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

Radiotherapy Side Effect Clinical Trial

Official title:

Randomized Prospective Study of Accelerated Hypofractionated Whole Breast Irradiation Plus Sequential Boost Versus Concomitant Boost Following Breast Conservative Surgery

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03710733
• Other study ID #: 201617079.3
• Status: Active, not recruiting
• Phase: N/A
• Start date: June 1, 2018
• Est. completion date: June 30, 2021

Study information

• Verified date: September 2020
• Source: National Cancer Institute, Egypt
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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).

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 185
• Est. completion date: June 30, 2021
• Est. primary completion date: June 30, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Radiotherapy Side Effect

Intervention

Radiation:
• Sequential boost
Boost (10 Gy/4 fx/1 week) is given after whole breast irradiation
• Concomitant boost
Boost (8 Gy/15 fx/3 weeks) is given with whole breast irradiation

Locations

Country	Name	City	State
Egypt	National Cancer Institute, Egypt	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
National Cancer Institute, Egypt

Country where clinical trial is conducted

Egypt, 

References & Publications (5)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Breast Cosmetic Outcome	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	1 year
Secondary	Patient Satisfaction: Breast Questionnaire (Breast Q)	Using Breast Questionnaire (Breast Q)	1 year
Secondary	Acute Toxicity (Breast Skin)	Using Radiation Therapy Oncology Group (RTOG) Acute Radiation Morbidity Scoring Criteria	During treatment and up to 3 months after treatment
Secondary	Late Toxicity (Breast Skin, Heart, Lungs)	Using Radiation Therapy Oncology Group (RTOG) Late Radiation Morbidity Scoring Criteria	1 year