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JOURNAL ONKOLOGIE – STUDIE

OLIGOMA Metastases-directed Radiotherapy in Addition to Standard Systemic Therapy in Patients With Oligometastatic Breast Cancer

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NCT-Nummer:
NCT04495309

Studienbeginn:
Oktober 2020

Letztes Update:
05.11.2020

Wirkstoff:
-

Indikation (Clinical Trials):
Breast Neoplasms

Geschlecht:
Frauen

Altersgruppe:
Erwachsene (18+)

Phase:
-

Sponsor:
University Hospital Schleswig-Holstein

Collaborator:
-

Studienleiter

Jürgen Dunst, Professor
Study Director
University Hospital Schleswig-Holstein

Kontakt

Studienlocations (3 von 4)

Praxis für Strahlentherapie und Radioonkologie am Krankenhaus Weilheim
82362 Weilheim
(Bayern)
Germany» Google-Maps
Ansprechpartner:
Monika Panzer, MD
Phone: 0049/88192452340
E-Mail: monika.panzer@strahlentherapie-weilheim.de
» Ansprechpartner anzeigen
Städtisches Klinikum Dresden, Strahlentherapie
01067 Dresden
(Sachsen)
Germany» Google-Maps
Ansprechpartner:
Andreas Schreiber, MD
Phone: 0049/3514803500
E-Mail: Andreas.Schreiber@klinikum-dresden.de

Jörg Zimmer, MD
Phone: 0049/3514803501
E-Mail: Zimmer-Jo@khdf.de
» Ansprechpartner anzeigen
Heinrich-Braun-Klinikum Zwickau gGmbH Klinik für Strahlentherapie und Radioonkologie
08060 Zwickau
(Sachsen)
Germany» Google-Maps
Ansprechpartner:
Alexander Boicev, MD
Phone: 0049/375512802
E-Mail: alexander.boicev@hbk-zwickau.de
» Ansprechpartner anzeigen
Christian-Albrechts-University Kiel, University Medical Center Schleswig-Holstein, Campus Kiel
24105 Kiel
(Schleswig-Holstein)
Germany» Google-Maps
Ansprechpartner:
Juergen Dunst, Prof.
Phone: 0049/431/50026500
E-Mail: Juergen.Dunst@uksh.de

Kathrin Dellas, Prof.
Phone: 0049/431/50026570
E-Mail: Kathrin.Dellas@uksh.de
» Ansprechpartner anzeigen
Alle anzeigen

Studien-Informationen

Detailed Description:

Preferably ablative radiotherapy (radiosurgery, stereotactic radiotherapy, hypofractionated

image-guided radiotherapy (IGRT)) with few high-dose fractions. Larger lesions or lesions

with critical normal tissue involvement should be treated with three-dimensional conformal

radiation therapy (3D-CRT) or intensity-modulated radiation therapy (IMRT) in moderate

hypofractionated radiotherapy (depending on the size and location of the target volume and

the decision of the radiooncologist). For critical organs in the target volume, standard

fractionated radiotherapy can be used.

Ein-/Ausschlusskriterien

Inclusion Criteria:

- Metastasized breast cancer - up to 5 clinically manifest (new, progressive,

persistent) metastases (a lymph node metastasis and a circumscribed local recurrence

are each considered as one metastasis, i.e. also locoregional recurrent breast

carcinomas with additional hematogenic metastasis possible)

- maximum of 3 cerebral metastases known

- indication for palliative drug therapy (endocrine therapy and/or chemotherapy and/or

treatment with other substances) given according to guidelines (1st-line or further

therapy lines, a special regime is not specified)

- Eastern Cooperative Oncology Group (ECOG) Performance Status ≤ 2

- local radiation of all metastases possible

- presentation of a written declaration of consent

- patient ≥ 18 years

Exclusion Criteria:

- Previous radiotherapy, if this interferes with treatment within the scope of the study

- symptomatic metastases requiring local therapy of all metastases (e.g. pain

radiation), a radiation indication (or other local therapy) for individual metastases

is not a criterion for exclusion

- known central nervous system (CNS) metastasis without extracerebral metastasis (in

these cases, immediate local therapy is mandatory)

- more than three known CNS metastases (no indication for purely local therapy of only

the metastases, primary whole brain radiation is indicated)

- multifocal metastasis in one organ with impossibility to comply with the dose

constraints for this organ (e.g., no indication for local therapy of only the

metastases, primary whole brain radiation is indicated) (e.g. in the liver)

- exclusively regional lymph node metastasis without haematogenic metastases (in these

cases local therapy is clearly indicated according to guidelines)

- relevant comorbidity, if this results in restrictions for further therapy

- Incapacity to contract or lack of informed consent

- Pregnancy and lactation

Studien-Rationale

Primary outcome:

1. First co-primary outcome measure is progression-free survival (PFS) (Time Frame - at least 12 months after randomization):
Co-primary progression-free survival (PFS) according to Response Evaluation Criteria In Solid Tumors (RECIST)

2. Second co-primary outcome measure is quality of life (Time Frame - 12 weeks after randomization):
Co-primary quality of life according to European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire for Cancer patients with 30 items (QLQ-C30) sum score

Secondary outcome:

1. Feasibility (per-protocol within intention-to-treat) (Time Frame - 12 weeks):
Proportion of participants treated per protocol

2. Overall survival (Time Frame - at least 1, up to 5 years):
Time between randomization and death

3. Toxicity (number and degree of reported toxicities in both treatment arms) (Time Frame - 0 to 5 years):
Proportion of participants with degree of toxicities as defined by National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) and by Radiation Treatment Oncology Group (RTOG) by point in time of follow-up with higher degree indicating higher intensity

4. Neoplasia-specific quality of life (Time Frame - quarterly up to 5 years):
Research and Treatment of Cancer (EORTC) Quality of Life Questionaire for Cancer patients with 30 items (QLQ-C30) with different scales

5. Breast cancer-specific quality of life (Time Frame - quarterly up to 5 years):
Research and Treatment of Cancer (EORTC) Quality of Life Questionaire for breast cancer patients with 23 items (QLQ-BR23) on 4-point Likert scales with different directions

6. Patient satisfaction (Time Frame - 12 weeks):
Research and Treatment of Cancer (EORTC) Patient satisfaction questionnaire for cancer patients with 33 items (PATSAT-C33) on 5-point Likert scale with higher scores indicating greater satisfaction

7. Frequency of adverse events (Time Frame - 0 to 5 years):
Number of patients with adverse and serious adverse events

Studien-Arme

  • No Intervention: Standard
    Standard of care, i. e. no local radiotherapy in addition to standard systemic therapy (exception: palliative local treatment of symptomatic lesions where indicated)
  • Experimental: Experimental
    Standard of care (standard systemic therapy) + study intervention

Geprüfte Regime

  • Metastases-directed Radiotherapy:
    Ablative radiotherapy (radiosurgery, stereotactic radiotherapy, hypofractionated image-guided radiotherapy (IGRT)) with few high-dose fractions

Quelle: ClinicalTrials.gov


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