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Following consent, patients will receive 15 fractions of radiotherapy to the affected breast and to Axillary level III and SCV (Supra-Clavicular) lymph nodes, defined by CT imaging obtained in a prone position using IMRT(intensity modulation radiation therapy ) technique: one fraction daily for 5 days/week for 3 consecutive weeks. Patients will be seen for follow-up at 45-60 days from first radiotherapy treatment, and then yearly. Patients will be assessed for Lymphedema at baseline, end of treatment, and at yearly intervals after completion of radiotherapy. All patients will be followed for toxicity and outcome (local and systemic recurrence, survival). In addition, patients will complete a self-assessment of QOL at baseline, week 3, day 45-60 and 2-yr follow-ups.
A recent Cochrane Collaboration Intervention Review has addressed the effects of altered fractionation size on women with early breast cancer who have undergone breast conservation surgery. Analysis of two prospective randomized trials that included 2644 women, selected based on tumor size less than five cm, negative pathological margin of excision and negative lymph nodes. No difference in clinical outcome was detected. The conclusion of the review is that the use of unconventional fractionation regimens (greater than 2 Gy per fraction) does not affect breast appearance or toxicity, and does not seem to affect local recurrence or five years survival rates.
After breast surgery and an adequate axillary dissection (i.e., at least 8 nodes retrieved in the axillary dissection specimen from level I and II) it is possible to identify patients with 1 - 5 positive nodes who require radiotherapy to both the indexed breast/chest wall and the draining nodal stations that the surgeon did not include in the traditional level I - II axillary dissection, i.e., level III and supraclavicular stations. We are proposing to test a new technique that extends prone set up to also include these lymph node regions. Limiting treatment to the supraclavicular fossa and level III axilla in patients with an adequately dissected axilla is supported by several published studies. Regional nodal recurrences are rare (occurring in 1 - 5%) in patients with early stage invasive breast cancer who have undergone breast conserving therapy. Several institutions choose to treat only the level III axilla and supraclavicular nodal stations in patients who have undergone surgical treatment of level I/II axilla. This technique was documented recently by Liengsawangwong, who utilized CT-delineated nodal stations to improve target coverage of SCV (Supra-Clavicular) and level III axillary nodes in patients who had undergone axillary level I/II dissection and were found to have positive lymph nodes.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Radiation Therapy | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intensity-modulated radiation therapy (IMRT) | Radiation | Patients will receive 15 daily radiation fractions of 2.7 Gy, Monday to Friday for three weeks, to the entire breast/chest wall and axillary level III and supraclavicular nodes with a daily concomitant boost of 0.5 Gy to the tumor bed, for a total daily dose of 3.2 Gy to the tumor bed (2.7 Gy + 0.5 Gy). The overall dose will be 40.5 Gy to the breast/chest wall, axillary level III and supraclavicular nodes, and 48.0 Gy to the tumor bed. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Acute Toxicity > Grade 2 (Skin Toxicity Grade 3 or Above) Occurring Within 60 Days After First Day of Treatment | "Toxicity Grading per National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE v 3.0). Please refer to the Protocol Appendix 1 for details. Grade 1 - Mild, Grade 2 - Moderate, Grade 3 - Severe, Grade 4 - Life-threatening, Grade 5 - Death" | Day 60 |
| Number of Participants Who Met Constraints | Treatment feasibility will be evaluated for each participant by the ability to meet all physics dose constraints: Target volume dose constraints = PTVTumor: V 48 Gy > 98%, PTVBreast: V 40.5 Gy ≥ 95%. PTVNodesEval: V 38.5 Gy > 95%. Normal tissue dose constraints = Heart: V 5 Gy < 5%, Ipsilateral lung: V 10 Gy < 20%, Contralateral lung: V 5 Gy < 15%, Spinal cord: 37.5 Gy maximum, Spinal cord plus 0.5 cm margin: 40 Gy maximum, Thyroid: contralateral lobe 15 Gy maximum, Esophagus: V 30 Gy < 50%, 40.5 Gy maximum, Ipsilateral brachial plexus: 42 Gy maximum, Contralateral breast: Efforts should be made to keep the contralateral breast completely outside the primary beams | Day 60 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Carmen Perez, M.D. | NYU Laura and Issac Perlmutter Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Laura and Issac Perlmutter Cancer Center | New York | New York | 10016 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Radiation Therapy | Intensity-modulated radiation therapy (IMRT): Patients will receive 15 daily radiation fractions of 2.7 Gy, Monday to Friday for three weeks, to the entire breast/chest wall and axillary level III and supraclavicular nodes with a daily concomitant boost of 0.5 Gy to the tumor bed, for a total daily dose of 3.2 Gy to the tumor bed (2.7 Gy + 0.5 Gy). The overall dose will be 40.5 Gy to the breast/chest wall, axillary level III and supraclavicular nodes, and 48.0 Gy to the tumor bed. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Radiation Therapy | Intensity-modulated radiation therapy (IMRT): Patients will receive 15 daily radiation fractions of 2.7 Gy, Monday to Friday for three weeks, to the entire breast/chest wall and axillary level III and supraclavicular nodes with a daily concomitant boost of 0.5 Gy to the tumor bed, for a total daily dose of 3.2 Gy to the tumor bed (2.7 Gy + 0.5 Gy). The overall dose will be 40.5 Gy to the breast/chest wall, axillary level III and supraclavicular nodes, and 48.0 Gy to the tumor bed. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With Acute Toxicity > Grade 2 (Skin Toxicity Grade 3 or Above) Occurring Within 60 Days After First Day of Treatment | "Toxicity Grading per National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE v 3.0). Please refer to the Protocol Appendix 1 for details. Grade 1 - Mild, Grade 2 - Moderate, Grade 3 - Severe, Grade 4 - Life-threatening, Grade 5 - Death" | Posted | Count of Participants | Participants | Day 60 |
|
5 years from the first day of treatment
Adverse Events are collected throughout the study period via physical exams, lab assessments as well as patient communications.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Radiation Therapy | Intensity-modulated radiation therapy (IMRT): Patients will receive 15 daily radiation fractions of 2.7 Gy, Monday to Friday for three weeks, to the entire breast/chest wall and axillary level III and supraclavicular nodes with a daily concomitant boost of 0.5 Gy to the tumor bed, for a total daily dose of 3.2 Gy to the tumor bed (2.7 Gy + 0.5 Gy). The overall dose will be 40.5 Gy to the breast/chest wall, axillary level III and supraclavicular nodes, and 48.0 Gy to the tumor bed. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cellulitis | Infections and infestations | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal Bloating | Gastrointestinal disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Carmen A. Perez, M.D., Ph.D. | NYU Langone Health - Perlmutter Cancer Center | 212-731-5003 | Carmen.Perez@nyulangone.org |
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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 | Jun 30, 2017 | Jul 7, 2022 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D008209 | Lymphedema |
| ID | Term |
|---|---|
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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| ID | Term |
|---|---|
| D050397 | Radiotherapy, Intensity-Modulated |
| ID | Term |
|---|---|
| D020266 | Radiotherapy, Conformal |
| D011881 | Radiotherapy, Computer-Assisted |
| D011878 | Radiotherapy |
| D013812 | Therapeutics |
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|
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| Primary | Number of Participants Who Met Constraints | Treatment feasibility will be evaluated for each participant by the ability to meet all physics dose constraints: Target volume dose constraints = PTVTumor: V 48 Gy > 98%, PTVBreast: V 40.5 Gy ≥ 95%. PTVNodesEval: V 38.5 Gy > 95%. Normal tissue dose constraints = Heart: V 5 Gy < 5%, Ipsilateral lung: V 10 Gy < 20%, Contralateral lung: V 5 Gy < 15%, Spinal cord: 37.5 Gy maximum, Spinal cord plus 0.5 cm margin: 40 Gy maximum, Thyroid: contralateral lobe 15 Gy maximum, Esophagus: V 30 Gy < 50%, 40.5 Gy maximum, Ipsilateral brachial plexus: 42 Gy maximum, Contralateral breast: Efforts should be made to keep the contralateral breast completely outside the primary beams | Posted | Count of Participants | Participants | Day 60 |
|
|
|
| 4 |
| 95 |
| 1 |
| 95 |
| 87 |
| 95 |
| Abdominal Pain | Gastrointestinal disorders | Systematic Assessment |
|
| Alkaline phosphatase increased | Investigations | Systematic Assessment |
|
| Alopecia | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Altered Mental Status | Nervous system disorders | Systematic Assessment |
|
| Anemia | Blood and lymphatic system disorders | Systematic Assessment |
|
| Anorexia | Gastrointestinal disorders | Systematic Assessment |
|
| Anxiety | Psychiatric disorders | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Arthritis | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| AST elevated | Investigations | Systematic Assessment |
|
| Asthma Exacerbation | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Atrophy/Symmetry | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Autoimmune Thyroiditis | Immune system disorders | Systematic Assessment |
|
| Back Pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Bone Metastasis | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
|
| Bradycardia | Cardiac disorders | Systematic Assessment |
|
| Breast Heaviness | General disorders | Systematic Assessment |
|
| Breast Pain | General disorders | Systematic Assessment |
|
| Bruising on shin | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Grease Burn | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Burning urination | Renal and urinary disorders | Systematic Assessment |
|
| Cellulitis | Infections and infestations | Systematic Assessment |
|
| Chest Pain / Tightness | Cardiac disorders | Systematic Assessment |
|
| Chronic Kidney Disease | Renal and urinary disorders | Systematic Assessment |
|
| Chronic Myeloid Leukemia | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Creatinine Elevated | Metabolism and nutrition disorders | Systematic Assessment |
|
| Cyst, Upper Back | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
|
| Cysts, Thyroid | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
|
| DCIS, Left (Contralateral) Breast | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
|
| Decreased Libido | Reproductive system and breast disorders | Systematic Assessment |
|
| Decreased ROM | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Decreased Vision | Eye disorders | Systematic Assessment |
|
| Depression | Psychiatric disorders | Systematic Assessment |
|
| Diarrhea | Gastrointestinal disorders | Systematic Assessment |
|
| Dimpling | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Diverticulosis | Gastrointestinal disorders | Systematic Assessment |
|
| Dizziness | Nervous system disorders | Systematic Assessment |
|
| Dry Desquamation | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Dry Skin | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Dysgeusia | Gastrointestinal disorders | Systematic Assessment |
|
| Dysphagia | Gastrointestinal disorders | Systematic Assessment |
|
| Dyspnea | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Edema | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Erythema / Dermatitis | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Esophagitis | Gastrointestinal disorders | Systematic Assessment |
|
| Eye Dryness, Left | Eye disorders | Systematic Assessment |
|
| Eyelid Function Disorder | Eye disorders | Systematic Assessment |
|
| Fat Necrosis | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Fatigue | General disorders | Systematic Assessment |
|
| Fever | General disorders | Systematic Assessment |
|
| Fibrosis | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Flatulence | Gastrointestinal disorders | Systematic Assessment |
|
| Flu Like Sympotms | General disorders | Systematic Assessment |
|
| Gastric Ulcer | Gastrointestinal disorders | Systematic Assessment |
|
| Gastroesophageal Reflux | Gastrointestinal disorders | Systematic Assessment |
|
| Generalized Pain | General disorders | Systematic Assessment |
|
| Globus Sensation In Throat | Gastrointestinal disorders | Systematic Assessment |
|
| Goiter | Endocrine disorders | Systematic Assessment |
|
| Headache | Nervous system disorders | Systematic Assessment |
|
| Hematochezia | Gastrointestinal disorders | Systematic Assessment |
|
| Hemoptysis | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Hemorroids | Gastrointestinal disorders | Systematic Assessment |
|
| Hoarseness | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Hot Flashes | Endocrine disorders | Systematic Assessment |
|
| Hyperglycemia | Endocrine disorders | Systematic Assessment |
|
| Hypernatremia | Investigations | Systematic Assessment |
|
| Hyperpigmentation | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Hypertension | Cardiac disorders | Systematic Assessment |
|
| Hypothyroidism | Endocrine disorders | Systematic Assessment |
|
| Induration | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Infection | Infections and infestations | Systematic Assessment |
|
| Injury (Tore Cartilage) | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Injury-Torn Meniscus Right Knee | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Insomnia | General disorders | Systematic Assessment |
|
| Irritability | Nervous system disorders | Systematic Assessment |
|
| Keratosis | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Left Lung Post Radiation changes | General disorders | Systematic Assessment |
|
| Leg Spasms | Nervous system disorders | Systematic Assessment |
|
| Leptomeningeal Disease/ Brain Mets | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
|
| Lower Flank Pain | General disorders | Systematic Assessment |
|
| Lymphadema | Blood and lymphatic system disorders | Systematic Assessment |
|
| Mastitis | Infections and infestations | Systematic Assessment |
|
| Memory Impairment | Nervous system disorders | Systematic Assessment |
|
| Moist Desquamation | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Muscle Weakness | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Nasal Discharge | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | Systematic Assessment |
|
| Neuralgia | Nervous system disorders | Systematic Assessment |
|
| Neuropathy | Nervous system disorders | Systematic Assessment |
|
| Night Sweats | Endocrine disorders | Systematic Assessment |
|
| Nipple Discharge Left Breast | Reproductive system and breast disorders | Systematic Assessment |
|
| Nipple Inversion | Reproductive system and breast disorders | Systematic Assessment |
|
| Nipple Sensitivity | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Nipple, skin fissure | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Odynophagia | Gastrointestinal disorders | Systematic Assessment |
|
| Onychomycosis | Infections and infestations | Systematic Assessment |
|
| Osteopenia | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Osteoporosis | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Pain | General disorders | Systematic Assessment |
|
| Palpitations | Cardiac disorders | Systematic Assessment |
|
| Panic Attack-Agoraphobia | Psychiatric disorders | Systematic Assessment |
|
| Paresthesia | Nervous system disorders | Systematic Assessment |
|
| Pathological Fracture R Proximal Femur | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Pleural Effusion, Requiring Vats | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Pneumonia | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Radiation Folliculitis | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Rectal Bleeding | Gastrointestinal disorders | Systematic Assessment |
|
| Right Rib Pain On Inspiration And When Coughing | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Sensitivity To Cold, Fingers/Toes | Nervous system disorders | Systematic Assessment |
|
| Seroma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
|
| Sexual/Reproductive Disfunction | Reproductive system and breast disorders | Systematic Assessment |
|
| Shortness Of Breath | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Skin Thickening | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Sore Throat | General disorders | Systematic Assessment |
|
| Tachycardia | Cardiac disorders | Systematic Assessment |
|
| Telangiectasia | Blood and lymphatic system disorders | Systematic Assessment |
|
| Thrombocytopenia | Blood and lymphatic system disorders | Systematic Assessment |
|
| Thromboembolic Event | Blood and lymphatic system disorders | Systematic Assessment |
|
| Thrush | Infections and infestations | Systematic Assessment |
|
| TSH, Elevated | Endocrine disorders | Systematic Assessment |
|
| Tuberculosis | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Upper Respiratory Infection | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Urinary Retention | Renal and urinary disorders | Systematic Assessment |
|
| Urinary Tract Infection | Renal and urinary disorders | Systematic Assessment |
|
| Uterine Toxicity/Bleeding | Reproductive system and breast disorders | Systematic Assessment |
|
| Vaginal Atrophy/Irritation | Reproductive system and breast disorders | Systematic Assessment |
|
| Vaginal Discharge | Reproductive system and breast disorders | Systematic Assessment |
|
| Vaginal Dryness | Reproductive system and breast disorders | Systematic Assessment |
|
| Weight Gain | General disorders | Systematic Assessment |
|
| Weight Loss | General disorders | Systematic Assessment |
|
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