RCT Comparing 2 Radiotherapy HypoFractionation Schedules In Breast Cancer Patients (Breastcancer)

Randomized Clinical Trial Comparing Two Adjuvant Radiotherapy Hypo Fractionation Schedules In The Treatment of Post Mastectomy Breast Cancer Patients

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.

Study Overview

• Status: Unknown
• Conditions: Radiotherapy Side Effect; Locoregional Recurrence
• Intervention / Treatment: Radiation: Hypofractionation Schedules for Breast Cancer patients after mastecomy

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)

• Study Type: Interventional
• Enrollment (Anticipated): 166
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Momen Hassan, MSc.; Phone Number: +2001004209003; Email: momen_onco@yahoo.com
• Study Contact Backup: Name: Osama Yousof, MD; Phone Number: +20 122 775 2455; Email: osama.soliman@nci.cu.edu.eg

Study Locations

• Egypt
  • Fom Elkhalig
    • Cairo, Fom Elkhalig, Egypt, 11796
      • Recruiting
      • NCIEGYPT
      • Contact: Momen Hassan, MSc.; Phone Number: +201004209003; Email: momen_onco@yahoo.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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.
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.

Secondary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: National Cancer Institute, Egypt
• Investigators: Principal Investigator: Osama Yousof, MD, National Cancer Institute, Egypt

Publications and helpful links

Helpful Links

• 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

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2020
• Primary Completion (Anticipated): June 1, 2021
• Study Completion (Anticipated): February 1, 2022

Study Registration Dates

• First Submitted: August 18, 2020
• First Submitted That Met QC Criteria: September 15, 2020
• First Posted (Actual): September 16, 2020

Study Record Updates

• Last Update Posted (Actual): September 16, 2020
• Last Update Submitted That Met QC Criteria: September 15, 2020
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Keywords: Mastectomy; Locoregional Control; Post Op radiotherapy
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Recurrence
• Other Study ID Numbers: RO1912-30902

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No