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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2020-04328 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| MC1935 | Other Identifier | Mayo Clinic in Arizona | |
| 19-008858 | Other Identifier | Mayo Clinic Institutional Review Board |
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This phase III trial compares the rate of complications of x-ray therapy versus proton beam radiation therapy after breast conserving surgery or mastectomy in treating patients with breast cancer. X-ray therapy is a form of radiation therapy that uses high-energy radiation from x-rays to kill tumor cells and shrink tumors. Proton beam radiation therapy is a type of radiation therapy that uses high-energy beams to treat tumors. It is not yet known what level of complications x-ray therapy or proton beam radiation therapy have in treating patients with breast cancer.
PRIMARY OBJECTIVE:
I. To determine the 24-month complication rate of 5 fraction radiotherapy compared to 25 fraction radiotherapy.
SECONDARY OBJECTIVES:
I. To evaluate acute toxicity that occur up to 12 months after radiation. II. To evaluate late toxicity that appear or persist 12 months after radiation. III. To estimate the 5-year locoregional control, invasive disease-free survival, disease-free survival, cause-specific survival and overall survival.
CORRELATIVE AND EXPLORATORY OBJECTIVES:
I. To evaluate patient-reported quality of life outcomes through Mayo Breast Survey, Mayo 10 (Patient-Reported Outcomes [PRO]-Common Terminology Criteria for Adverse Events [CTCAE]), and Mayo Patient Survey.
II. To evaluate clinical features, treatment technique, dose-volume parameters, histologic and genetic variants associated with fair and poor cosmetic outcomes or unplanned surgical intervention.
III. To evaluate the costs and comparative effectiveness of treatment. IV. Compare the use of photon therapy with spot scanning proton therapy hypo-fractionated whole breast or post-mastectomy chest wall with regional nodal irradiation.
V. To evaluated cosmetic outcome with patient-reported measures with elements from the Mayo Breast Patient Survey and panel assess cosmetic outcome with blinded photographs, and the Harvard/National Surgical Adjuvant Breast and Bowel Project (NSABP)/Radiation Therapy Oncology Group (RTOG) Cosmesis Scale.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM I: Within 12 weeks of the last breast cancer surgery or last dose of adjuvant chemotherapy and no sooner than 14 days since the last chemotherapy, patients undergo x-ray therapy over 25 fractions in the absence of disease progression or unacceptable toxicity. Optionally, patients may then receive a 4-fraction boost of x-ray therapy.
ARM II: Within 12 weeks of the last breast cancer surgery or last dose of adjuvant chemotherapy and no sooner than 14 days since the last chemotherapy, patients undergo proton beam radiation therapy over 5 fractions in the absence of disease progression or unacceptable toxicity. Optionally, patients may receive a concurrent 5-fraction boost of proton beam radiation therapy.
After completion of study treatment, patients are followed up at 12 weeks, at 6, 12, 24, and 36 months, and then at 5 years.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm I (x-ray therapy) | Experimental | Within 12 weeks of the last breast cancer surgery or last dose of adjuvant chemotherapy and no sooner than 14 days since the last chemotherapy, patients undergo x-ray therapy over 25 fractions in the absence of disease progression or unacceptable toxicity. Optionally, patients may then receive a 4-fraction boost of x-ray therapy. |
|
| Arm II (proton beam radiation therapy) | Experimental | Within 12 weeks of the last breast cancer surgery or last dose of adjuvant chemotherapy and no sooner than 14 days since the last chemotherapy, patients undergo proton beam radiation therapy over 5 fractions in the absence of disease progression or unacceptable toxicity. Optionally, patients may receive a concurrent 5-fraction boost of proton beam radiation therapy. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Proton Beam Radiation Therapy | Radiation | Undergo proton beam radiation therapy |
|
| Measure | Description | Time Frame |
|---|---|---|
| Complication rate | Will be defined as the percentage of women evaluable at 24 months who develop one or more of these events: grade 3 or higher late adverse event or unplanned surgeries for cosmetic or treatment related events, including surgeries to remove implant. | At 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of acute adverse events | The maximum grade for each type of acute adverse event will be recorded for each patient. Data will be summarized as frequencies and relative frequencies by treatment arm. Additionally, the relationship of the adverse event(s) to the study treatment will be taken into consideration. Rates will be compared between arms using chi-squared tests. | Up to 12 months post-radiation therapy |
| Measure | Description | Time Frame |
|---|---|---|
| Cosmetic outcome | Will compare cosmetic outcome with patient self-reported and panel-assessed cosmetic outcome measures to include elements from the Mayo Breast Patient Survey, blinded photograph assessment, the modified Harvard/National Surgical Adjuvant Breast and Bowel Project/Radiation Therapy Oncology Group Cosmesis Scale, and the Breast Cancer Treatment Outcome Scale. Will be summarized with the frequencies and confidence intervals of fair or poor cosmesis events at baseline, 2 years, and 5 years by treatment arm. Comparisons between arms will employ chi-squared tests. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Carlos E. Vargas, M.D. | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic in Arizona | Scottsdale | Arizona | 85259 | United States | ||
| Mayo Clinic in Florida |
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| Label | URL |
|---|---|
| Mayo Clinic Clinical Trials | View source |
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Panel-assessed cosmetic outcome
| Questionnaire Administration | Other | Ancillary studies |
|
| X-ray Therapy | Radiation | Undergo x-ray therapy |
|
|
| Incidence of late toxicity | Will be defined as any adverse event that occurred or persisted after the first 12 months post-radiation therapy and up to 5 years post-radiation therapy. The maximum grade for each type of late adverse event will be recorded for each patient. Data will be summarized as frequencies and relative frequencies by treatment arm. Additionally, the relationship of the adverse event(s) to the study treatment will be taken into consideration. Rates will be compared between arms using chi-squared tests. | Up to 5 years post-radiation therapy |
| Locoregional control | The cumulative incidence of locoregional recurrence will be estimated using a competing risks method by treatment arm. The competing risks will be distant breast cancer recurrence and death. Comparison between arms will employ Fine-Gray regression. | Up to 5 years post-radiation therapy |
| Invasive disease-free survival | Invasive disease recurrence is defined by ipsilateral breast tumor recurrence (IBTR), regional recurrence, or distant recurrence. Will be estimated with a Kaplan-Meier estimator and curve by treatment arm. Estimates will be given for specific time points along with 95% confidence intervals. Comparison between arms will employ a log-rank test. | From study registration until the time of invasive disease recurrence (not including ductal carcinoma in situ) or death due to any cause, assessed up to 5 years post-radiation therapy |
| Disease-free survival | Defined as the time from registration until the time of disease recurrence or death due to any cause. Will be estimated with a Kaplan-Meier estimator and curve by treatment arm. Estimates will be given for specific time points along with 95% confidence intervals. Comparison between arms will employ a log-rank test. | Up to 5 years post-radiation therapy |
| Cause-specific survival | Will be estimated with a Kaplan-Meier estimator and curve by treatment arm. Estimates will be given for specific time points along with 95% confidence intervals. Comparison between arms will employ a log-rank test. | Up to 5 years post-radiation therapy |
| Overall survival | Defined as the time from registration to death due to any cause. Will be estimated with a Kaplan-Meier estimator and curve by treatment arm. Estimates will be given for specific time points along with 95% confidence intervals. Comparison between arms will employ a log-rank test. | Up to 5 years post-radiation therapy |
| Up to 5 years post-radiation therapy |
| Jacksonville |
| Florida |
| 32224-9980 |
| United States |
| Mayo Clinic in Rochester | Rochester | Minnesota | 55905 | United States |
| ID | Term |
|---|---|
| D061766 | Proton Therapy |
| D011522 | Protons |
| D014964 | X-Ray Therapy |
| ID | Term |
|---|---|
| D063193 | Heavy Ion Radiotherapy |
| D011878 | Radiotherapy |
| D013812 | Therapeutics |
| D002414 | Cations, Monovalent |
| D002412 | Cations |
| D007477 | Ions |
| D004573 | Electrolytes |
| D007287 | Inorganic Chemicals |
| D006859 | Hydrogen |
| D004602 | Elements |
| D005740 | Gases |
| D000071940 | Nucleons |
| D004601 | Elementary Particles |
| D055585 | Physical Phenomena |
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