Accelerated Hypofractionated Whole Breast Irradiation Plus Sequential Boost Versus Concomitant Boost Following BCS

• Sponsor: National Cancer Institute, Egypt (Other)
• Overall Status: Active, not recruiting
• CT.gov ID: NCT03710733
• Collaborator: (none)
• Enrollment: 185
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 37
• Patients Per Site Per Month: 5

Study Details

Study Description

Brief Summary

A prospective study comparing sequential versus concomitant radiotherapy boost in breast conservative therapy.

Condition or Disease	Intervention/Treatment	Phase
Radiotherapy Side Effect	Radiation: Sequential boost; Radiation: Concomitant boost	N/A

Detailed Description

This study is a prospective randomized non-inferiority trial of accelerated hypofractionated whole breast irradiation plus sequential boost versus concomitant boost after breast conservative surgery. It will be conducted on 124 patients who will be randomized using permuted blocks. The primary outcome measured is the cosmetic outcome, while secondary outcomes are patient satisfaction (using breast questionnaire), acute toxicity (using RTOG acute toxicity scoring criteria), and late toxicity (using RTOG late toxicity scoring criteria).

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 185 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• Primary Purpose: Treatment
• Official Title: Randomized Prospective Study of Accelerated Hypofractionated Whole Breast Irradiation Plus Sequential Boost Versus Concomitant Boost Following Breast Conservative Surgery
• Actual Study Start Date: Jun 1, 2018
• Anticipated Primary Completion Date: Jun 30, 2021
• Anticipated Study Completion Date: Jun 30, 2021

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Sequential boost Hypofractionated whole breast irradiation 40 Gy/15 fx (2.67 Gy/fx) plus sequential boost 10 Gy/4 fx (2.5 Gy/fx) to lumpectomy cavity	Radiation: Sequential boost; Boost (10 Gy/4 fx/1 week) is given after whole breast irradiation
Experimental: Concomitant boost Hypofractionated whole breast irradiation 40 Gy/15 fx (2.67 Gy/fx) plus concomitant boost 8 Gy/15 fx (0.53 Gy/fx) to lumpectomy cavity	Radiation: Concomitant boost; Boost (8 Gy/15 fx/3 weeks) is given with whole breast irradiation

Outcome Measures

Primary Outcome Measures

1. Change in Breast Cosmetic Outcome [1 year]

   Rate the qualities of the treated breast as compared with the untreated breast using European Organization for Research and Treatment of Cancer (EORTC) Cosmetic Rating System

Secondary Outcome Measures

1. Patient Satisfaction: Breast Questionnaire (Breast Q) [1 year]

   Using Breast Questionnaire (Breast Q)

2. Acute Toxicity (Breast Skin) [During treatment and up to 3 months after treatment]

   Using Radiation Therapy Oncology Group (RTOG) Acute Radiation Morbidity Scoring Criteria

3. Late Toxicity (Breast Skin, Heart, Lungs) [1 year]

   Using Radiation Therapy Oncology Group (RTOG) Late Radiation Morbidity Scoring Criteria

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Histopathologically proven breast cancer resected by lumpectomy

• Female patient

• Invasive breast cancer

• Negative surgical margin

• Age < or equal 50 years, or high-grade irrespective of age

• Appropriate stage for protocol entry i.e. no metastasis

• Performance Status 0-2

• Hormone receptor status:

1. ER/PR Known

2. Borderline results are considered positive

Exclusion Criteria:

• Metastatic patients

• Paget's disease of nipple

• Non-epithelial breast malignancy e.g. sarcoma, lymphoma

• Unresected suspicious microcalcifications in the same or contralateral breast

• Pregnant women

• Inability to delineate lumpectomy cavity

• Psychiatric or addictive disorders rendering treatment or follow-up difficult

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	National Cancer Institute, Egypt	Cairo		Egypt	11796

Sponsors and Collaborators

• National Cancer Institute, Egypt

Investigators

• Study Director: Medhat El Sebaie, MD, National Cancer Institute, Egypt

Study Documents (Full-Text)

None provided.

More Information

Publications

• START Trialists' Group, Bentzen SM, Agrawal RK, Aird EG, Barrett JM, Barrett-Lee PJ, Bentzen SM, Bliss JM, Brown J, Dewar JA, Dobbs HJ, Haviland JS, Hoskin PJ, Hopwood P, Lawton PA, Magee BJ, Mills J, Morgan DA, Owen JR, Simmons S, Sumo G, Sydenham MA, Venables K, Yarnold JR. The UK Standardisation of Breast Radiotherapy (START) Trial B of radiotherapy hypofractionation for treatment of early breast cancer: a randomised trial. Lancet. 2008 Mar 29;371(9618):1098-107. doi: 10.1016/S0140-6736(08)60348-7. Epub 2008 Mar 19.
• START Trialists' Group, Bentzen SM, Agrawal RK, Aird EG, Barrett JM, Barrett-Lee PJ, Bliss JM, Brown J, Dewar JA, Dobbs HJ, Haviland JS, Hoskin PJ, Hopwood P, Lawton PA, Magee BJ, Mills J, Morgan DA, Owen JR, Simmons S, Sumo G, Sydenham MA, Venables K, Yarnold JR. The UK Standardisation of Breast Radiotherapy (START) Trial A of radiotherapy hypofractionation for treatment of early breast cancer: a randomised trial. Lancet Oncol. 2008 Apr;9(4):331-41. doi: 10.1016/S1470-2045(08)70077-9. Epub 2008 Mar 19.
• van der Laan HP, Dolsma WV, Maduro JH, Korevaar EW, Hollander M, Langendijk JA. Three-dimensional conformal simultaneously integrated boost technique for breast-conserving radiotherapy. Int J Radiat Oncol Biol Phys. 2007 Jul 15;68(4):1018-23. Epub 2007 Mar 26.
• Whelan TJ, Levine M, Julian J, Kirkbride P, Skingley P. The effects of radiation therapy on quality of life of women with breast carcinoma: results of a randomized trial. Ontario Clinical Oncology Group. Cancer. 2000 May 15;88(10):2260-6.
• Whelan TJ, Pignol JP, Levine MN, Julian JA, MacKenzie R, Parpia S, Shelley W, Grimard L, Bowen J, Lukka H, Perera F, Fyles A, Schneider K, Gulavita S, Freeman C. Long-term results of hypofractionated radiation therapy for breast cancer. N Engl J Med. 2010 Feb 11;362(6):513-20. doi: 10.1056/NEJMoa0906260.

• Responsible Party: Rimoun Ramsis Anis Boutrus, Lecturer of Radiation Oncology, National Cancer Institute, Egypt
• ClinicalTrials.gov Identifier: NCT03710733
• Other Study ID Numbers: 201617079.3
• First Posted: Oct 18, 2018
• Last Update Posted: Sep 11, 2020
• Last Verified: Sep 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Study Results

No Results Posted as of Sep 11, 2020