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Breast CancerNCT02858934

Feasibility Study of Accelerated Preoperative Radiotherapy for Early Breast Cancer

A study testing Tomotherapy in people with Breast Cancer, run by Andre Nazac at 3 sites in Belgium.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The standard treatment for women with a relatively small breast cancer without arguments for involvement of the axillary lymph nodes, is breast conserving surgery followed by radiotherapy of the whole breast, often with a complementary dose to the operated area (boost). Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Breast Cancer
What is being tested?
Tomotherapy
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
24 participants
Where
3 sitesBelgium
Study dates
8 Mar 2017to 3 Mar 2022
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 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age ≥ 18 years
  • Histological diagnosis of unifocal invasive breast carcinoma, no special type (ductal carcinoma)
  • Tumor Staging: cT1-2N0M0
  • Luminal A or B
  • Candidate for breast conserving surgery
  • N0-status confirmed by lymph node cytology

Who cannot join

  • Multifocal/multicentric disease
  • Prior thoracic radiotherapy
  • Pregnancy
  • SBR3 grading
  • Triple negative status which benefit neoadjuvant chemotherapy

Trial locations and contacts

3 sites in 1 country.

Belgium3 sites

  • CHU Brugmann

    Brussels, 1020

  • UZ Brussel

    Brussels, 1090

  • AZ Sint Blasius

    Dendermonde, 9200

Other trials in Belgium

About this study

The standard treatment for women with a relatively small breast cancer without arguments for involvement of the axillary lymph nodes, is breast conserving surgery followed by radiotherapy of the whole breast, often with a complementary dose to the operated area (boost). A delay of 3-4 weeks after surgery is advisable for allowing wound healing before the start of radiotherapy. Historically, whole breast radiotherapy plus boost are delivered in 6-7 weeks. This treatment can be associated with temporary fatigue and decrease in quality of life. Randomized trials have shown that shorter schedules, delivering slightly more dose per day during 3 weeks, are equal to the long schedules. In an earlier clinical study, the investigators have tested such a short schedule and shown that it is equally safe and equally well tolerated as the conventional schemes. Other hospitals have examined (and still are examining) the safety and tolerance of even shorter schedules, delivering radiotherapy in 1 week.

This clinical study involves delivering radiotherapy in 1 week and before the surgery in stead of following surgery. In the postoperative setting, it is often debatable which volume should be included in the boost. Often boost-volumes remain large because of uncertainties in delineation. Preoperative radiotherapy has the advantage that the tumor is visible on imaging. This can result in smaller boost volumes. The surgery will follow shortly after termination of the radiotherapy, resulting in a very short treatment period.

This study is an open study investigating the effect on quality of life of a very short preoperative radiotherapy for early breast cancer.

Read the detailed description

Women with early breast cancer are treated with breast conserving surgery (BCS) followed by whole breast irradiation (WBI) and a complementary dose to the lumpectomy cavity (boost). A delay of 3-4 weeks after surgery is advisable for allowing wound healing before the start of radiotherapy. Historically, WBI plus boost are delivered in 6-7 weeks. This treatment is associated with fatigue and a decreased quality of life. Randomized trials have shown that shorter hypofractionated schedules, delivering radiotherapy in 3 weeks, are equal to the long schedules. The investigators have shown that a hypofractionated tomotherapy with a simultaneous integrated boost is oncologically safe, well tolerated and has less impact on quality of life than the conventional schemes.

In the postoperative setting, it is often debatable which volume should be included in the boost. Surgical clips can help to decrease inter-observer variability, but often boost-volumes remain large because of uncertainties in delineation. Preoperative radiotherapy has the advantage that the gross tumor volume (GTV) is visible on imaging. This can result in smaller boost volumes.

The aim of this study is to investigate the feasibility of a short preoperative tomotherapy. The potential benefits are

  • a decrease in overall treatment time
  • a positive effect on quality of life
  • a more precise target delineation
  • profitable health economics.
Conditions
Breast Cancer
Being tested
Tomotherapy
Keywords
Short preoperative tomotherapy, Radiotherapy
Medical subject headings
Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TomotherapyRadiation

    Dose prescription:

    Whole breast irradiation: 25 Gy in 5 daily fractions of 5 Gy Boost: 30 Gy in 5 daily fractions of 6 Gy The boost will be delivered as a simultaneous integrated boost (SIB).

    Target volumes:

    Clinical target volume (CTV) breast: defined by the soft tissue of the breast down to the pectoralis fascia, but excluding the skin and the underlying muscle, ribs, lung and heart.

    Gross tumor volume (GTV) boost: includes all gross tumor volume, as visible on computer tomography, mammography and/or magnetic resonance imaging (MRI). MRI imaging is preferentially performed in treatment position.

    CTV boost: includes the primary tumor, with a margin of 1.0 cm in all directions to encompass potential microscopic disease extension. The CTV boost excludes the skin, pectoralis muscle, ribs, lung and heart.

    Planning target volume (PTV): CTV plus a margin of 5 mm in all directions, but limited at 5 mm below the skin surface.

Study groups in NCT02858934
Study groupRoleWhat they receive
preoperative tomotherapyExperimentalThis study is an open study investigating the effect on quality of life of a very short preoperative radiotherapy for early breast cancer, including approximately 24 women. Radiotherapy will be performed in 1 week and before the surgery in stead of following surgery.Preoperative radiotherapy has the advantage that the tumor is visible on imaging. This can result in smaller boost volumes. The surgery will follow shortly after termination of the radiotherapy, resulting in a very short treatment period.
Receives: Radiation: Tomotherapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Duration of the surgical procedure

    Duration of the breast conserving surgery (lumpectomy + sentinel lymph node procedure)

    Measured: from 2 to 8 days after the last radiotherapy session.

  2. Quantity of blood lost

    Quantity of blood that has been lost during the breast conservation surgery, performed 2 to 8 days after the last radiotherapy session.

    Measured: from 2 to 8 days after the last radiotherapy session.

  3. Dindo score

    Post operative morbidity assessment according to Dindo, Demartines et al.

    Measured: Week 6 after radiotherapy start

  4. Wound disruption (yes/no)

    Presence of wound disruption defined as skin dehiscence from any cause including seroma or hematoma.

    Measured: up to 30 days post operative

  5. Wound infection (yes/no)

    Presence of wound infection, defined as: purulent drainage, cellulitis, abscess or wound requiring drainage, debriding, and antibiotics associated with a clinical diagnosis of infection.

    Measured: up to 30 days post operative

  6. Number of adverse events

    Acute radiation toxicity measure

    Measured: up to three months after radiotherapy start

Secondary outcomes (6)

  1. QLQ-C30 questionnaire

    Assessment of the quality of life, according to the QLQC30 questionnaire

    Measured: week 3 after radiotherapy start

  2. QLQ-C30 questionnaire

    Assessment of the quality of life, according to the QLQC30 questionnaire

    Measured: week 6 after radiotherapy start

  3. EORTC QLQ-BR23 questionnaire

    Assessment of the quality of life, according to the EORTC BR23 questionnaire

    Measured: week 3 after radiotherapy start

  4. EORTC QLQ-BR23 questionnaire

    Assessment of the quality of life, according to the EORTC BR23 questionnaire

    Measured: week 6 after radiotherapy start

  5. Number of adverse events

    Late toxicity measure

    Measured: from three months after radiotherapy start till end of study (up to 1 years)

  6. Local recurrence (yes/no)

    Local control: presence of local cancer recurrence

    Measured: up till the end of study (1 year)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Aug 2016 (estimated)
  2. Study start8 Mar 2017
  3. Primary completion3 Mar 2022
  4. Study completion3 Mar 2022

Resources

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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
24 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02858934
Sponsor's protocol ID
CHUB-Preop-Breast
Status last verified
Jul 2022
First submitted
4 Aug 2016
Last updated
20 Jul 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Senkus E, Kyriakides S, Ohno S, Penault-Llorca F, Poortmans P, Rutgers E, Zackrisson S, Cardoso F; ESMO Guidelines Committee. Primary breast cancer: ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up. Ann Oncol. 2015 Sep;26 Suppl 5:v8-30. doi: 10.1093/annonc/mdv298. No abstract available.

    PubMed 26314782

  • Bartelink H, Horiot JC, Poortmans PM, Struikmans H, Van den Bogaert W, Fourquet A, Jager JJ, Hoogenraad WJ, Oei SB, Warlam-Rodenhuis CC, Pierart M, Collette L. Impact of a higher radiation dose on local control and survival in breast-conserving therapy of early breast cancer: 10-year results of the randomized boost versus no boost EORTC 22881-10882 trial. J Clin Oncol. 2007 Aug 1;25(22):3259-65. doi: 10.1200/JCO.2007.11.4991. Epub 2007 Jun 18.

    PubMed 17577015

  • 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.

    PubMed 20147717

  • Haviland JS, Owen JR, Dewar JA, Agrawal RK, Barrett J, Barrett-Lee PJ, Dobbs HJ, Hopwood P, Lawton PA, Magee BJ, Mills J, Simmons S, Sydenham MA, Venables K, Bliss JM, Yarnold JR; START Trialists' Group. The UK Standardisation of Breast Radiotherapy (START) trials of radiotherapy hypofractionation for treatment of early breast cancer: 10-year follow-up results of two randomised controlled trials. Lancet Oncol. 2013 Oct;14(11):1086-1094. doi: 10.1016/S1470-2045(13)70386-3. Epub 2013 Sep 19.

    PubMed 24055415

  • Van Parijs H, Miedema G, Vinh-Hung V, Verbanck S, Adriaenssens N, Kerkhove D, Reynders T, Schuermans D, Leysen K, Hanon S, Van Camp G, Vincken W, Storme G, Verellen D, De Ridder M. Short course radiotherapy with simultaneous integrated boost for stage I-II breast cancer, early toxicities of a randomized clinical trial. Radiat Oncol. 2012 Jun 1;7:80. doi: 10.1186/1748-717X-7-80.

    PubMed 22656865

  • Versmessen H, Vinh-Hung V, Van Parijs H, Miedema G, Voordeckers M, Adriaenssens N, Storme G, De Ridder M. Health-related quality of life in survivors of stage I-II breast cancer: randomized trial of post-operative conventional radiotherapy and hypofractionated tomotherapy. BMC Cancer. 2012 Oct 25;12:495. doi: 10.1186/1471-2407-12-495.

    PubMed 23098579

  • van Mourik AM, Elkhuizen PH, Minkema D, Duppen JC; Dutch Young Boost Study Group; van Vliet-Vroegindeweij C. Multiinstitutional study on target volume delineation variation in breast radiotherapy in the presence of guidelines. Radiother Oncol. 2010 Mar;94(3):286-91. doi: 10.1016/j.radonc.2010.01.009. Epub 2010 Mar 2.

    PubMed 20199818

  • Kirby AN, Jena R, Harris EJ, Evans PM, Crowley C, Gregory DL, Coles CE. Tumour bed delineation for partial breast/breast boost radiotherapy: what is the optimal number of implanted markers? Radiother Oncol. 2013 Feb;106(2):231-5. doi: 10.1016/j.radonc.2013.02.003. Epub 2013 Mar 13.

    PubMed 23490269

  • Nichols EM, Dhople AA, Mohiuddin MM, Flannery TW, Yu CX, Regine WF. Comparative analysis of the post-lumpectomy target volume versus the use of pre-lumpectomy tumor volume for early-stage breast cancer: implications for the future. Int J Radiat Oncol Biol Phys. 2010 May 1;77(1):197-202. doi: 10.1016/j.ijrobp.2009.04.063.

    PubMed 20394853

  • Dindo D, Demartines N, Clavien PA. Classification of surgical complications: a new proposal with evaluation in a cohort of 6336 patients and results of a survey. Ann Surg. 2004 Aug;240(2):205-13. doi: 10.1097/01.sla.0000133083.54934.ae.

    PubMed 15273542

Questions about this trial

What is this clinical trial studying?

A study testing Tomotherapy in people with Breast Cancer, run by Andre Nazac at 3 sites in Belgium.

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 6 inclusion and 5 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: finished, as of the sponsor's last update on 20 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in Belgium. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Duration of the surgical procedure (time frame: from 2 to 8 days after the last radiotherapy session.). The study lists 6 primary outcomes in all. 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 NCT02858934, which also lists 10 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 20 Jul 2022.

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