Study of Prone Accelerated Breast And Nodal IMRT

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: Completed
• Conditions: Lymphedema
• Intervention / Treatment: Radiation: Intensity-modulated radiation therapy (IMRT)

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: Interventional
• Enrollment (Actual): 97
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

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

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	"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	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

• Sponsor: NYU Langone Health
• Investigators: Principal Investigator: Carmen Perez, M.D., NYU Laura and Issac Perlmutter Cancer Center

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2009
• Primary Completion (Actual): September 17, 2021
• Study Completion (Actual): October 12, 2021

Study Registration Dates

• First Submitted: October 27, 2014
• First Submitted That Met QC Criteria: December 2, 2014
• First Posted (Estimate): December 4, 2014

Study Record Updates

• Last Update Posted (Actual): April 27, 2023
• Last Update Submitted That Met QC Criteria: April 25, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Keywords: prone IMRT to breast, level III & Supraclavicular; acute toxicity of prone IMRT to breast, level III & SCV
• Additional Relevant MeSH Terms: Lymphatic Diseases; Lymphedema
• Other Study ID 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