Partial Breast Irradiation Using Accelerated Intensity Modulated Radiotherapy

NCT00581529 | Terminated Phase 2 Results DMC

• 2 other identifiers: UMCC 2004.020IRB #2004-0459 & HUM 44980
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

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).

Conditions

Breast Cancer

Keywords

breast

Outcome Measures

Primary Outcomes (2)

• 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.

  5 years

• 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.

  5 years

Secondary Outcomes (2)

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

  not specific

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

  5 years

Study Arms (1)

Radiotherapy

EXPERIMENTAL

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

Radiation: IMRT

Interventions

IMRT RADIATION

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.

Radiotherapy

Eligibility Criteria

• Age: 40 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Michigan Rogel Cancer Center: lead

Study Sites (1)

University of Michigan

Ann Arbor, Michigan, 48109-5010, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Limitations and Caveats

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

Results Point of Contact

• Title: Dr. Lori Pierce, M.D.
• Organization: University of Michigan Comprehensive Cancer Center

ljpierce@umich.edu

734-764-9922

Study Officials

• Lori J Pierce, MD

  University of Michigan

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 20, 2007
• First Posted: December 27, 2007
• Study Start: November 1, 2004
• Primary Completion: October 1, 2010
• Study Completion: August 1, 2014
• Last Updated: October 31, 2017
• Results First Posted: August 28, 2014

Record last verified: 2017-09

Locations

US (1)