"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"

Breast Cancer Clinical Trial

— ROLL  

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"

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00539474
• Other study ID #: 07/089
• Secondary ID: ZonMw grant: 80-
• Status: Completed
• Phase: Phase 3
• First received: October 3, 2007
• Last updated: December 22, 2011
• Start date: January 2008
• Est. completion date: November 2011

Study information

• Verified date: December 2011
• Source: UMC Utrecht
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: Medical Ethics Review Committee (METC)
• Study type: Interventional

Clinical 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 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 316
• Est. completion date: November 2011
• Est. primary completion date: June 2010
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Procedure:
• Radio guided occult lesion localisation
ROLL procedure using the Europrobe (Europrobe, Strassbourg, France) WGL using a hook wire

Locations

Country	Name	City	State
Netherlands	Amphia hospital	Breda	Brabant
Netherlands	st Antonius Hospital	Nieuwegein	Utrecht
Netherlands	Maasstad Ziekenhuis	Rotterdam	Zuid-Holland
Netherlands	University Medical Center	Utrecht

Sponsors (1)

Lead Sponsor	Collaborator
UMC Utrecht

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Radicality, oncologic outcome		3 years	No
Secondary	Doctors questionnaires Patients questionnaire cost-effectiveness analysis		24 weeks	No