## Protocol Section
### Identification Module
**NCT ID:** NCT01403779

**Acronym:** KOSIMA

**Brief Title:** Comparison of the Cosmetic Outcome of Hypofractionated Versus Normofractionated IMRT in Treatment of Breast Cancer

**Official Title:** Comparison of the Cosmetic Outcome of Hypofractionated Versus Normofractionated Intensity Modulated Radiotherapy (IMRT) in Treatment of Breast Cancer: The KOSIMA Trial

#### Organization Study ID Info
**ID:** MA-KOSIMA-01
#### Organization
**Class:** OTHER
**Full Name:** Universitätsmedizin Mannheim
#### Secondary ID Infos
**Domain:** Arbeitsgemeinschaft Radiologische Onkologie der Deutschen Krebsgesellschaft
**ID:** ARO 2010-3
**Type:** OTHER
### Status Module
#### Completion Date
**Date:** 2017-02-02

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2022-11-07

**Type:** ACTUAL

**Last Update Submit Date:** 2022-11-02

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2017-02-02

**Type:** ACTUAL

#### Start Date
**Date:** 2010-07

**Status Verified Date:** 2022-11

#### Study First Post Date
**Date:** 2011-07-27
**Type:** ESTIMATED
**Study First Submit Date:** 2010-10-29
**Study First Submit QC Date:** 2011-07-26
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Universitätsmedizin Mannheim

#### Responsible Party

**Investigator Affiliation:** Universitätsmedizin Mannheim

**Investigator Full Name:** Frederik Wenz

**Investigator Title:** Prof. Dr.

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Oversight Has DMC:** False

### Description Module

**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 Module

**Conditions:**

- Tumors

- Breast Cancer

**Keywords:**

- Intensity-Modulated Radiation Therapy (IMRT)

- Breast cancer

- Hypofractionation

### Design Module

#### Design Info

**Allocation:** NON_RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** NONE

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 226

**Type:** ACTUAL

**Phases:**

- PHASE3

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** hypofractionated IMRT for right sided breast cancer

**Intervention Names:**

- Radiation: intensity modulated radiotherapy (IMRT) for breast cancer

**Label:** 1-Hypofractionated IMRT

**Type:** ACTIVE_COMPARATOR

#### Arm Group 2

**Description:** normofractionated IMRT for left sided breast cancer

**Intervention Names:**

- Radiation: intensity modulated radiotherapy (IMRT) for breast cancer

**Label:** 2-Normofractioated IMRT

**Type:** ACTIVE_COMPARATOR

### Interventions

#### Intervention 1

**Arm Group Labels:**

- 1-Hypofractionated IMRT

- 2-Normofractioated IMRT

**Description:** 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).

**Name:** intensity modulated radiotherapy (IMRT) for breast cancer

**Other Names:**

- Arm 1, Arm 2

**Type:** RADIATION

### Outcomes Module

#### Primary Outcomes

**Measure:** acute and chronic cosmetic outcome

**Time Frame:** 2 years

#### Secondary Outcomes

**Measure:** acute and chronic cosmetic outcome, Quality of life

**Time Frame:** 2 years

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

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

Exclusion Criteria:

* 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

**Minimum Age:** 60 Years

**Sex:** FEMALE

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Mannheim

**Country:** Germany

**Facility:** Department of Radiotherapy University Hospital Mannheim

**Zip:** 68167

#### Overall Officials

**Official 1:**

**Affiliation:** UMM

**Name:** Frederik Wenz, MD

**Role:** STUDY_CHAIR

### References Module

#### References

**Citation:** 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

#### See Also Links

**Label:** German Abstract

**URL:** https://doi.org/10.1055/s-0033-1347536

**Label:** English Abstract

**URL:** http://dx.doi.org/10.1016/j.ijrobp.2013.06.552

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000009371

- Term: Neoplasms by Site

- ID: D000009369

- Term: Neoplasms

- ID: D000001941

- Term: Breast Diseases

- ID: D000012871

- Term: Skin Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC04

- Name: Neoplasms

- Abbrev: BC17

- Name: Skin and Connective Tissue Diseases

- Abbrev: All

- Name: All Conditions

### Condition Browse Module - Browse Leaves

- ID: M5220

- Name: Breast Neoplasms

- Relevance: HIGH

- As Found: Breast Cancer

- ID: M5218

- Name: Breast Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M15674

- Name: Skin Diseases

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000001943

- Term: Breast Neoplasms

### Misc Info Module

- Version Holder: 2024-05-24
