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Breast CancerPhase 3ROLLNCT00539474

"The Efficacy of 'Radioguided Occult Lesion Localization' (ROLL) Versus 'Wire-guided Localization' (WGL) in Breast Conserving Surgery for Non-palpable Breast Cancer: a Randomized Clinical Trial"

A Phase 3 study testing Radio guided occult lesion localisation in people with Breast Cancer, run by UMC Utrecht at 4 sites in Netherlands.

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

Rationale: Approximately 25% of breast cancers detected are non palpable. Accordingly, a localization technique is required to help the surgeon to find and remove the cancer. The current technique (wire guided localization [WGL]) is difficult to perform and has a high rate of tumour positive margins in the resected… 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?
Radio guided occult lesion localisation
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
316 participants
Where
4 sitesNetherlands
Study dates
Jan 2008to Nov 2011
Phase
Phase 3
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

  • Women ≥ 18 years, with a non-palpable breast carcinoma (cT1) that need to be treated with a lumpectomy and sentinel node biopsy

Who cannot join

  • Pregnant patients or patients who breast feed
  • Patients with multi focal tumour growth
  • Patients with only ductal carcinoma in situ or lobular carcinoma in situ in the core biopsy
  • Patients requiring breast amputation

Trial locations and contacts

4 sites in 1 country.

Netherlands4 sites

  • Amphia hospital

    Breda, North Brabant, 4800 RK

  • st Antonius Hospital

    Nieuwegein, Utrecht, 3430 EM

  • Maasstad Ziekenhuis

    Rotterdam, South Holland, 3078 HT

  • University Medical Center

    Utrecht, Utrecht, 3584 CX

Other trials in Netherlands

About this study

Rationale:

Approximately 25% of breast cancers detected are non palpable. Accordingly, a localization technique is required to help the surgeon to find and remove the cancer. The current technique (wire guided localization [WGL]) is difficult to perform and has a high rate of tumour positive margins in the resected specimen, requiring a second operation. A new approach in the localization and resection of non-palpable malignant breast lesions is 'radio guided occult lesion localization' (ROLL). ROLL was introduced as a possible replacement for WGL at the 'European Institute of Oncology' in Milan in 1996. This technique utilizes the intratumourally injected radiotracer, that is generally used for the lymphatic mapping and SNB, to localize the primary tumour guided by the gamma probe. Five studies so far have proven the applicability of this method.

Read more

Objective:

To evaluate the efficacy of Radio Occult Lesion Localisation (ROLL) versus Wire guided Localisation (WGL) in breast conserving surgery for non-palpable breast cancer

Study design:

A multicenter, prospective randomized clinical trial. Patients with proven non-palpable breast cancer will be randomized for either ROLL or WGL.

Study population:

316 women with a core biopsy proven non palpable cT1 breast carcinoma that are eligible for a breast conserving treatment and sentinel node biopsy (SNB).

Intervention (if applicable):

Patients in the WGL group will undergo intra tumoural injection of a nuclear radiotracer under stereotactic or ultrasonographic guidance. After scintigraphic imaging, to monitor the migration of the radiotracer, a guide wire will be inserted under stereotactic or ultrasonographic guidance. The excision of the primary tumour is guided by the inserted wire and the sentinel node procedure is performed using a gamma probe and intratumoural injection of patent blue.

Patients in the ROLL group will undergo the same procedure except for the guide wire insertion. The excision of the primary tumour is guided by the gamma probe.

Main study parameters/endpoints:

Primary study endpoints; ROLL vs WGL:

  1. The percentage of tumour-free margins (invasive and in situ)
  2. The volume and maximum diameter of the lumpectomy

Nature and extent of the burden and risks associated with participation, benefit and group relatedness:

There is no pre-, per- or post operative extra burden. The radiofarmacon is already used in the standard care of breast cancer patients for the sentinel node biopsy. The used radio-active substance does not damage the patient.

A specific burden questionnaire, aimed at evaluating the burden of the cosmetic result, will be administered. To further assess the net impact in terms of Health Related Quality of Life (HRQoL) also the EQ5D will be obtained at T = 0, 6, 12 and 26 weeks after the initial diagnostic work-up.

Should the results indicate that overall the WGL procedure lead to better clinical outcome a cost-effectiveness analysis is foreseen using bootstrapping to assess the uncertainty with regard to the balance between costs and effects. All analyses will be limited to a half year time horizon. Accordingly, discounting of costs or effects is not applicable.

Conditions
Breast Cancer
Being tested
Radio guided occult lesion localisation
Keywords
ROLL trial, Minimally invasive surgery, Non palpable breast cancer
Medical subject headings
Breast Neoplasms

What participants receive

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

  • Radio guided occult lesion localisationProcedure or surgery

    ROLL procedure using the Europrobe (Europrobe, Strassbourg, France) WGL using a hook wire

Study groups in NCT00539474
Study groupRoleWhat they receive
1Active comparatorWireguided localisation
Receives: Procedure: Radio guided occult lesion localisation
2ExperimentalRadioguided occult lesion localisation
Receives: Procedure: Radio guided occult lesion localisation

What is being measured

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

  1. Radicality, oncologic outcome

    Measured: 3 years

Secondary outcomes (1)

  1. Doctors questionnaires Patients questionnaire cost-effectiveness analysis

    Measured: 24 weeks

Timeline

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

  1. First posted4 Oct 2007 (estimated)
  2. Study startJan 2008
  3. Primary completionJun 2010
  4. Study completionNov 2011

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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
316 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00539474
Sponsor's protocol ID
07/089
Other IDs
ZonMw grant: 80-82310-98-08004
Acronym
ROLL
Status last verified
Dec 2011
First submitted
3 Oct 2007
Last updated
23 Dec 2011
Results posted
No
Data monitoring committee
Yes

Publications

  • Postma EL, Koffijberg H, Verkooijen HM, Witkamp AJ, van den Bosch MA, van Hillegersberg R. Cost-effectiveness of radioguided occult lesion localization (ROLL) versus wire-guided localization (WGL) in breast conserving surgery for nonpalpable breast cancer: results from a randomized controlled multicenter trial. Ann Surg Oncol. 2013 Jul;20(7):2219-26. doi: 10.1245/s10434-013-2888-7. Epub 2013 Feb 23.

    PubMed 23435568

  • Postma EL, Verkooijen HM, van Esser S, Hobbelink MG, van der Schelling GP, Koelemij R, Witkamp AJ, Contant C, van Diest PJ, Willems SM, Borel Rinkes IH, van den Bosch MA, Mali WP, van Hillegersberg R; ROLL study group. Efficacy of 'radioguided occult lesion localisation' (ROLL) versus 'wire-guided localisation' (WGL) in breast conserving surgery for non-palpable breast cancer: a randomised controlled multicentre trial. Breast Cancer Res Treat. 2012 Nov;136(2):469-78. doi: 10.1007/s10549-012-2225-z. Epub 2012 Sep 30.

    PubMed 23053639

  • van Esser S, Hobbelink MG, Peeters PH, Buskens E, van der Ploeg IM, Mali WP, Rinkes IH, van Hillegersberg R. The efficacy of 'radio guided occult lesion localization' (ROLL) versus 'wire-guided localization' (WGL) in breast conserving surgery for non-palpable breast cancer: a randomized clinical trial - ROLL study. BMC Surg. 2008 May 21;8:9. doi: 10.1186/1471-2482-8-9.

    PubMed 18495027

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Radio guided occult lesion localisation in people with Breast Cancer, run by UMC Utrecht at 4 sites in Netherlands.

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 1 inclusion and 4 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 23 Dec 2011. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in Netherlands. 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.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

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?

Radicality, oncologic outcome (time frame: 3 years). 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 NCT00539474, which also lists 3 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 23 Dec 2011.

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