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An explanatory study comparing complementary treatment to breast conservative surgery with radiation therapy DCIS, T1-T2 N0 M0 (AJCC v8) 1 week schedule vs 3.1 weeks standard schedule, in order to determine the equivalence of local tumor control, survival, acute and chronic toxicity. Shorter curse of radiation therapy may lead to similar local control of tumor cells and lower rates of toxicity than 3.1 standard treatment.
PRIMARY OBJECTIVE:
I. Compare the effectiveness of hypofractionated radiotherapy (1 week) with standard treatment (3.1 weeks) in the local control of breast cancer treated with conservative surgery.
SECONDARY OBJECTIVES:
I. Identify the histological lineage of the tumor.
II. Identify the degree of differentiation of tumor cells.
III. Identify the presence and type of receptors (estrogen, progesterone, HER-2NEU) through immunohistochemistry.
IV. Measure the frequency of progression or recurrence.
V. Identify the site of progression or recurrence.
VI. Measure the frequency of toxicity in both groups.
VII. Classify toxicity according to its severity.
VIII. Classify toxicity according to chronological presentation, acute, subacute, or chronic.
IX. Measure quality of life in both groups according to the European Organization for Research and Treatment Cancer scale, Breast Cancer-Specific Quality of Life Questionnaire, (EORTC, QLQ-BR23).
X. Measure quality of life in both groups according to the Eastern Collaborative Oncology Group (ECOG) performance scale.
XI. Measure 5-year survival.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM I: will receive radiotherapy treatment with high hypofractionation, 26 Gy in 5 fractions to the whole breast.
ARM II: will receive radiotherapy treatment with standard hypofractionation, 42.5 Gy in 16 fractions with simultaneous integrated increase of 5.5 Gy to the tumor bed in high-risk patients.
After completion of treatments, patients will be followed: 2 weeks after final fraction, 6 weeks after final fraction, every 4 months for the next 5 years
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ARM I | Experimental | Radiotherapy treatment with high hypofractionation, 26 Gy in 5 fractions to the whole breast. |
|
| ARM II | Active Comparator | Radiotherapy treatment with standard hypofractionation, 42.5 Gy in 16 fractions with simultaneous integrated increase of 5.5 Gy to the tumor bed in high-risk patients. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hypofractionated radiotherapy | Radiation | Ultra hypofractionated 26 Gy in 5 fractions applied once with daily port film. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Identify the progression timing. | Quantify the time to progression through follow up in both groups | 5 years |
| Identify the recurrence timing. | Quantify the time to recurrence through follow up in both groups | 5 years |
| Measure | Description | Time Frame |
|---|---|---|
| Identify the histological lineage of the tumor | Carcinoma InSitu or Invasive Carcinoma;
| 14 Months |
| Identify the degree of differentiation of tumor cells | Histologic grade identification using Scarff-Bloom-Richardson (SBR) scale
|
| Measure | Description | Time Frame |
|---|---|---|
| Breast Cancer-Specific Quality of Life Questionnaire, (EORTC, QLQ-BR23). | Quantify quality of life with QLQ-BR23 questionnaire created by the European Organization for Research and Treatment of Cancer Group | 5 Years |
| Measure quality of life in both groups according to the European Organization for Research and Treatment Cancer scale (ECOG) |
Inclusion Criteria:
Exclusion Criteria:
Female with ductal carcinoma in situ or early breast cancer.
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| Name | Affiliation | Role |
|---|---|---|
| Fernando H Castillo-Lopez, Phy. | Instituto Mexicano del Seguro Social | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Unidad Medica de Alta Especialidad | Mérida | Yucatán | 97150 | Mexico |
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| 14 months |
| Identify the presence and type of receptors (estrogen, progesterone, HER-2NEU) through immunohistochemistry | Number of participants with presence of Luminal A, B, HER-2NEU enriched or triple negative immunohistochemistry subtype.
| 14 months |
| Measure the frequency of toxicity in both groups. | Quantify the presence of toxicity categorized by CTCAE version 5 system.
| 5 years |
| Classify toxicity according to its severity. | Quantify toxicity according to its severity categorized by CTCAE version 5 system.
| 5 years |
Quantify quality of life with Eastern Cooperative Oncology Group (ECOG) Performance Status Scale |
| 5 Years |
| ID | Term |
|---|---|
| D002285 | Carcinoma, Intraductal, Noninfiltrating |
| D001943 | Breast Neoplasms |
| D000071960 | Breast Carcinoma In Situ |
| ID | Term |
|---|---|
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D002278 | Carcinoma in Situ |
| D018299 | Neoplasms, Ductal, Lobular, and Medullary |
| D009371 | Neoplasms by Site |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| D000069473 | Radiation Dose Hypofractionation |
| D020266 | Radiotherapy, Conformal |
| D050397 | Radiotherapy, Intensity-Modulated |
| ID | Term |
|---|---|
| D019583 | Dose Fractionation, Radiation |
| D011879 | Radiotherapy Dosage |
| D011878 | Radiotherapy |
| D013812 | Therapeutics |
| D011881 | Radiotherapy, Computer-Assisted |
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