Clinical trial NCT04550910: RCT Comparing 2 Radiotherapy HypoFractionation Schedules In Breast Cancer Patients
Official title: Randomized Clinical Trial Comparing Two Adjuvant Radiotherapy Hypo Fractionation Schedules In The Treatment of Post Mastectomy Breast Cancer Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Radiotherapy Side Effect
Locoregional Recurrence
Keywords: Post Op radiotherapy
Mastectomy
Locoregional Control
Lead sponsor: National Cancer Institute, Egypt
Sponsor class: OTHER
First posted: 2020-09-16
Enrollment: 166
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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)

Eligibility 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.

Primary outcomes:
measure: Chest wall pain
timeFrame: 3 months form starting of Adjuvant radiotherapy to chest wall.
measure: Dysphagia
timeFrame: 3 months form starting Adj radiotherapy to chest wall.
measure: Skin
timeFrame: 3 months form staring adjvant radiotherapy to chest wal.
measure: Pulmonary Toxicity
timeFrame: Assessment will be started 6 months after end of adjuvant radiotherapy to chest wall then Biannaully for 2 years.
measure: Brachial plexopathy
timeFrame: Assessment will be started 6 months after end of adjuvant radiotherapy to chest wall then Biannaully for 2 years.
measure: Lymphedema
timeFrame: Assessment will be started 6 montha form ending adjuvant radiotherapy to chest wall and axilla then then Biannaully for 2 years.
Secondary outcomes:
measure: Local control
timeFrame: Annually after the end of chest wall irradiation for 2 years. ] must be confirmed by cytological/ histological assessment
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: NCIEGYPT
state: Fom Elkhalig
Study officials:
affiliation: National Cancer Institute, Egypt
name: Osama Yousof, MD
role: PRINCIPAL_INVESTIGATOR
References: