Clinical Trials /

Optimizing Preventative Adjuvant Linac-Based Radiation: the OPAL Trial - Study of Hypofractionated Partial Breast Irradiation in Women With Early Stage Breast Cancer

NCT03077841

Description:

The goal of this clinical research study is to learn about the side effects that may occur after radiation is given to breast cancer patients for 2 to 2½ weeks at the part of the breast where the disease first started. Researchers also want to learn if this treatment can help to control the disease and prevent the cancer from coming back in the breast. This is an investigational study. Radiation therapy will be delivered using FDA approved and commercially available methods. The shorter radiation treatment period is considered investigational. The study doctor can explain how radiation is designed to work. Up to 150 participants will be enrolled in this multicenter study.

Related Conditions:
  • Breast Carcinoma
  • Ductal Carcinoma In Situ
Recruiting Status:

Recruiting

Phase:

Phase 2

Trial Eligibility

Document

Title

  • Brief Title: Optimizing Preventative Adjuvant Linac-Based Radiation: the OPAL Trial - Study of Hypofractionated Partial Breast Irradiation in Women With Early Stage Breast Cancer
  • Official Title: Optimizing Preventative Adjuvant Linac-based Radiation: the OPAL Trial A Phase II Study of Hypofractionated Partial Breast Irradiation in Women With Early Stage Breast Cancer

Clinical Trial IDs

  • ORG STUDY ID: 2016-1035
  • SECONDARY ID: NCI-2017-00476
  • NCT ID: NCT03077841

Conditions

  • Malignant Neoplasm of Breast
  • Breast Cancer

Purpose

The goal of this clinical research study is to learn about the side effects that may occur after radiation is given to breast cancer patients for 2 to 2½ weeks at the part of the breast where the disease first started. Researchers also want to learn if this treatment can help to control the disease and prevent the cancer from coming back in the breast. This is an investigational study. Radiation therapy will be delivered using FDA approved and commercially available methods. The shorter radiation treatment period is considered investigational. The study doctor can explain how radiation is designed to work. Up to 150 participants will be enrolled in this multicenter study.

Detailed Description

      If you agree to take part in this study, one (1) time before you begin radiation treatment:

        -  You will complete 1 questionnaire about how your breast currently looks and feels. It
           should take about 10 minutes to complete the questionnaires.

        -  The study team will take pictures of your breast to compare the way it looks before and
           after you begin receiving radiation. Your face will be covered (as much as possible) and
           will not be included in the pictures.

      Length of Study:

      You will receive radiation for 2 to 2½ weeks. You will no longer be able to receive radiation
      if intolerable side effects occur, or if you are unable to follow study directions. Your
      participation will be over after the 5-year follow-up visit.

      Study Treatment Administration:

      If you agree to take part in this study, you will receive about 2 weeks of radiation (10
      treatments) to the part of the breast where the disease first started. If the doctor thinks
      it is needed, you will have 3 additional radiation treatments as a "boost." The boost will be
      delivered to and focus more closely on the part of the breast where the disease first
      started.

      Follow-Up Visits:

      3 weeks after you have finished receiving radiation, you will have a physical exam.

      You will return for additional follow-up visits 6 months and 1, 2, 3, 4, and 5 years after
      you have finished receiving radiation. At each visit:

        -  You will complete the study questionnaire

        -  The study team will take pictures of both of your breasts.

        -  You will have a physical exam.
    

Trial Arms

NameTypeDescriptionInterventions
Hypofractionated Partial Breast IrradiationExperimentalParticipants receive about 2 weeks of radiation (10 treatments) to the part of the breast where the disease first started. Questionnaires completed at baseline and at 6 months and 1, 2, 3, 4, and 5 years after receiving radiation.

    Eligibility Criteria

            Inclusion Criteria:
    
              1. Age 50 or older.
    
              2. Female sex.
    
              3. Diagnosis of pathologically-confirmed invasive breast cancer or ductal carcinoma in
                 situ.
    
              4. Pathologic T stage of Tis, T1, or T2 with total size of tumor < /= 3 cm (this size
                 criteria applies to both pure DCIS and invasive tumors).
    
              5. For patients with invasive breast cancer, pathologic N stage of N0, N0 (i-), or N0
                 (i+). Pathologic staging of the axilla is not required for patients with pure DCIS.
    
              6. Treatment with breast conserving surgery.
    
              7. Unifocal primary tumor based on imaging and clinical assessment. Microscopic
                 multifocality is allowed.
    
              8. Final surgical margins negative defined as no tumor on ink. Lobular carcinoma in situ
                 involving the final surgical margin will be disregarded.
    
              9. For invasive cancers, the tumor must be estrogen receptor positive (defined as 10% or
                 greater expression of estrogen receptor)
    
             10. If the patient has a history of a prior non-breast cancer, all treatment for this
                 cancer must have been completed at least one month prior to study registration and the
                 patient must have no evidence of disease for this prior non-breast cancer.
    
             11. Patients must be enrolled on the trial within 12 weeks of the later of two dates: the
                 final breast conserving surgical procedure or administration of the last cycle of
                 cytotoxic chemotherapy.
    
             12. Final criteria for eligibility established after simulation: The tumor bed can be
                 readily visualized on simulation CT and is localized to one quadrant or region of the
                 breast that is amenable to partial breast irradiation.
    
            Exclusion Criteria:
    
              1. Tumor invasion of the skin including dermis, chest wall, or pectoralis musculature.
    
              2. Any evidence of nodal positivity beyond pathologic stage of pN0(i+).
    
              3. Systemic chemotherapy prior to final breast conserving surgery.
    
              4. Patient is pregnant or nursing.
    
              5. History of therapeutic irradiation to the breast, lower neck, mediastinum or other
                 area in which there could potentially be overlap with the affected breast.
    
              6. History of prior invasive or in situ cancer in either breast.
    
              7. Current diagnosis of bilateral breast cancer.
    
              8. History of lupus or scleroderma.
          
    Maximum Eligible Age:N/A
    Minimum Eligible Age:50 Years
    Eligible Gender:Female
    Healthy Volunteers:No

    Primary Outcome Measures

    Measure:Rate of grade 2 or Higher Treatment Toxicity with Optimizing Preventative Adjuvant Linac-Based Radiation (OPAL) Regimen
    Time Frame:Toxicity measured from the start of radiation through the 6 month follow up visit.
    Safety Issue:
    Description:Toxicity during the course of radiotherapy as determined by the treating physician.

    Secondary Outcome Measures

    Measure:Patient-Reported Cosmetic Outcome with Optimizing Preventative Adjuvant Linac-Based Radiation (OPAL) Regimen
    Time Frame:Baseline and 6 months and 1, 2, 3, 4, and 5 years after receiving radiation
    Safety Issue:
    Description:Breast Cancer Treatment Outcomes Scale (BCTOS) used to score cosmetic outcome from 1 to 4, with a score of 2.5 or higher indicating adverse cosmetic outcome.

    Details

    Phase:Phase 2
    Primary Purpose:Interventional
    Overall Status:Recruiting
    Lead Sponsor:M.D. Anderson Cancer Center

    Trial Keywords

    • Malignant neoplasm of breast
    • Breast cancer
    • Radiation therapy
    • XRT
    • External beam radiation therapy
    • Shorter course
    • Questionnaires
    • Surveys

    Last Updated

    January 31, 2018