Partial Breast Irradiation With Interstitial High Dose Rate Brachytherapy

NCT ID: NCT00499057

Last Updated: 2014-12-23

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 150 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2003-08-31
• Study Completion Date: 2016-08-31

Brief Summary

Partial breast irradiation (PBI) is becoming more widespread in the treatment of early breast cancer in patients at low risk of relapse as pathological and clinical findings have demonstrated that most breast cancer recurrences after BCS occur close to the tumour bed. In our phase II prospective study PBI is administered with high-dose-rate brachytherapy in patients with low-risk early-stage breast cancer. Patients receive 4 Gy twice a day for 4 days (total dose 32 Gy).

Detailed Description

Patients included in our phase II trial of PBI with interstitial HDR brachytherapy are at low-risk of relapse. Implants are positioned during surgery or postoperatively, within 12 weeks. Treatment schedule is 4 Gy twice a day, with a time relapse of at least 6 hours between each fraction, for four days, for a total dose 32 Gy. Before post-operative implantation, all patients undergo a breast computed tomography (CT) scan to visualize and expand the excision cavity and obtain the planning target volume (PTV), i.e. the lumpectomy cavity plus a margin of 1-2 cm around it. Through virtual simulation with a 3D treatment planning system (TPS), we define the implant catheter position. After implantation, in all patients a breast CT scan checked implant geometry. On CT images transferred to a TPS the surgical cavity is outlined and expanded, the PTV defined, and inactive and active source lengths measured.CT-based 3D software is used to identify and reconstruct the catheters, outline and expand the surgical cavity and obtain the PTV. Dwell positions are activated for each catheter, and inactive and active lengths defined.Prescribed dose was 85% of the basal dose. Dwell weights are optimised in the basal points applying the volume and distance method and best values were chosen independently of strategy. A dose-volume histogram that records the volume covered by 100% and 150% of the prescribed dose (V100 and V150) was obtained for each patient. DHI, defined as V150 - V100/ V100 (7), is recognized as the most suitable quality index.

Conditions

Breast Cancer

Keywords

early stage breast cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

single arm study

single arm study

Group Type: OTHER

interstitial high dose-rate brachytherapy, PBI

Intervention Type: RADIATION

Single arm study Treatment schedule is 4 Gy twice a day, with a time relapse of at least 6 hours between each fraction, for four days, for a total dose 32 Gy.

Interventions

interstitial high dose-rate brachytherapy, PBI

Single arm study Treatment schedule is 4 Gy twice a day, with a time relapse of at least 6 hours between each fraction, for four days, for a total dose 32 Gy.

Intervention Type: RADIATION

Eligibility Criteria

Inclusion Criteria

• Age > or = 40 years
• ECOG performance status 0-2
• T dimensions ≤ 2.5 cm
• Negative surgical margins
• Negative axillary lymph nodes
• Suitable breast anatomy for implantation

Exclusion Criteria

• Age < 40 years
• ECOG performance status > 2
• T dimensions > 2.5
• Positive surgical margins
• Positive axillary lymph node
• Infiltrating lobular histology
• Significant areas of lobular carcinoma in situ
• Paget's disease of the nipple
• Extensive intraductal component (EIC)
• Lymphovascular invasion
• Multifocality (n) skin infiltration

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

University Of Perugia

OTHER

Sponsor Role: lead

Responsible Party

Cynthia Aristei

Full Professor of Rdaiotherapy

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Cynthia Aristei, Prof. M.D.

Role: STUDY_DIRECTOR

University Of Perugia

Locations

Radiation Oncology Institute

Perugia, Perugia, Italy

Site Status: RECRUITING

Countries

Italy

Central Contacts

Cynthia Aristei, Prof. M.D.

Role: CONTACT

Phone: 00390755784306

Email: cynthia.aristei@unipg.it

Facility Contacts

Cynthia Aristei, Prof. M.D.

Role: primary

References

Aristei C, Palumbo I, Capezzali G, Farneti A, Bini V, Falcinelli L, Margaritelli M, Lancellotta V, Zucchetti C, Perrucci E. Outcome of a phase II prospective study on partial breast irradiation with interstitial multi-catheter high-dose-rate brachytherapy. Radiother Oncol. 2013 Aug;108(2):236-41. doi: 10.1016/j.radonc.2013.08.005. Epub 2013 Sep 14.

Reference Type: DERIVED

PMID: 24044802 (View on PubMed)

Other Identifiers

BRT-HDR

Identifier Type: -

Identifier Source: org_study_id