RCT Comparing 2 Radiotherapy HypoFractionation Schedules In Breast Cancer Patients

NCT04550910 | Unknown DMC

• 1 other identifier: RO1912-30902
• Study Type: interventional
• Target: 166
• Locations: 1 country
• Sites: 1

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.

Conditions

Radiotherapy Side Effect; Locoregional Recurrence

Keywords

Post Op radiotherapy; Mastectomy; Locoregional Control

Outcome Measures

Primary Outcomes (6)

• 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 Outcomes (1)

• Local control

  Annually after the end of chest wall irradiation for 2 years. ] must be confirmed by cytological/ histological assessment

Study Arms (2)

Arm A

OTHER

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

Arm B

EXPERIMENTAL

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

Interventions

Hypofractionation Schedules for Breast Cancer patients after mastecomy RADIATION

Two Radiotherapy HypoFractionation Schedules will be applied, after randomization, for female breast cancer patients after mastectomy.

Arm A; Arm B

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Collagen vascular disease, specifically systemic lupus, or scleroderma.
• Pregnancy or lactation at the time of radiotherapy.

Sponsors & Collaborators

• National Cancer Institute, Egypt: lead

Study Sites (1)

NCIEGYPT

Cairo, Fom Elkhalig, 11796, Egypt

RECRUITING

Related 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

MeSH Terms

Conditions

Radiation Injuries

Condition Hierarchy (Ancestors)

Wounds and Injuries

Study Officials

• Osama Yousof, MD

  National Cancer Institute, Egypt

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Momen Hassan, MSc.

CONTACT

+2001004209003; momen_onco@yahoo.com

Osama Yousof, MD

CONTACT

+20 122 775 2455; osama.soliman@nci.cu.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, INVESTIGATOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Lecturer of Radiation Oncology

Study Record Dates

• First Submitted: August 18, 2020
• First Posted: September 16, 2020
• Study Start: January 1, 2020
• Primary Completion: June 1, 2021
• Study Completion: February 1, 2022
• Last Updated: September 16, 2020

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)