Clinical trial NCT03710733: Accelerated Hypofractionated Whole Breast Irradiation Plus Sequential Boost Versus Concomitant Boost Following BCS
Official title: Randomized Prospective Study of Accelerated Hypofractionated Whole Breast Irradiation Plus Sequential Boost Versus Concomitant Boost Following Breast Conservative Surgery
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Radiotherapy Side Effect
Lead sponsor: National Cancer Institute, Egypt
Sponsor class: OTHER
First posted: 2018-10-18
Enrollment: 185
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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).

Eligibility criteria: 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

Primary outcomes:
measure: Change in Breast Cosmetic Outcome
timeFrame: 1 year
Secondary outcomes:
measure: Patient Satisfaction: Breast Questionnaire (Breast Q)
timeFrame: 1 year
measure: Acute Toxicity (Breast Skin)
timeFrame: During treatment and up to 3 months after treatment
measure: Late Toxicity (Breast Skin, Heart, Lungs)
timeFrame: 1 year
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: National Cancer Institute, Egypt
Study officials:
affiliation: National Cancer Institute, Egypt
name: Medhat El Sebaie, MD
role: STUDY_DIRECTOR
References:
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.
citation: 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.
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.
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.
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. doi: 10.1016/j.ijrobp.2007.01.037. Epub 2007 Mar 26.