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This is a prospective randomized Phase III trial to assess efficiency of two post mastectomy hypofractionation schedules (40 Gy /15 fx / 3 weeks, 5 days per week VS 28.5 Gy delivered in 5 once-weekly fractions of 5.7 Gy each week) as adjuvant radiotherapy in female patients with breast cancer after mastectomy.
166 patients of breast cancer patients after mastectomy ( 83 patients in each arm ) will be randomize into 2 hypofractionation arms : Arm A: 40 Gy /15 fx / 3 weeks, 5 days per week . Arm B: 28.5 Gy delivered in 5 once-weekly fractions of 5.7 Gy each week.
Simulation:
Patient will be simulated on CT simulator using breast wedge with angle. Serials will be taken every 2 mm from upper neck down to mid abdomen.
Contouring:
CTVcw, CTVRNI will be contoured through RTOG guidelines . PTV is added as 0.5 cm all around CTV. Lungs, Heart, brachial plexus, spinal cord, esophageus and thyroid will be contoured as OAR. (www.rtog.org/CoreLab/ContouringAtlases/BreastCancerAtlas.aspx).
D)Dose Constraints:
Arm A:
PTV EVAL ( CW) : V90 % ≥ 90 %. - V105 % ≤ 5% - V107%≤ 3 %. Ipsilateral lung: V20 less than 20-25% - V 8 less than 35%- Contra lateral lung: V4 less 10 %. Heart: V16 less than 5% (Lt sided). V20 less than 5% (Lt sided). V16 is 0%.(Rt sided) V20 is 0% (Rt sided). Mean heart dose ≤ 320-400 cGy. Contra lateral breast : D max≤ 240 cGy. V 144 cGy less than 5 %. SCV : V90 % ≥ 90 %. Thyroid : Mean dose less than 35 Gy - V30 less than 50 %.
Arm B:
PTV EVAL ( CW) : V90 %≥ 90 %. - V105 %≤ 5% - V107%≤ 2 %.
Ipsilateral lung: V30%less than 15 -20% - V15% less than 30-35% - V5 % less than 50-55%.
Contra lateral lung : V5 % less than 5%. Heart :V25 % less than 5 % - V5 % less than 30 - 35 %. Contra lateral breast: V3 % less than 5 %. SCV : V90 % ≥ 90 %.
Follow up:
A)Weekly follow up will be done during sessions then regular clinical exam every 3 months to assess :
B)Annual Mammogram. C)Any another investigation (once indicated)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm A | Other | 40 Gy /15 fx / 3 weeks, 5 days per week, is a dose prescribed (after randomization ) for Breast Cancer patients indicated for adjuvant RTH after mastectomy |
|
| Arm B | Experimental | 28.5 Gy delivered in 5 once-weekly fractions of 5.7 Gy is a dose prescribed (after randomization )for Breast Cancer patients indicated for adjuvant RTH after mastectomy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hypofractionation Schedules for Breast Cancer patients after mastecomy | Radiation | Two Radiotherapy HypoFractionation Schedules will be applied, after randomization, for female breast cancer patients after mastectomy. |
| Measure | Description | Time Frame |
|---|---|---|
| Chest wall pain | Grades of toxicity will be assessed according to The Radiation Therapy Oncology Group (RTOG) morbidity scoring criteria. Scoring starts with low grade toxicity sacle ( Grade 1 or 2) while Grade 3 or 4 considered High grade toxicity. | 3 months form starting of Adjuvant radiotherapy to chest wall. |
| Dysphagia | Grades of toxicity will be assessed according to The Radiation Therapy Oncology Group (RTOG) morbidity scoring criteria. Scoring starts with low grade toxicity sacle ( Grade 1 or 2) while Grade 3 or 4 considered High grade toxicity. | 3 months form starting Adj radiotherapy to chest wall. |
| Skin | Grades of toxicity will be assessed according to The Radiation Therapy Oncology Group (RTOG) morbidity scoring criteria. Scoring starts with low grade toxicity sacle ( Grade 1 or 2) while Grade 3 or 4 considered High grade toxicity. | 3 months form staring adjvant radiotherapy to chest wal. |
| Pulmonary Toxicity | Grades of toxicity will be assessed according to The Radiation Therapy Oncology Group (RTOG) morbidity scoring criteria. Scoring starts with low grade toxicity sacle ( Grade 1 or 2) while Grade 3 or 4 considered High grade toxicity. | Assessment will be started 6 months after end of adjuvant radiotherapy to chest wall then Biannaully for 2 years. |
| Brachial plexopathy | Grades of toxicity will be assessed according to The Radiation Therapy Oncology Group (RTOG) morbidity scoring criteria. Scoring starts with low grade toxicity sacle ( Grade 1 or 2) while Grade 3 or 4 considered High grade toxicity. | Assessment will be started 6 months after end of adjuvant radiotherapy to chest wall then Biannaully for 2 years. |
| Measure | Description | Time Frame |
|---|---|---|
| Local control | Local Recurrence Rate (LCR) including ipsilateral chest wall +/- regional nodal recurrence | Annually after the end of chest wall irradiation for 2 years. ] must be confirmed by cytological/ histological assessment |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Momen Hassan, MSc. | Contact | +2001004209003 | momen_onco@yahoo.com | |
| Osama Yousof, MD | Contact | +20 122 775 2455 | osama.soliman@nci.cu.edu.eg |
| Name | Affiliation | Role |
|---|---|---|
| Osama Yousof, MD | National Cancer Institute, Egypt | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| NCIEGYPT | Recruiting | Cairo | Fom Elkhalig | 11796 | Egypt |
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| Label | URL |
|---|---|
| FAST Trial Finds Long-Term Side Effects Similar for Once-Weekly and Conventional Breast Radiation Therapies | View source |
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| ID | Term |
|---|---|
| D011832 | Radiation Injuries |
| ID | Term |
|---|---|
| D014947 | Wounds and Injuries |
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| Lymphedema | Common Toxicity Criteria v.5 ( Arm volume at CC.Grading done according to Interlimb Volume Difference.Interlimb volume difference > 30 % is considered Grade 3 Lymphedema) and Cheng scale ( To detect proportion of patients having moderate or severe lymphedema (Grade 》II) | Assessment will be started 6 montha form ending adjuvant radiotherapy to chest wall and axilla then then Biannaully for 2 years. |