Study of Prone Accelerated Breast And Nodal IMRT

NCT02308488 | Completed Results DMC FDA Device

• 1 other identifier: 09-0623
• Study Type: interventional
• Target: 97
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Lymphedema

Keywords

prone IMRT to breast, level III & Supraclavicular; acute toxicity of prone IMRT to breast, level III & SCV

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (1)

Radiation Therapy

EXPERIMENTAL

Radiation: Intensity-modulated radiation therapy (IMRT)

Interventions

Intensity-modulated radiation therapy (IMRT) RADIATION

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.

Radiation Therapy

Eligibility Criteria

• Age: 36 Years - 90 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• NYU Langone Health: lead

Study Sites (1)

Laura and Issac Perlmutter Cancer Center

New York, New York, 10016, United States

Location

MeSH Terms

Conditions

Lymphedema

Interventions

Radiotherapy, Intensity-Modulated

Condition Hierarchy (Ancestors)

Lymphatic Diseases; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Radiotherapy, Conformal; Radiotherapy, Computer-Assisted; Radiotherapy; Therapeutics

Results Point of Contact

• Title: Carmen A. Perez, M.D., Ph.D.
• Organization: NYU Langone Health - Perlmutter Cancer Center

Carmen.Perez@nyulangone.org

212-731-5003

Study Officials

• Carmen Perez, M.D.

  NYU Laura and Issac Perlmutter Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 27, 2014
• First Posted: December 4, 2014
• Study Start: September 1, 2009
• Primary Completion: September 17, 2021
• Study Completion: October 12, 2021
• Last Updated: April 27, 2023
• Results First Posted: August 2, 2022

Record last verified: 2023-04

Locations

US (1)