749437
Sponsor's protocol ID
040801
Other IDs
P30CA072720, CINJ-040801, CINJ-0220080173
Status last verified
Jun 2012
First submitted
6 Sep 2008
Last updated
14 Jun 2012
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing 3-dimensional conformal accelerated partial breast irradiation in people with Breast Cancer, run by University of Medicine and Dentistry of New Jersey at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 30 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 Jun 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Amount of the shifts of the radiation fields based on bony anatomy as compared to that of gold fiducial markers (time frame: During radiation therapy). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00749437.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jun 2012.

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