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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2020-05711 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| Pro2020001306 | |||
| 042005 | Other Identifier | Rutgers Cancer Institute of New Jersey | |
| P30CA072720 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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This phase II trial investigates the safety of delivering a part (boost) of radiation treatment before breast surgery in treating patients with breast cancer that has not spread to other places in the body (non-metastatic). Radiation therapy uses high energy photons/electrons to kill tumor cells and shrink tumors. Delivering a boost radiation treatment before surgery when doctors can still visualize the tumor on imaging may help to better target the tumor and decrease the volume of normal irradiated tissue. By so doing, doctors may achieve better cosmetic outcomes and possibly better tumor control.
PRIMARY OBJECTIVE:
I. To demonstrate that the incidence of grade 3 or more wound complications in patients with non-metastatic node negative breast cancer who are eligible for breast conserving surgery (BCS) and treated with pre-operative radiation boost at 1 month after end of whole breast radiation is no worse than the rates in the current standard of care (6-20%).
SECONDARY OBJECTIVE:
I. To demonstrate that the physician reported cosmetic outcome at 1 and 3 years after the end of treatment is better than what has been reported for the current standard of practice for patients undergoing BCS and hypofractionated whole breast irradiation (WBI).
TERTIARY/EXPLORATORY OBJECTIVES:
I. To measure the acute and late radiation related toxicities such as radiation dermatitis, telangiectasia and fibrosis in this cohort of patients.
II. To measure the pre-operative boost clinical target volume (CTV) and compare to the post-op CTV volume that would have been contoured as CTV if the boost was to be delivered post-operatively.
III. To measure the incidence of fair/poor patient reported cosmetic outcome using the Breast Cancer Treatment Outcomes Scale (BCTOS) cosmetic scale.
IV. To study the cancer biology before and after radiation treatment.
OUTLINE:
Prior to surgery, patients undergo radiation therapy boost over 4 fractions. Patients then undergo standard of care surgery 1-3 weeks from the last day of boost. 3 to 5 weeks after surgery, patients continue standard of care WBI in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up at 1, 3, 6, 9, 12, 18, and 24 months
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment (radiation therapy boost, WBI) | Experimental | Prior to surgery, patients undergo radiation therapy boost over 4 fractions. Patients then undergo standard of care surgery 1-3 weeks from the last day of boost. 3 to 5 weeks after surgery, patients continue standard of care WBI in the absence of disease progression or unacceptable toxicity. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Quality-of-Life Assessment | Other | Ancillary studies |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in wound status from baseline every 3-6 months after WBI to access incidence of grade 3 or more wound complications after breast conserving surgery. | Wound complications will be assessed by the surgeon and radiation oncologist and graded using descriptions and grading scales found in the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events version 5 (CTCAE v 5.0). This will be calculated as a proportion based on the number of events in the study. Will report the proportion with a 95% confidence interval (CI) using the Clopper-Pearson method. | For at least 36 months after WBI |
| Measure | Description | Time Frame |
|---|---|---|
| Physician reported cosmesis | Physician reported cosmesis will be assessed using the Harvard Cosmesis assessment Scale for Breast Cancer Patients which is a 4-point scale describing the breast cosmetic outcome (excellent, good, fair or poor). | At 1 month after whole breast irradiation (WBI) |
| Physician reported cosmesis |
| Measure | Description | Time Frame |
|---|---|---|
| Acute and late radiation toxicity | Rate of fibrosis, rate of telangiectasia formation and rate of radiation dermatitis will be assessed by the radiation oncologist using descriptions and grading scales found in the NCI CTCAE v5.0. Will also assess changes in pathology between the biopsy and the surgical specimen. | Up to 24 months after WBI |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bruce G Haffty | Rutgers Cancer Institute of New Jersey | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clara Maass Medical Center | Belleville | New Jersey | 07109 | United States | ||
| RWJBarnabas Health-Trinitas Hospital and Comprehensive Care |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 3, 2023 |
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| Questionnaire Administration | Other | Ancillary studies |
|
| Radiation Boost | Radiation | Undergo radiation therapy boost |
|
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| Therapeutic Surgical Procedure | Procedure | Undergo standard surgery |
|
| Whole Breast Irradiation | Radiation | Undergo standard WBI |
|
| Breast MRI | Other | A baseline breast MRI |
|
Physician reported cosmesis will be assessed using the Harvard Cosmesis assessment Scale for Breast Cancer Patients which is a 4-point scale describing the breast cosmetic outcome (excellent, good, fair or poor). |
| At 12 months after WBI |
| Physician reported cosmesis | Physician reported cosmesis will be assessed using the Harvard Cosmesis assessment Scale for Breast Cancer Patients which is a 4-point scale describing the breast cosmetic outcome (excellent, good, fair or poor). Will be reported as a proportion; CI will be calculated using the Clopper-Pearson model. | At 36 months after WBI |
| Patient reported cosmesis |
Patient reported cosmesis will be assessed by the patient using the Breast Cancer Treatment Outcomes Scale (BCTOS). |
| At 1 month after WBI |
| Patient reported cosmesis | Patient reported cosmesis will be assessed by the patient using the Breast Cancer Treatment Outcomes Scale (BCTOS). Breast Cancer Treatment Outcome Scale is a questionnaire designed to assess women's subjective evaluation of both the aesthetic and functional outcome after breast cancer treatment. Patients are instructed to rate each item of the BCTOS questionnaire on a four-point scale evaluating the differences between the treated and the untreated breast (1 = no difference to 4 = large difference). Higher scores reflect worse outcomes. | At 12 months after WBI |
| Patient reported cosmesis | Patient reported cosmesis will be assessed by the patient using the Breast Cancer Treatment Outcomes Scale (BCTOS). Breast Cancer Treatment Outcome Scale is a questionnaire designed to assess women's subjective evaluation of both the aesthetic and functional outcome after breast cancer treatment. Patients are instructed to rate each item of the BCTOS questionnaire on a four-point scale evaluating the differences between the treated and the untreated breast (1 = no difference to 4 = large difference). Higher scores reflect worse outcomes. | At 24 months after WBI |
| Clinical target volume (CTV) | The difference between the pre-operative boost Clinical target volume (CTV) and the post-op Clinical target volume (CTV) volume that would have been contoured as Clinical target volume (CTV) if the boost was to be delivered post-operatively. | Measured 1-5 weeks prior to surgery and measured 1-7 weeks after surgery |
| Tumor histology and pathologic response | Another goal is to look into the histopathology of tumors before and after radiation to assess response and other immunologic changes to the tumor and the tumor environment elicited by the radiation treatment. | Up to 24 months after WBI |
| Elizabeth |
| New Jersey |
| 07202 |
| United States |
| The Cancer Institute of New Jersey Hamilton | Hamilton | New Jersey | 08690 | United States |
| RWJBarnabas Health Jersey City Medical Center | Jersey City | New Jersey | 07302 | United States |
| RWJBarnabas Health - Monmouth Medical Center Southern Campus | Lakewood | New Jersey | 08701 | United States |
| Cooperman Barnabas Medical Center (Saint Barnabas Medical Center) | Livingston | New Jersey | 07039 | United States |
| Rutgers Cancer Institute of New Jersey | New Brunswick | New Jersey | 08903 | United States |
| Rutgers New Jersey Medical School | Newark | New Jersey | 07101 | United States |
| RWJBarnabas Health - Newark Beth Israel Medical Center | Newark | New Jersey | 07112 | United States |
| Robert Wood Johnson University Hospital Somerset | Somerville | New Jersey | 08876 | United States |
| RWJBarnabas Health - Community Medical Center | Toms River | New Jersey | 08755 | United States |
| Jan 4, 2024 |
| Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jul 5, 2023 | Jan 4, 2024 | ICF_001.pdf |
| ID | Term |
|---|---|
| D000071960 | Breast Carcinoma In Situ |
| ID | Term |
|---|---|
| D002278 | Carcinoma in Situ |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D001943 | Breast Neoplasms |
| D009371 | Neoplasms by Site |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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