RCT Comparing 2 Radiotherapy HypoFractionation Schedules In Breast Cancer Patients
NCT ID: NCT04550910
Last Updated: 2020-09-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
166 participants
INTERVENTIONAL
2020-01-01
2022-02-01
Brief Summary
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Detailed Description
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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)
Conditions
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Study Design
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RANDOMIZED
PARALLEL
OTHER
DOUBLE
Study Groups
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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
Hypofractionation Schedules for Breast Cancer patients after mastecomy
Two Radiotherapy HypoFractionation Schedules will be applied, after randomization, for female breast cancer patients after mastectomy.
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
Hypofractionation Schedules for Breast Cancer patients after mastecomy
Two Radiotherapy HypoFractionation Schedules will be applied, after randomization, for female breast cancer patients after mastectomy.
Interventions
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Hypofractionation Schedules for Breast Cancer patients after mastecomy
Two Radiotherapy HypoFractionation Schedules will be applied, after randomization, for female breast cancer patients after mastectomy.
Eligibility Criteria
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Inclusion Criteria
* 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
* Collagen vascular disease, specifically systemic lupus, or scleroderma.
* Pregnancy or lactation at the time of radiotherapy.
18 Years
75 Years
FEMALE
No
Sponsors
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National Cancer Institute, Egypt
OTHER
Responsible Party
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Momen Elsayed Hassan, MSc.
Assistant Lecturer of Radiation Oncology
Principal Investigators
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Osama Yousof, MD
Role: PRINCIPAL_INVESTIGATOR
National Cancer Institute, Egypt
Locations
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NCIEGYPT
Cairo, Fom Elkhalig, Egypt
Countries
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Central Contacts
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Facility Contacts
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Related Links
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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
Other Identifiers
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RO1912-30902
Identifier Type: -
Identifier Source: org_study_id
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