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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT01245712
Other study ID # 2009-0818
Secondary ID NCI-2011-01102
Status Recruiting
Phase Phase 2
First received
Last updated
Start date November 15, 2010
Est. completion date November 1, 2022

Study information

Verified date August 2018
Source M.D. Anderson Cancer Center
Contact Eric A. Strom, MD, BS
Phone 713-563-2300
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The goal of this clinical research study is to find out if receiving a 1-week course of partial breast irradiation (PBI) using proton therapy will cause fewer and/or less severe side effects (such as changes to the appearance of the breast) than a longer course of radiation treatment.

This is an investigational study. Proton radiation therapy is FDA approved and commercially available for breast cancer. Up to 200 women will take part in the study. All will be enrolled at MD Anderson.


Description:

PBI is radiation therapy given only to the area of the breast where the cancer was removed. The study staff will use proton-beam radiation to deliver the radiation therapy dose in a more targeted way than other types of radiation, so that less of the healthy tissue is affected.

Proton-Beam PBI Treatment:

If you take part in this study, you will have proton radiation therapy delivered to the area of the lumpectomy 2 times per day, at least 6 hours apart, for 5 (or rarely 6) working days in a row. You will be placed in a cradle and the beam is aimed at the area of interest. You will not feel anything when the treatment is being delivered. The treatment lasts only a few minutes, but you may be in the treatment room longer because the radiation therapists will need to make sure that you are positioned correctly and that the beam is aimed at the correct area. The study staff will show you a video that helps to explain this process.

Although you will need to be at the proton radiation center 2 times a day for your radiation therapy, you are free to leave the proton radiation center between the 2 treatments, and you should be able to do routine daily activities between treatments. This type of radiation does not stay in your body between treatments or after the final treatment.

End-of-Treatment Tests:

On the last (or next-to-last) day of proton-beam PBI, you will have the following tests performed:

- Your medical history will be recorded, and you will be asked about any side effects you have had.

- You will have a physical exam.

- You and your doctor will each fill out the questionnaire about breast changes.

- Photographs will be taken of your breasts to check the appearance of the treated breast after radiation.

At the end of radiation treatment, you will be asked how much personal time was used and how much personal money you spent during treatment. This will only take a few minutes to complete.

Length of Study:

You will receive 5 weekdays of radiation.

Your participation on the study will be over once you have completed the follow-up visits.

Follow-up Tests:

You are being asked to return to the clinic for follow-up testing for up to a total of 10 years. During the first year, there are 4 follow-up visits: about 2 weeks after treatment, about 6 weeks after treatment, about 6 months after treatment, and about 1 year after treatment. During the second and third year, you will come to the clinic every 6 months, and once a year after that for Years 4-10. Some of these visits may be completed by phone call or email.

During these follow-up visits, the following procedures will occur:

- Your medical history will be recorded, and you will be asked about any side effects you have had.

- You will have a physical exam.

- You and your doctor will each fill out the questionnaire about breast changes. This will only take a few minutes to complete.

- Photographs will be taken of your breasts to check the appearance of the treated breast after radiation.

You will have a mammogram 6 months after treatment, 1 year after treatment, and then once a year after that for up to 10 years (as part of this study). You should continue having mammograms once a year after that, as part of your normal medical follow-up and health screening.


Recruitment information / eligibility

Status Recruiting
Enrollment 200
Est. completion date November 1, 2022
Est. primary completion date November 1, 2021
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility Inclusion Criteria:

1. The patient must consent to be in the study and must have signed an approved consent form conforming with federal and institutional guidelines.

2. Patients must be >/= 18 years old. (Adenocarcinoma of the breast is not seen in children)

3. The patient must have stage 0, I, or II breast cancer. If stage II, the tumor size must be 3 cm or less.

4. On histological examination, the tumor must be DCIS or invasive adenocarcinoma of the breast.

5. Surgical treatment of the breast must have been lumpectomy. The margins of the resected specimen must be histologically free of tumor (DCIS and invasive). Reexcision of surgical margins is permitted.

6. Gross disease must be unifocal with pathologic (invasive and/or DCIS) tumor size 3 cm or less. (Patients with microscopic multifocality are eligible as long as total pathologic tumor size is 3 cm or less.)

7. Patients with invasive breast cancer are required to have axillary staging which can include sentinel node biopsy alone (if sentinel node is negative), sentinel node biopsy followed by axillary dissection or sampling with a minimum total of 6 axillary nodes (if sentinel node is positive), or axillary dissection alone (with a minimum of 6 axillary nodes). Axillary staging is not required for patients with DCIS.

8. The target lumpectomy cavity must be clearly delineated and the target lumpectomy cavity/whole breast reference volume must be less than or equal to 30% based on the postoperative/pre-enrollment CT scan.

9. Patients are eligible if, based on the postoperative CT scan, PBI is judged to be technically deliverable.

10. Patients with a history of non-breast malignancies are eligible if they have been disease-free for 5 or more years prior to enrollment and are deemed by their physician to be at low risk for recurrence. Patients with the following cancers are eligible if diagnosed and treated within the past 5 years: carcinoma in situ of the cervix, carcinoma in situ of the colon, melanoma in situ, and basal cell and squamous cell carcinoma of the skin.

Exclusion:

1. Men are not eligible for this study.

2. T2 (> 3.0 cm), T3, stage III, or stage IV breast cancer.

3. More than 3 histologically positive axillary nodes.

4. Axillary nodes with definite evidence of microscopic or macroscopic extracapsular extension.

5. Palpable or radiographically suspicious ipsilateral or contralateral axillary, supraclavicular, infraclavicular, or internal mammary nodes at time of enrollment unless there is histologic confirmation that these nodes are negative for tumor.

6. Suspicious microcalcifications, or densities (in the ipsilateral or contralateral breast as documented on mammogram or breast ultrasound) unless biopsied and found to be benign.

7. Non-epithelial breast malignancies such as sarcoma or lymphoma.

8. Proven multicentric carcinoma (invasive cancer or DCIS) in more than one quadrant or separated by 4 or more centimeters.

9. Paget's disease of the nipple.

10. Synchronous bilateral invasive or non-invasive breast cancer.

11. Surgical margins that cannot be microscopically assessed or are positive at pathologic evaluation. (If surgical margins are rendered free of disease by reexcision, the patient is eligible.)

12. Clear delineation of the extent of the target lumpectomy cavity not possible.

13. Treatment plan that includes regional nodal irradiation.

14. Prior radiation to the index breast.

15. Documented diagnosis of collagen vascular disease, specifically dermatomyositis with a CPK level above normal or with an active skin rash, systemic lupus erythematosis, or scleroderma.

16. Pregnancy or lactation at enrollment.

17. Women of reproductive potential must agree to use an effective non-hormonal method of contraception during therapy.

Study Design


Related Conditions & MeSH terms


Intervention

Radiation:
Accelerated Partial Breast Irradiation (APBI)
Two 3.4 Gy fractions administered per day, separated by at least 6 hours for a total of 34 Gy delivered in 10 fractions (5 - 6 days in a row).
Behavioral:
Questionnaires
Questionnaires completed about breast changes at baseline, end of treatment, and at each follow up visit for 10 years.
Device:
Proton Therapy System
Proton beam design will take into account day-to-day variability in treatment set-up and organ motion.

Locations

Country Name City State
United States University of Texas MD Anderson Cancer Center Houston Texas

Sponsors (1)

Lead Sponsor Collaborator
M.D. Anderson Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Patient-Reported Cosmesis Score Patient-reported cosmesis score on the Breast Cancer Treatment Outcomes Scale (BCTOS) at 1 year. Cosmesis scores range from 1 (excellent) to 4 (poor), and scores of 3 (fair) or more indicate adverse cosmetic outcomes. 1 year
Secondary Rate of CTCAE Grade 3+ Confluent Moist Desquamation Rate of CTCAE grade 3+ confluent moist desquamation estimated within 6 weeks of radiation therapy with a 90% credible interval. If we observe CTCAE grade 3+ confluent moist desquamation in only 20 patients, then our 90% credible interval will be 7% to 13%. Within 6 weeks of radiation therapy
Secondary Percent of Patients with Local Failure Percent of patients with local failure at 10 years estimated with an exact 95% confidence interval. If there is 1 patient with local failure at 10 years, and researchers have follow-up on all patients at 10 years, then the upper limit of the exact 95% confidence interval will be 2.8%. If researchers don't have 10 years of follow-up on all patients researchers will use the product-limit estimator of Kaplan and Meier (1958) to estimate the local failure rate at 10 years. 10 years
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