Comparison of the Cosmetic Outcome of Hypofractionated Versus Normofractionated IMRT in Treatment of Breast Cancer

NCT01403779 | Completed Phase 3

• 2 other identifiers: MA-KOSIMA-01ARO 2010-3
• Study Type: interventional
• Target: 226
• Locations: 1 country
• Sites: 1

Brief Summary

Several multicenter studies have shown the equivalence of hypofractionated radiotherapy and normofractionated radiotherapy after breast-conserving surgery. However, the treatment in these studies was carried out with conventional techniques and not with the modern IMRT. Also the evaluation of quality of life and cosmetic outcome were not standardized. This study is a two-arm prospective study comparing normofractionated and hypofractionated radiotherapy in patients with breast cancer using tangential IMRT techniques. The primary endpoints are acute and chronic cosmetic breast changes. The secondary endpoint is the patients' quality of life. Patients to be included are breast cancer 60 years old patients or older with tumour stages pTis-pT3, pN0-pN1a, M0 after breast-conserving surgery. Patients with right sided breast cancer are stratified to receive a hypofractionated treatment course (40.05 / 2.67Gy in 15 fractions) and the left sided breast cancer a normofractionated irradiation (50/2Gy in 25 fractions). In both arms, patients between 60-69 years are to receive a boost (16 Gy / 2Gy). In both groups, a tangential intensity-modulated radiation technique aiming to achieve optimal dose homogeneity is applied. Since higher single radiation dose to the heart can lead to higher morbidity and/or mortality, patient stratification according to the diseased side was adopted where the left-sided breast cancer patients would receive normofractionated 2Gy single dose. Therefore there is no randomization. For classification and grading of adverse cosmetic events, the "Common Toxicity Criteria (CTC-AE V3.0) and the recognized LENT-SOMA scores are to be regularly documented. Quality of life is to be documented with two standardized, validated questionnaires "QLQ C30 and BR23" of the EORTC (European Organization for Research and Treatment of Cancer). The questionnaires are to be filled by the patients themselves at different time points during the study period. A sum of grade III fibrosis, grade III telangiectasia and grade II hyperpigmentation of around 20% is expected after 2 years. Therefore, calculation of the required number of cases based on an alpha of 0.05 and a power of 80% with a maximal tolerable toxicity difference of 15% within 2 years results in the need for recruiting 226 patients (113 in each arm) (non-inferiority of hypofractionated therapy).

Conditions

Tumors; Breast Cancer

Keywords

Intensity-Modulated Radiation Therapy (IMRT); Breast cancer; Hypofractionation

Outcome Measures

Primary Outcomes (1)

• acute and chronic cosmetic outcome

  2 years

Secondary Outcomes (1)

• acute and chronic cosmetic outcome, Quality of life

  2 years

Study Arms (2)

1-Hypofractionated IMRT

ACTIVE COMPARATOR

hypofractionated IMRT for right sided breast cancer

Radiation: intensity modulated radiotherapy (IMRT) for breast cancer

2-Normofractioated IMRT

ACTIVE COMPARATOR

normofractionated IMRT for left sided breast cancer

Radiation: intensity modulated radiotherapy (IMRT) for breast cancer

Interventions

intensity modulated radiotherapy (IMRT) for breast cancer RADIATION

right sided breast cancer patients are stratified to receive a hypofractionated treatment course (40.05 / 2.67Gy in 15 fractions) and the left sided breast cancer patients a normofractionated irradiation (50/2Gy in 25 fractions). In both arms, patients between 60-69 years are to receive a boost (16 Gy / 2Gy).

Also known as: Arm 1, Arm 2

1-Hypofractionated IMRT; 2-Normofractioated IMRT

Eligibility Criteria

• Age: 60 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically confirmed invasive or in situ breast cancer, tumor stage pTis-pT3, pN0-1a, M0
• Age ≥ 60 years
• signed informed consent from the patient

You may not qualify if:

• Stage pN1b-PN3, pT4 and / or M1
• incomplete surgical resection
• after mastectomy of the ipsilateral or contralateral breast
• breast reconstruction with implant or expander insert
• bilateral breast cancer
• Lack of compliance or consent
• Indications for irradiation of the axillary, supraclavicular or parasternal lymph nodes

Sponsors & Collaborators

• Universitätsmedizin Mannheim: lead

Study Sites (1)

Department of Radiotherapy University Hospital Mannheim

Mannheim, 68167, Germany

Location

Related Publications (1)

• Sarria GR, Welzel G, Polednik M, Wenz F, Abo-Madyan Y. Prospective Comparison of Hypofractionated Versus Normofractionated Intensity-Modulated Radiotherapy in Breast Cancer: Late Toxicity Results of the Non-Inferiority KOSIMA Trial (ARO2010-3). Front Oncol. 2022 May 5;12:824891. doi: 10.3389/fonc.2022.824891. eCollection 2022.

  PMID: 35600361 RESULT

Related Links

• German Abstract
• English Abstract

MeSH Terms

Conditions

Neoplasms; Breast Neoplasms

Interventions

Radiotherapy, Intensity-Modulated

Condition Hierarchy (Ancestors)

Neoplasms by Site; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Radiotherapy, Conformal; Radiotherapy, Computer-Assisted; Radiotherapy; Therapeutics

Study Officials

• Frederik Wenz, MD

  UMM

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr.

Study Record Dates

• First Submitted: October 29, 2010
• First Posted: July 27, 2011
• Study Start: July 1, 2010
• Primary Completion: February 2, 2017
• Study Completion: February 2, 2017
• Last Updated: November 7, 2022

Record last verified: 2022-11

Locations

DE (1)