NCT03710733

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
185

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2018

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2018

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

July 7, 2018

Completed
3 months until next milestone

First Posted

Study publicly available on registry

October 18, 2018

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2021

Completed
Last Updated

September 11, 2020

Status Verified

September 1, 2020

Enrollment Period

3.1 years

First QC Date

July 7, 2018

Last Update Submit

September 9, 2020

Conditions

Radiotherapy Side Effect

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • Patient Satisfaction: Breast Questionnaire (Breast Q)

    1 year

  • Acute Toxicity (Breast Skin)

    During treatment and up to 3 months after treatment

  • Late Toxicity (Breast Skin, Heart, Lungs)

    1 year

Study Arms (2)

Sequential boost

ACTIVE COMPARATOR

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

Concomitant boost

EXPERIMENTAL

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

Interventions

Sequential boostRADIATION

Boost (10 Gy/4 fx/1 week) is given after whole breast irradiation

Sequential boost
Concomitant boostRADIATION

Boost (8 Gy/15 fx/3 weeks) is given with whole breast irradiation

Concomitant boost

Eligibility Criteria

Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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:
  • ER/PR Known
  • Borderline results are considered positive

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Cancer Institute, Egypt

Cairo, 11796, Egypt

Location

Related Publications (5)

  • 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.

    PMID: 18356109BACKGROUND

  • 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.

    PMID: 18355913BACKGROUND

  • 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.

    PMID: 10820347BACKGROUND

  • 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.

    PMID: 20147717BACKGROUND

  • 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.

    PMID: 17379440BACKGROUND

MeSH Terms

Conditions

Radiation Injuries

Condition Hierarchy (Ancestors)

Wounds and Injuries

Study Officials

  • Medhat El Sebaie, MD

    National Cancer Institute, Egypt

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer of Radiation Oncology

Study Record Dates

First Submitted

July 7, 2018

First Posted

October 18, 2018

Study Start

June 1, 2018

Primary Completion

June 30, 2021

Study Completion

June 30, 2021

Last Updated

September 11, 2020

Record last verified: 2020-09

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)