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

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ClinicalTrials.gov Identifier: NCT03077841
Recruitment Status : Recruiting
First Posted : March 13, 2017
Last Update Posted : August 17, 2018
Sponsor:
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Malignant Neoplasm of Breast Breast Cancer Radiation: External Radiation Therapy Behavioral: Questionnaires Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : March 6, 2017
Estimated Primary Completion Date : March 2020
Estimated Study Completion Date : March 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arm Intervention/treatment
Experimental: Hypofractionated Partial Breast Irradiation

Participants 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.

Radiation: External Radiation Therapy
Prescription dose is 35 Gy in 10 daily fractions delivered on consecutive treatment days. A treatment day is defined as a normal business day, typically Monday - Friday excluding institutional holidays. A 3 Gy in 3 fraction boost should be delivered if a close (less than 2 mm) margin is present and should not be delivered if margins are negative at a minimum of 2 mm or greater.
Other Names:
  • XRT
  • Hypofractionated partial breast irradiation
  • HF-PBI

Behavioral: Questionnaires
Questionnaires completed at baseline, and at 6 months and 1, 2, 3, 4, and 5 years after receiving radiation. Questionnaires ask about how participant's breast currently looks and feels. It should take about 10 minutes to complete the questionnaires.
Other Name: Surveys




Primary Outcome Measures :
  1. 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. ]
    Toxicity during the course of radiotherapy as determined by the treating physician.


Secondary Outcome Measures :
  1. 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 ]
    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.



Information from the National Library of Medicine

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, Learn About Clinical Studies.


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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03077841


Contacts
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Contact: Benjamin Smith, MD 713-563-2300 bsmith3@mdanderson.org

Locations
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United States, Indiana
Community Health Network Recruiting
Indianapolis, Indiana, United States, 46256
United States, New Jersey
Cooper University Healthcare Recruiting
Camden, New Jersey, United States, 08103
United States, Ohio
Ohio Health/Presbyterian MDA Radiation Treatment Center Recruiting
Columbus, Ohio, United States, 43228
United States, Texas
University of Texas MD Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Contact       bsmith3@mdanderson.org   
Summit Medical Group Recruiting
Houston, Texas, United States, 77051
MD Anderson Cancer Center at Bay Area Recruiting
Houston, Texas, United States, 77058
MD Anderson Cancer Center at Katy Recruiting
Houston, Texas, United States, 77094
Baptist Health Recruiting
San Antonio, Texas, United States, 78229
MD Anderson Cancer Center at Sugar Land Recruiting
Sugar Land, Texas, United States, 77478
University of Texas MD Anderson Cancer Center at The Woodlands Recruiting
The Woodlands, Texas, United States, 77384
Sponsors and Collaborators
M.D. Anderson Cancer Center
Investigators
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Principal Investigator: Benjamin Smith, MD M.D. Anderson Cancer Center

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Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT03077841     History of Changes
Other Study ID Numbers: 2016-1035
NCI-2017-00476 ( Registry Identifier: NCI CTRP )
First Posted: March 13, 2017    Key Record Dates
Last Update Posted: August 17, 2018
Last Verified: August 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by M.D. Anderson Cancer Center:
Malignant neoplasm of breast
Breast cancer
Radiation therapy
XRT
External beam radiation therapy
Shorter course
Questionnaires
Surveys
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases