Locoregional Recurrence, Radiotherapy Side Effect
Conditions
Keywords
Post Op radiotherapy, Mastectomy, Locoregional Control
Brief summary
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.
Detailed description
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 : 1. Acute and late toxicity regarding pain, pulmonary toxicity, dysphagia, skin toxicity and lymphedema.Assessment will be done according to RTOG and CTCv.5. 2. Any local (chest wall) recurrence, regional (nodal) recurrence. B)Annual Mammogram. C)Any another investigation (once indicated)
Interventions
RADIATIONHypofractionation Schedules for Breast Cancer patients after mastecomy
Two Radiotherapy HypoFractionation Schedules will be applied, after randomization, for female breast cancer patients after mastectomy.
Sponsors
National Cancer Institute, Egypt
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
DOUBLE (Caregiver, Investigator)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Invasive carcinoma of the breast. * Complete microscopic excision of primary tumour and axillary dissection or SLNB . * Females with locally advanced breast cancer ( T3/T4 or N + or both ) who are candidate for neoadjvant chemotherapy regardless pathological stage after mastectomy. * Patients with pathological stage (T3/ T4, +/- N+) or ( N+, any T) after upfront mastectomy. * Able to comply with follow up. * Written informed consent
Exclusion criteria
* Patients do not match with inclusion criteria. * Collagen vascular disease, specifically systemic lupus, or scleroderma. * Pregnancy or lactation at the time of radiotherapy.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Skin | 3 months form staring adjvant radiotherapy to chest wal. | 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. |
| Chest wall pain | 3 months form starting of Adjuvant radiotherapy to chest wall. | 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. |
| Dysphagia | 3 months form starting Adj radiotherapy to chest wall. | 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. |
| Lymphedema | Assessment will be started 6 montha form ending adjuvant radiotherapy to chest wall and axilla then then Biannaully for 2 years. | 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) |
| Pulmonary Toxicity | Assessment will be started 6 months after end of adjuvant radiotherapy to chest wall then Biannaully for 2 years. | 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. |
| Brachial plexopathy | Assessment will be started 6 months after end of adjuvant radiotherapy to chest wall then Biannaully for 2 years. | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Local control | Annually after the end of chest wall irradiation for 2 years. ] must be confirmed by cytological/ histological assessment | Local Recurrence Rate (LCR) including ipsilateral chest wall +/- regional nodal recurrence |
Countries
Egypt
Contacts
Primary ContactMomen Hassan, MSc.
Backup ContactOsama Yousof, MD
Outcome results
None listed