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Trial record 1 of 1 for:    rtog and 1014
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Radiation Therapy in Treating Women With Locally Recurrent Breast Cancer Previously Treated With Repeat Breast-Preserving Surgery

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
National Cancer Institute (NCI)
NRG Oncology
Information provided by (Responsible Party):
Radiation Therapy Oncology Group
ClinicalTrials.gov Identifier:
NCT01082211
First received: March 5, 2010
Last updated: May 3, 2017
Last verified: May 2017
  Purpose

RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Giving radiation therapy after surgery kill any remaining tumor cells and may be an effective treatment for breast cancer.

PURPOSE: This phase II trial is studying how well radiation therapy works in treating women with locally recurrent breast cancer previously treated with repeat breast-conserving surgery.


Condition Intervention Phase
Breast Cancer Radiation: 3D-Conformal External Beam Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: No masking
Primary Purpose: Treatment
Official Title: A Phase II Study of Repeat Breast Preserving Surgery and 3D-Conformal Partial Breast Re-Irradiation (PBrI) for Local Recurrence of Breast Carcinoma

Resource links provided by NLM:


Further study details as provided by Radiation Therapy Oncology Group:

Primary Outcome Measures:
  • Grade 3+ Treatment-related Skin, Fibrosis, and Breast Pain Adverse Events [ Time Frame: From the end of radiation to 1 year. ]
    To evaluate the rate of grade 3+ treatment-related skin, fibrosis, and breast pain adverse events (AEs) occurring within 1 year from the completion of reirradiation. Based on a rate of 4% for these AEs, a rate of ≥ 13% for these AEs with re-irradiation would be unacceptable. A sample size of 55 evaluable pts (eligible & started protocol treatment [tx]) will provide: 86% power to conclude an unacceptable rate of the specified AEs, if the true AE rate is at least 13% & 93% probability to not conclude an unacceptable rate of the specified AEs, if the true AE rate is 4%. If ≥ 5 pts have tx-related AEs, then tx-related AE rate considered unacceptable.


Secondary Outcome Measures:
  • In-breast Recurrence [ Time Frame: From registration to date of recurrence or last follow-up. Analysis occurs after all patients have been potentially followed for 3 years. ]
    The definition of treatment failure is histologic evidence of recurrent carcinoma, either invasive or non-invasive (except LCIS) in the ipsilateral breast. Clinical evidence of carcinoma by physical examination and/or mammograms and/or MRI will not be construed as evidence of treatment failure without biopsy proof but will be considered as suspicious for recurrence. Ipsilateral breast recurrences will be considered local (infield) if they occur within the prescription isodose volume; they will be considered peripheral if they occur between the prescription isodose volume and a volume 2 cm outside of the prescription isodose volume. Ipsilateral recurrences will be considered non-contiguous or extra field if they are beyond the peripheral volume described above.

  • Freedom From Mastectomy [ Time Frame: From registration to date of mastectomy or last follow-up. Analysis occurs after all patients have been potentially followed for 3 years. ]
    Failure is mastectomy of the treated breast. Mastectomy rate at 3 years is reported, using the cumulative incidence with death as competing risk. Mastectomy-free survival is reported in outcome measure 10.

  • Rate of Circulating Tumor Cells [ Time Frame: Prior to the start of radiation and 3 weeks after last radiation treatment. ]
  • Treatment-related Adverse Events Any Time [ Time Frame: From the end of radiation to end of follow-up. Will be evaluated at the time of the primary analysis. ]
    AEs were graded with CTCAE version 4. The overall highest grade for each patient is computed from all reported adverse events definitely, probably, or possibly related to protocol treatment.

  • Cosmesis [ Time Frame: After surgery prior to the start of radiation, 1 year from the end of radiation and 3 years from the end of radiation. Analysis occurs after all patients have been potentially followed for 3 years. ]
  • Distant Metastasis-free Survival [ Time Frame: From registration to date of distant metastasis, death or last follow-up. Analysis occurs after all patient have been potentially followed for 3 years. ]
    Failures are appearance of ipsilateral axillary, infraclavicular, internal mammary, or supraclavicular recurrences; distant metastases confirmed radiographically and/or pathologically; or death due to any cause. Note that a distant metastases was only considered a treatment failure if accompanied by an in-breast recurrence.

  • Mastectomy-free Survival [ Time Frame: From registration to date of mastectomy, death or last follow-up. Analysis occurs after all patients have been potentially followed for 3 years. ]
    Failure is mastectomy of the treated breast or death due to any cause. Mastectomy-free survival rate at three years was estimated using the Kaplan-Meier method.

  • Overall Survival [ Time Frame: From registration to date of death or last follow-up. Analysis occurs after all patients have been potentially followed for 3 years. ]
    Failure is death due to any cause. Three-year overall survival rate was estimated using the Kaplan-Meier method.

  • Treatment-related Adverse Events Occurring After One Year From Completion of Re-irradiation [ Time Frame: After 1 year from the end of radiation. ]
    AEs were graded with CTCAE version 4. The overall highest grade for each patient is computed from reported adverse events definitely, probably, or possibly related to protocol treatment occurring after one year from completion of re-irradiation.


Enrollment: 65
Study Start Date: June 2010
Primary Completion Date: November 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Partial Breast Re-Irradiation
Partial Breast Re-Irradiation (PBrI) 3D-Conformal External Beam 1.5 Gy x 15 (BID) to 45 Gy Total
Radiation: 3D-Conformal External Beam
Radiation was to be delivered in 2 fractions per day, each of 1.5 Gy, separated by at least six hours, given in 15 consecutive working days to a total of 30 fractions and 45 Gy. Radiation was to be prescribed to the treatment unit isocenter, positioned at the approximate center of the planning target volume.

Detailed Description:

OBJECTIVES:

Primary

  • To evaluate skin, breast, and chest wall adverse events occurring within 1 year after completion of 3D-conformal partial-breast re-irradiation following repeat breast-preserving surgery in patients with locally recurrent breast carcinoma.

Secondary

  • To evaluate the adverse events occurring after 1 year from the completion of re-irradiation and at any time.
  • To evaluate in-breast control rate in patients treated with this regimen.
  • To evaluate freedom-from-mastectomy rate in these patients.
  • To evaluate the rate of circulating tumor cells (CTCs) in this patient population and to document eradication of CTCs by locoregional therapy.
  • To determine whether translational objective will correlate with eradication or presence of CTCs with in-breast recurrence and distant metastasis-free survival.
  • To evaluate cosmesis as judged by the patient and independent evaluation.
  • To evaluate distant metastasis-free survival, mastectomy-free survival, and overall survival of patients treated with this regimen.

OUTLINE: This is a multicenter study.

Patients undergo 3-dimensional conformal accelerated partial-breast irradiation twice daily, 5 days a week, for 3 weeks.

Some patients undergo blood sample collection at baseline and within 3 weeks after completion of radiotherapy for circulating tumor cells analysis.

Some patients complete questionnaires on cosmesis at baseline and at 1 and 3 years following radiotherapy.

After completion of study therapy, patients are followed up periodically for 4-5 years and then every year thereafter.

  Eligibility

Ages Eligible for Study:   18 Years to 120 Years   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Histologically confirmed locally recurrent breast carcinoma consistent with the following cell types:

    • Invasive ductal breast carcinoma
    • Medullary ductal breast carcinoma
    • Tubular ductal breast carcinoma
    • Mucinous ductal breast carcinoma
    • Lobular breast carcinoma
    • Ductal carcinoma in situ (DCIS)

      • No Paget disease of the nipple
    • Target lumpectomy cavity must be clearly defined and the target lumpectomy cavity/ whole-breast reference volume must be < 30% based on a post-operative, pre-treatment CT scan
    • Tumor size ≤ 3 cm in greatest dimension on pathologic specimen
    • Negative histologic margins of resection and no tumor on ink following breast-preserving surgery of local recurrence (Re-excision is permitted to achieve negative margins)
    • Axilla negative or ≤ 3 positive lymph nodes without extracapsular extension
    • If the in-breast recurrence is DCIS and/or microinvasive disease, a sentinel lymph node (SLN) evaluation is not required, but if performed:
    • Patients with a negative sentinal lymph node (SLN) biopsy are eligible for enrollment
    • Patients with a positive SLN biopsy require an axillary lymph node (ALN) dissection (ALND is not required if the SLN is not identified)
    • Patient is eligible if 0-3 positive ALNs without extracapsular extension is documented
  • If the in-breast recurrence is invasive disease and:

    • No prior ALN dissection or SLN dissection only:

      • Patient is required to undergo axillary evaluation with either a SLN or ALN dissection
      • If the SLN is not identified or if the SLN is positive for metastatic disease then an ALN dissection is required
      • Patient is eligible for enrollment if encounter 0-3 positive lymph nodes without extracapsular extension
    • • Prior ALN dissection: negative clinical exam: patient is eligible for enrollment

      • It is recommended, but not required, that the patient undergo ultrasound evaluation of the axilla and the lymph node draining regions of the breast; any suspicious areas are to be biopsied and if positive followed with an ALN dissection
      • Patient is eligible for enrollment if biopsies are negative or 0-3 axillary lymph nodes without extracapsular extension are encountered
    • Prior ALN dissection: positive clinical exam: biopsy required

      • If biopsy is negative, patient is eligible for enrollment
      • If biopsy is positive an ALN dissection is required
      • Patient is eligible for enrollment if biopsies are negative or 0-3 axillary lymph nodes without extracapsular extension encountered
  • Ipsilateral breast mammogram and MRI within 120 days prior to study entry
  • Contralateral breast mammogram within 12 months of study entry
  • For invasive in-breast recurrence, no more than 120 days since whole-body (positron emission tomography) PET-CT scan OR CT scan of the chest, abdomen, and pelvis, and bone scan
  • No multicentric ipsilateral breast recurrence or regional recurrence (other than axilla)
  • Patients must have a breast technically amenable to partial-breast irradiation
  • No metastatic disease documented by physical exam or radiographic evaluation (for patients with invasive disease)
  • No skin involvement
  • No prior contralateral mastectomy
  • Estrogen and progesterone status must be known

PATIENT CHARACTERISTICS:

  • Zubrod performance status 0-1
  • Menopausal status not specified
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • No other invasive malignancy within the past 3 years except ipsilateral breast cancer and/or nonmelanoma skin cancer
  • No collagenous diseases, specifically systemic lupus erythematosus, scleroderma, or dermatomyositis
  • No psychiatric or addictive disorders that would preclude obtaining informed consent

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
  • More than 2 weeks since prior chemotherapy and recovered
  • No concurrent intensity-modulated radiotherapy
  • No concurrent chemotherapeutic agents, including trastuzumab
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01082211

  Show 58 Study Locations
Sponsors and Collaborators
Radiation Therapy Oncology Group
National Cancer Institute (NCI)
NRG Oncology
Investigators
Principal Investigator: Douglas W. Arthur, MD Massey Cancer Center
  More Information

Responsible Party: Radiation Therapy Oncology Group
ClinicalTrials.gov Identifier: NCT01082211     History of Changes
Other Study ID Numbers: RTOG 1014
CDR0000666991
Study First Received: March 5, 2010
Results First Received: May 3, 2017
Last Updated: May 3, 2017

Keywords provided by Radiation Therapy Oncology Group:
invasive ductal breast carcinoma
medullary ductal breast carcinoma with lymphocytic infiltrate
invasive lobular breast carcinoma
tubular ductal breast carcinoma
mucinous ductal breast carcinoma
ductal breast carcinoma in situ
lobular breast carcinoma in situ
recurrent breast cancer

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

ClinicalTrials.gov processed this record on July 21, 2017