Clinical trial NCT00539474: "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"
Official title: "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"
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Breast Cancer
Keywords: ROLL trial
Minimally invasive surgery
Non palpable breast cancer
Lead sponsor: UMC Utrecht
Sponsor class: OTHER
First posted: 2007-10-04
Enrollment: 316
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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 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.

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.


Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Radicality, oncologic outcome
timeFrame: 3 years
Secondary outcomes:
measure: Doctors questionnaires Patients questionnaire cost-effectiveness analysis
timeFrame: 24 weeks
Other outcomes:
Locations:
city: Breda
country: Netherlands
facility: Amphia hospital
state: Brabant
city: Nieuwegein
country: Netherlands
facility: st Antonius Hospital
state: Utrecht
city: Rotterdam
country: Netherlands
facility: Maasstad Ziekenhuis
state: Zuid-Holland
city: Utrecht
country: Netherlands
facility: University Medical Center
Study officials:
affiliation: UMCU
name: R van Hillegersberg, dr
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.