Proton Radiation for Stage III Breast Cancer

This study is currently recruiting participants.
Verified February 2014 by Proton Collaborative Group
Sponsor:
Information provided by (Responsible Party):
Proton Collaborative Group
ClinicalTrials.gov Identifier:
NCT01758445
First received: December 14, 2012
Last updated: February 19, 2014
Last verified: February 2014
  Purpose

The purpose of this study is to look at the rates of acute and long term adverse events of postoperative proton radiotherapy for complex loco-regional irradiation in women with loco-regionally advanced breast cancer. This study specifically includes longitudinal follow up to assess the incidence of cardiac mortality and second malignant neoplasms at 10 and 15 years following proton therapy(PT).


Condition Intervention Phase
Breast Cancer
Breast Neoplasm
Breast Tumor
Cancer of the Breast
Radiation: Proton Radiotherapy
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase II Study of Postoperative, Cardiac-Sparing Proton Radiotherapy for Women With Stage III,Loco-Regional, Non-Metastatic Breast Cancer

Resource links provided by NLM:


Further study details as provided by Proton Collaborative Group:

Primary Outcome Measures:
  • Determination of the rates of acute and late toxicities (acute and late adverse events) resulting from proton therapy radiation treatment. [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Compare dosimetrically the dose volume histogram (DVH) of the PT plans with conventional external beam plans (either photon/electron intensity modulated radiotherapy(IMRT)plans, 3D-photon plans, or Tomotherapy plans). [ Time Frame: On average at 9 weeks post start of treatment ] [ Designated as safety issue: No ]
  • Incidence rates of local control, regional control, metastatic status and disease free overall survival. [ Time Frame: 5 years ] [ Designated as safety issue: No ]
  • Compare the different DVH parameters for the targets (D2, Dmean, Dmin, D95, V95, V110) and different OARs (as described later) of the PT plans with the corresponding values of the 3D-conformal radiation therapy (CRT), IMRT and Tomotherapy plans. [ Time Frame: On average at 9 weeks post start of treatment ] [ Designated as safety issue: No ]
  • Determine dose distribution of proton therapy to coronary arteries, heart, ipsilateral and contralateral lung, and contralateral breast. [ Time Frame: On average at 9 weeks post start of treatment ] [ Designated as safety issue: No ]
  • Determine the incidence of clinically symptomatic coronary artery disease, cardiac morbidity and mortality in general and incidence of secondary malignancy, including contralateral breast cancer [ Time Frame: 5 years ] [ Designated as safety issue: No ]
  • Evaluate quality of life results. [ Time Frame: 5 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 500
Study Start Date: February 2013
Estimated Study Completion Date: January 2030
Estimated Primary Completion Date: January 2022 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Proton Radiotherapy Radiation: Proton Radiotherapy
Radiation therapy will be given once a day. Minimum of 28 treatments and may receive 6-9 additional treatments as determined by protocol & physician.

Detailed Description:

The proposed Phase II study is seeking to build clinical data as a continuation of the original dosimetric analysis published by Ares et al. performed at Paul-Scherrer Institute (PSI). That comparison demonstrated a benefit form proton planning for patients with non-metastatic breast cancer requiring complex, loco-regional, postoperative radiotherapy.1 The advantages of PT were improved target coverage compared to standard photon irradiation and reduced dose to heart, lungs and contralateral breast.

The study goal is to demonstrate a "meaningful benefit" of proton therapy for women with loco-regionally advanced breast cancer. The main clinical endpoints of this trial are the reduction of cardiac morbidity and mortality (coronary artery disease, myocardial infarction, cardiac insufficiency) and the reduction of contralateral, second breast cancer. Both adverse events are presently associated with external beam photon therapy. Both goals require longitudinal follow-up of minimum 5-10 years. Despite the logistical challenges of long term follow-up, the effort is needed in view of the compelling preclinical evidence of dose avoidance or even absence of radiation dose to heart and contralateral breast uniquely accomplishable by protons only.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Must sign study-specific, institutional review board (IRB) approved informed consent form prior to study entry. Note consent by legally authorized representative is not allowed for this trial.
  • Must be female.
  • Must be > = 18 years of age.
  • Must have a life expectancy of at least 10 years based on age and co-morbidities but excluding diagnosis of breast cancer.
  • Must have pathology proven breast cancer. Pathology must be invasive ductal or lobular carcinoma of the breast.
  • Must meet stage III group criteria per American Joint Committee on Cancer (AJCC) Staging manual 7th edition (see appendix II).
  • Must be treated with proton therapy within 9 weeks after last surgery for breast cancer (lumpectomy, re-excision of margins, axillary staging procedure or mastectomy) OR if chemotherapy is given, it must be finished at least 2 weeks and not later than 8 weeks prior to PT.
  • Must have had surgical treatment of the breast - either modified radical mastectomy or lumpectomy. Re-excision of surgical margins is permitted.

Exclusion Criteria:

  • Weight over 410 pounds.
  • Non-epithelial breast malignancies such as sarcoma or lymphoma.
  • Synchronous multifocal or bilateral invasive or non-invasive breast cancer.
  • Surgical margins that cannot be microscopically assessed or are positive at pathologic evaluation. (If surgical margins are rendered free of disease by re-excision, the patient is eligible).
  • Evidence of contralateral breast cancer that would require contralateral adjuvant radiotherapy.
  • Breast size exceeding the technical limitation of daily set-up reproducibility. This may be center-specific and will be assessed at the discretion of the treating center.
  • Women with post-surgical temporary breast expanders will require individual assessment. Depending on the manufacturing product and other treatment planning-specific details the patient may be eligible or may be deemed ineligible, as determined by treating investigator.
  • Prior history of breast cancer.
  • Paget's disease of the nipple.
  • Prior radiation to the breast or thorax.
  • Collagen vascular disease, specifically dermatomyositis with a Creatine phosphokinase (CPK)level above normal or with an active skin rash, systemic lupus erythematosis, or scleroderma.
  • Pregnancy or lactation at the time of proposed study entry. Women of reproductive potential must agree to use an effective non-hormonal method of contraception during therapy such as an intrauterine device or condom with spermicide.
  • Psychiatric or addictive disorders or other conditions that, in the opinion of the investigator, would preclude the patient from meeting the study requirements.
  • Prior history of non-breast malignancies unless they have been disease free for 5 or more years and are deemed by their physician to be at low risk for recurrence. Further, patients who have the following cancers treated within the prior 5 years are permitted: carcinoma in situ of the cervix, carcinoma in situ of the colon, melanoma in situ, basal cell or squamous cell carcinoma of the skin.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01758445

Contacts
Contact: Megan Dunn, PhD,MSHS 630-657-0092 mdunn@pcgresearch.org

Locations
United States, Illinois
CDH Proton Center Recruiting
Warrenville, Illinois, United States, 60555
Contact: Corey Woods, RN,MS, CCRC    630-821-6397    corey.woods@chi.procure.com   
Principal Investigator: Paige Dorn, MD         
United States, New Jersey
Princeton ProCure Managment LLC Recruiting
Somerset, New Jersey, United States, 08873
Contact: Carl Brown    732-357-2676    Carl.Brown@nj.procure.com   
Principal Investigator: Eugen Hug, MD         
United States, Oklahoma
Procure Proton Therapy Center Recruiting
Oklahoma City, Oklahoma, United States, 73142
Contact: Tish Adams, MS CCRC    405-773-6775    tish.adams@okc.procure.com   
Sponsors and Collaborators
Proton Collaborative Group
Investigators
Study Chair: Eugen Hug, MD Proton Collaborative Group
  More Information

No publications provided

Responsible Party: Proton Collaborative Group
ClinicalTrials.gov Identifier: NCT01758445     History of Changes
Other Study ID Numbers: BRE008-12
Study First Received: December 14, 2012
Last Updated: February 19, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Proton Collaborative Group:
Breast
Cancer
Radiation
Proton

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases

ClinicalTrials.gov processed this record on April 17, 2014