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Endocrine treatment with letrozole, with or without local 3D conformal radiotherapy (3DCRT) of metastatic lesions in postmenopausal patients with inoperable, hormone-sensitive, oligometastatic breast cancer: a multicentre, randomised phase II study
ISRCTN ISRCTN15692114
DOI 10.1186/ISRCTN15692114
ClinicalTrials.gov identifier
EudraCT number
Public title Endocrine treatment with letrozole, with or without local 3D conformal radiotherapy (3DCRT) of metastatic lesions in postmenopausal patients with inoperable, hormone-sensitive, oligometastatic breast cancer: a multicentre, randomised phase II study
Scientific title
Acronym LETROZOL-3DCRT
Serial number at source KKSH-13
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.
Lay summary Not provided at time of registration
Ethics approval Not provided at time of registration
Study design Randomised controlled trial
Countries of recruitment Germany
Disease/condition/study domain Inoperable, hormone-responsive, oligometastatic breast cancer
Participants - 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
Participants - 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
Anticipated start date 01/10/2005
Anticipated end date 01/10/2010
Status of trial Completed
Patient information material
Target number of participants 80
Interventions 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
Primary outcome measure(s) Progression-free survival as measured by the one-year progression-free survival rate
Secondary outcome measure(s) 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
Sources of funding German Federal Ministry of Education and Research (Bundesministerium Für Bildung und Forschung) (BMBF) (grant no. 01ZP0301/G)
Trial website
Publications
Contact name Prof  Christoph  Thomssen
  Address Martin-Luther-University Halle-Wittenberg

Medical Faculty

Department of Gynecology

Ernst-Grube Str. 40
  City/town Halle/Saale
  Zip/Postcode 06120
  Country Germany
Sponsor Martin-Luther-University (Germany)
  Address Universitätsplatz 10
  City/town Halle/Saale
  Zip/Postcode 06108
  Country Germany
  Sponsor website: www.verwaltung.uni-halle.de
Date applied 01/06/2005
Last edited 29/07/2014
Date ISRCTN assigned 05/07/2005
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