Radiotherapy Side EffectNCT03710733
Accelerated Hypofractionated Whole Breast Irradiation Plus Sequential Boost Versus Concomitant Boost Following BCS
A study testing Sequential boost and Concomitant boost in people with Radiotherapy Side Effect, run by National Cancer Institute, Egypt at 1 site in Egypt.
Trial summary
A prospective study comparing sequential versus concomitant radiotherapy boost in breast conservative therapy. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Radiotherapy Side Effect
- What is being tested?
- Sequential boost and Concomitant boost
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 185 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jun 2018to 30 Jun 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Show all 10Show fewer
- Performance Status 0-2
- Hormone receptor status:
- ER/PR Known
- Borderline results are considered positive
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized Prospective Study of Accelerated Hypofractionated Whole Breast Irradiation Plus Sequential Boost Versus Concomitant Boost Following Breast Conservative Surgery
A prospective study comparing sequential versus concomitant radiotherapy boost in breast conservative therapy.
Read the 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).
- Conditions
- Radiotherapy Side Effect
- Being tested
- Sequential boost, Concomitant boost
- Medical subject headings
- Radiation Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sequential boostRadiation
Boost (10 Gy/4 fx/1 week) is given after whole breast irradiation
Concomitant boostRadiation
Boost (8 Gy/15 fx/3 weeks) is given with whole breast irradiation
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Radiation: Concomitant boost |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 1 year
Secondary outcomes (3)
Patient Satisfaction: Breast Questionnaire (Breast Q)
Using Breast Questionnaire (Breast Q)
Measured: 1 year
Acute Toxicity (Breast Skin)
Using Radiation Therapy Oncology Group (RTOG) Acute Radiation Morbidity Scoring Criteria
Measured: During treatment and up to 3 months after treatment
Late Toxicity (Breast Skin, Heart, Lungs)
Using Radiation Therapy Oncology Group (RTOG) Late Radiation Morbidity Scoring Criteria
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2018
- Study start1 Jun 2018
- Primary completion30 Jun 2021 (estimated)
- Study completion30 Jun 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Radiotherapy Side EffectStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 185 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute, Egypt
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rimoun Ramsis Anis Boutrus, National Cancer Institute, Egypt
- Investigators
- Medhat El Sebaie, MD, Study director, National Cancer Institute, Egypt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03710733
- Sponsor's protocol ID
- 201617079.3
- Status last verified
- Sep 2020
- First submitted
- 7 Jul 2018
- Last updated
- 11 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 18356109START 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.
PubMed 18355913Whelan 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.
PubMed 10820347Whelan 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.
PubMed 20147717van 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.
PubMed 17379440
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Prospective Study of Accelerated Hypofractionated Whole Breast Irradiation Plus Sequential Boost Versus Concomitant Boost Following Breast Conservative Surgery
- ClinicalTrials.gov ID
- NCT03710733
- Acronym / sponsor ID
- 201617079.3
- Conditions
- Radiotherapy Side Effect
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 185 participants (estimated)
- Lead sponsor
- National Cancer Institute, EgyptUniversity, hospital or other
- Study start
- 1 Jun 2018 (actual)
- Primary completion
- 30 Jun 2021 (estimated)
- Study completion
- 30 Jun 2021 (estimated)
- First posted
- 18 Oct 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sequential boost | Active comparator | Radiation: Sequential boostHypofractionated 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 |
| Concomitant boost | Experimental | Radiation: Concomitant boostHypofractionated 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 |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sequential boostBoost (10 Gy/4 fx/1 week) is given after whole breast irradiation | Radiation | Sequential boost |
| Concomitant boostBoost (8 Gy/15 fx/3 weeks) is given with whole breast irradiation | Radiation | Concomitant boost |
Primary outcome
Change in Breast Cosmetic Outcome
Time frame: 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
3 secondary outcomes
Patient Satisfaction: Breast Questionnaire (Breast Q)
Time frame: 1 year
Acute Toxicity (Breast Skin)
Time frame: During treatment and up to 3 months after treatment
Late Toxicity (Breast Skin, Heart, Lungs)
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2020.
- Background: PubMed 18356109START 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.
- Background: PubMed 18355913START 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.
- Background: PubMed 10820347Whelan 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.
- Background: PubMed 20147717Whelan 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.
- Background: PubMed 17379440van 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Medhat El Sebaie, MD study director
National Cancer Institute, Egypt
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sequential boost and Concomitant boost in people with Radiotherapy Side Effect, run by National Cancer Institute, Egypt at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Breast Cosmetic Outcome (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03710733, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Sep 2020.