Intraoperative Electron Radiotherapy for Low-risk Early Breast Cancer

NCT ID: NCT03838419

Last Updated: 2024-01-05

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 202 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-10-01
• Study Completion Date: 2030-05-01

Brief Summary

Breast cancer is the most frequent malignancy in women. Standard therapy for early-stage breast cancer is breast conserving surgery (BCS) followed by adjuvant whole breast irradiation (WBI), which usually requires a treatment time of 3-6 weeks. Several randomized controlled trials (RCTs) demonstrated that postoperative WBI after BCS significantly decreased the risk of local (in-breast) recurrence and improved breast cancer mortality as well as survival. However, one of the most common side-effects of radiotherapy is fatigue, which is reported in up to 80% of cancer patients during treatment. Especially in early-stage breast cancer patients it might be the only serious side-effect following adjuvant irradiation, as fatigue often significantly reduces quality of life due to resulting functional impairment and psychological distress. Fatigue additionally has a distinct socioeconomic impact: 75% of patients and 40% of caregivers are forced to change their employment status due to cancer-related fatigue.

For reducing treatment-related toxicity, several RCTs consequently addressed the question whether adjuvant WBI could be omitted in early-stage, low risk breast cancer patients treated with endocrine therapy. However, all these trials detected up to seven-time increased local recurrence rates without WBI following BCS. Both, longer duration of radiotherapy and larger radiation field sizes are known to be associated with increase in treatment-related fatigue. Accelerated partial breast irradiation (APBI), delivered exclusively to the original tumor location and not to the surrounding breast tissue, might therefore be an alternative treatment option with fewer side-effects for early-stage, low risk breast cancer patients. Few previous trials have already reported comparable outcomes for highly selected low-risk breast cancer patients for APBI compared to conventional WBI. First results also point out that APBI compared to WBI might be associated with less severity and intensity of fatigue.

One method for APBI is single-dose intraoperative radiotherapy (IORT) delivered directly to the tumor after resection. Data is still limited for APBI, hence current international and German guidelines suggest the use of APBI for low-risk early stage breast cancer patients but recommend the application of APBI preferably within a clinical trial.

Conditions

Breast Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

BCS + WBI

breast conserving surgery followed by whole breast irradiation

Group Type: ACTIVE_COMPARATOR

whole breast irradiation

Intervention Type: RADIATION

hypofractionated WBI Total dose 40.05 Gy (15 x 2.67 Gy)

BCS + IORT

Breast conserving surgery incl intraoperative radiotherapy

Group Type: EXPERIMENTAL

intraoperative radiotherapy

Intervention Type: RADIATION

IORT with 21 Gy prescribed to the 90% isodose line

Interventions

intraoperative radiotherapy

IORT with 21 Gy prescribed to the 90% isodose line

Intervention Type: RADIATION

whole breast irradiation

hypofractionated WBI Total dose 40.05 Gy (15 x 2.67 Gy)

Intervention Type: RADIATION

Other Intervention Names

IORT; WBI

Eligibility Criteria

Inclusion Criteria

• Histologically confirmed invasive breast cancer
• Total tumor size < 2.5 cm
• cN0
• estrogen receptor positive, HER2-receptor negative on immunohistochemistry
• age >= 50 years
• ECOG (Eastern Cooperative Oncology Group) Performance status ≤ 2
• Ability of subject to understand character and individual consequences of the clinical trial
• Written informed consent (must be available before enrolment in the trial)

Exclusion Criteria

• G3
• Extensive microcalcifications
• Invasive lobular carcinoma
• Clinically involved lymph nodes
• No invasive axillary lymph node staging planned
• Patients with significant mental or physical comorbidities that preclude regular follow-up
• Neoadjuvant chemotherapy or neoadjuvant endocrine therapy
• previous radiotherapy of the breast
• Known carcinoma < 5 years ago (excluding Carcinoma in situ of the cervix, basal cell carcinoma, squamous cell carcinoma of the skin) requiring immediate treatment interfering with study therapy
• Pregnant or lactating women
• Participation in another competing clinical study or observation period of competing trials

• Minimum Eligible Age: 50 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

University Hospital Heidelberg

OTHER

Sponsor Role: lead

Responsible Party

Juergen Debus

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

University Hospital of Heidelberg, Radiation Oncology

Heidelberg, , Germany

Site Status: RECRUITING

Countries

Germany

Facility Contacts

Jürgen Debus, Prof. Dr.

Role: primary

juergen.debus@med.uni-heidelberg.de

+49-6221-56 ext. 8202

Adriane Hommertgen

Role: backup

adriane.hommertgen@med.uni-heidelberg.de

+49-6221-56 ext. 8202

References

Forster T, Jakel C, Akbaba S, Krug D, Krempien R, Uhl M, Hafner MF, Konig L, Koerber SA, Harrabi S, Bernhardt D, Behnisch R, Krisam J, Hennigs A, Sohn C, Heil J, Debus J, Horner-Rieber J. Fatigue following radiotherapy of low-risk early breast cancer - a randomized controlled trial of intraoperative electron radiotherapy versus standard hypofractionated whole-breast radiotherapy: the COSMOPOLITAN trial (NCT03838419). Radiat Oncol. 2020 Jun 1;15(1):134. doi: 10.1186/s13014-020-01581-9.

Reference Type: DERIVED

PMID: 32487184 (View on PubMed)

Other Identifiers

COSMOPOLITAN

Identifier Type: -

Identifier Source: org_study_id