Study of Prone Accelerated Breast And Nodal IMRT

April 25, 2023 updated by: NYU Langone Health

PHASE I - II STUDY OF PRONE ACCELERATED BREAST AND NODAL IMRT(Intensity-Modulated Radiation Therapy)

Following consent, patients will receive 15 fractions of radiotherapy to the affected breast and to Axillary level III and SCV (Supra-Clavicular) lymph nodes, defined by CT imaging obtained in a prone position using IMRT(intensity modulation radiation therapy ) technique: one fraction daily for 5 days/week for 3 consecutive weeks. Patients will be seen for follow-up at 45-60 days from first radiotherapy treatment, and then yearly. Patients will be assessed for Lymphedema at baseline, end of treatment, and at yearly intervals after completion of radiotherapy. All patients will be followed for toxicity and outcome (local and systemic recurrence, survival). In addition, patients will complete a self-assessment of QOL at baseline, week 3, day 45-60 and 2-yr follow-ups.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

A recent Cochrane Collaboration Intervention Review has addressed the effects of altered fractionation size on women with early breast cancer who have undergone breast conservation surgery. Analysis of two prospective randomized trials that included 2644 women, selected based on tumor size less than five cm, negative pathological margin of excision and negative lymph nodes. No difference in clinical outcome was detected. The conclusion of the review is that the use of unconventional fractionation regimens (greater than 2 Gy per fraction) does not affect breast appearance or toxicity, and does not seem to affect local recurrence or five years survival rates.

After breast surgery and an adequate axillary dissection (i.e., at least 8 nodes retrieved in the axillary dissection specimen from level I and II) it is possible to identify patients with 1 - 5 positive nodes who require radiotherapy to both the indexed breast/chest wall and the draining nodal stations that the surgeon did not include in the traditional level I - II axillary dissection, i.e., level III and supraclavicular stations. We are proposing to test a new technique that extends prone set up to also include these lymph node regions. Limiting treatment to the supraclavicular fossa and level III axilla in patients with an adequately dissected axilla is supported by several published studies. Regional nodal recurrences are rare (occurring in 1 - 5%) in patients with early stage invasive breast cancer who have undergone breast conserving therapy. Several institutions choose to treat only the level III axilla and supraclavicular nodal stations in patients who have undergone surgical treatment of level I/II axilla. This technique was documented recently by Liengsawangwong, who utilized CT-delineated nodal stations to improve target coverage of SCV (Supra-Clavicular) and level III axillary nodes in patients who had undergone axillary level I/II dissection and were found to have positive lymph nodes.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
97

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10016
        • Laura and Issac Perlmutter Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

36 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Pre- or post-menopausal women with stage II - III breast cancer (AJCC 2002)
  • Biopsy-proven invasive breast cancer, excised with negative margins of at least 1 mm
  • Status post segmental mastectomy or mastectomy and axillary node dissection with removal of at least 8 nodes
  • One to 5 involved lymph nodes identified at axillary staging
  • At least 2 weeks from last chemotherapy or before chemotherapy
  • No more than sixty days from final surgery to simulation if no systemic therapy (includes chemotherapy and Hormonal therapy) is given
  • Patient needs to be able to understand and demonstrate willingness to sign a written informed consent document

Exclusion Criteria:

  • Previous radiation therapy to the ipsilateral breast
  • More than 5 involved nodes identified at axillary staging
  • Current treatment for active connective tissue disorders, such as lupus or scleroderma
  • Pregnant or lactating women
  • Less than 35 years old

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Radiation Therapy
Radiation: Intensity-modulated radiation therapy (IMRT)
Patients will receive 15 daily radiation fractions of 2.7 Gy, Monday to Friday for three weeks, to the entire breast/chest wall and axillary level III and supraclavicular nodes with a daily concomitant boost of 0.5 Gy to the tumor bed, for a total daily dose of 3.2 Gy to the tumor bed (2.7 Gy + 0.5 Gy). The overall dose will be 40.5 Gy to the breast/chest wall, axillary level III and supraclavicular nodes, and 48.0 Gy to the tumor bed.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Number of Participants With Acute Toxicity > Grade 2 (Skin Toxicity Grade 3 or Above) Occurring Within 60 Days After First Day of Treatment
Time Frame: Day 60

"Toxicity Grading per National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE v 3.0). Please refer to the Protocol Appendix 1 for details.

Grade 1 - Mild, Grade 2 - Moderate, Grade 3 - Severe, Grade 4 - Life-threatening, Grade 5 - Death"
Day 60
Number of Participants Who Met Constraints
Time Frame: Day 60

Treatment feasibility will be evaluated for each participant by the ability to meet all physics dose constraints:

Target volume dose constraints = PTVTumor: V 48 Gy > 98%, PTVBreast: V 40.5 Gy ≥ 95%. PTVNodesEval: V 38.5 Gy > 95%.

Normal tissue dose constraints = Heart: V 5 Gy < 5%, Ipsilateral lung: V 10 Gy < 20%, Contralateral lung: V 5 Gy < 15%, Spinal cord: 37.5 Gy maximum, Spinal cord plus 0.5 cm margin: 40 Gy maximum, Thyroid: contralateral lobe 15 Gy maximum, Esophagus: V 30 Gy < 50%, 40.5 Gy maximum, Ipsilateral brachial plexus: 42 Gy maximum, Contralateral breast: Efforts should be made to keep the contralateral breast completely outside the primary beams
Day 60

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
NYU Langone Health

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Carmen Perez, M.D., NYU Laura and Issac Perlmutter Cancer Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2009

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 17, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 12, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 27, 2014

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 2, 2014

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 4, 2014

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 27, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 25, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 09-0623

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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