Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Christoph Thomssen

ORCID ID

Contact details

Martin-Luther-University Halle-Wittenberg
Medical Faculty
Department of Gynecology
Ernst-Grube Str. 40
Halle/Saale
06120
Germany

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

KKSH-13

Study information

Scientific title

Acronym

LETROZOL-3DCRT

Study hypothesis

Local 3D conformal radiotherapy to metastatic sites, in addition to systemic treatment with letrozole, improves progression-free survival in postmenopausal, hormone-receptor positive patients with oligometastatic breast cancer.

Ethics approval

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Inoperable, hormone-responsive, oligometastatic breast cancer

Intervention

Endocrine treatment with letrozole 2.5 mg po (orally) daily in both study arms, additional local 3DCRT (50 Gy) to metastatic lesions in the experimental arm

Intervention type

Other

Phase

Phase II

Drug names

Primary outcome measures

Progression-free survival as measured by the one-year progression-free survival rate

Secondary outcome measures

1. Objective tumor response rate
2. Toxicity
3. 1-, 2-, 3-year survival rates
4. Clinical benefit (defined as proportion of patients with stable disease [SD] >24 weeks, complete response [CR] and partial response [PR])
5. Quality of life, as measured by European Organisation for Research and Treatment of Cancer (EORTC) quality of life questionnaires (QLQ) C30 and BR-23

Overall trial start date

01/10/2005

Overall trial end date

01/10/2010

Reason abandoned

Eligibility

Participant inclusion criteria

1. Postmenopausal women with histologically or cytologically confirmed, oligometastatic breast cancer, defined as: ≤3 metastatic lesions, or primary tumor and ≤2 metastatic lesions not amenable to curative surgery for medical or surgical reasons
2. No prior endocrine therapy for metastatic disease
3. Estrogen receptor and/or progresterone receptor positive status or with both receptors unknown
4. Measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST) (except patients with metastatic lesions confined to the bones who may be included in case or non-measurable but assessable disease)
5. Age >18 years, Eastern Cooperative Oncology Group (ECOG) 0-2
6. Adequate hematological, renal and hepatic function

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

80

Participant exclusion criteria

1. Central nervous system (CNS) metastasis or other metastasis in anatomic proximity to peripheral nerves precluding the delivery of the planned radiotherapy
2. Patients requiring immediate treatment with chemotherapy due to extensive visceral involvement or marked clinical symptoms
3. Malignant ascites, pericardial or pleural effusions, malignant infiltration of the bone marrow
4. Malabsorption syndrome or other uncontrolled medical conditions

Recruitment start date

01/10/2005

Recruitment end date

01/10/2010

Locations

Countries of recruitment

Germany

Trial participating centre

Martin-Luther-University Halle-Wittenberg
Halle/Saale
06120
Germany

Sponsor information

Organisation

Martin-Luther-University (Germany)

Sponsor details

Universitätsplatz 10
Halle/Saale
06108
Germany

Sponsor type

University/education

Website

www.verwaltung.uni-halle.de

Funders

Funder type

Government

Funder name

German Federal Ministry of Education and Research (Bundesministerium Für Bildung und Forschung) (BMBF) (grant no. 01ZP0301/G)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Editorial Notes