Breastcancer: RCT Comparing 2 Radiotherapy HypoFractionation Schedules In Breast Cancer Patients
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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 :
-
Acute and late toxicity regarding pain, pulmonary toxicity, dysphagia, skin toxicity and lymphedema.Assessment will be done according to RTOG and CTCv.5.
-
Any local (chest wall) recurrence, regional (nodal) recurrence.
B)Annual Mammogram. C)Any another investigation (once indicated)
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Other: Arm A 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 |
Radiation: Hypofractionation Schedules for Breast Cancer patients after mastecomy
Two Radiotherapy HypoFractionation Schedules will be applied, after randomization, for female breast cancer patients after mastectomy.
|
| Experimental: Arm B 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 |
Radiation: Hypofractionation Schedules for Breast Cancer patients after mastecomy
Two Radiotherapy HypoFractionation Schedules will be applied, after randomization, for female breast cancer patients after mastectomy.
|
Outcome Measures
Primary Outcome Measures
- 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.
- 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.
- 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.
- 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)
Secondary Outcome Measures
- 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
Eligibility Criteria
Criteria
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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | NCIEGYPT | Cairo | Fom Elkhalig | Egypt | 11796 |
Sponsors and Collaborators
- National Cancer Institute, Egypt
Investigators
- Principal Investigator: Osama Yousof, MD, National Cancer Institute, Egypt
Study Documents (Full-Text)
None provided.More Information
Additional Information:
- First results of the randomised UK FAST Trial of radiotherapy hypofractionation for treatment of early breast cancer (CRUKE/04/015): The FAST Trial lists group. Radiotherapy and Oncology, 100(1), pp.93
- FAST Trial Finds Long-Term Side Effects Similar for Once-Weekly and Conventional Breast Radiation Therapies
Publications
None provided.- RO1912-30902