Total Marrow Irradiation With Volumetric Arc Therapy for Patients Unfit for a 12 Gy TBI

Studien-Informationen Einschlusskriterien Studien-Rationale Geprüfte Regime

Rekrutierend

NCT-Nummer:
NCT03262220

Studienbeginn:
April 2017

Letztes Update:
14.05.2020

Wirkstoff:
-

Indikation (Clinical Trials):
Neoplasms, Hematologic Neoplasms

Geschlecht:
Alle

Altersgruppe:
Erwachsene (18+)

Phase:
-

Sponsor:
Thomas Zilli

Collaborator:
University Hospital, Geneva

Kontakt

Thomas Zilli, MD
Kontakt:
Phone: + 41 79 55 32 563
E-Mail: thomas.zilli@hcuge.ch» Kontaktdaten anzeigen

Studienlocations
(1 von 1)

University Hospital of Geneva
1205 Genève
SwitzerlandRekrutierend» Google-Maps
Ansprechpartner:
Thomas Zilli, MD
Phone: +41 79 55 32 563
E-Mail: thomas.zilli@hcuge.ch» Ansprechpartner anzeigen

Studien-Informationen

Detailed Description:

This is a feasibility prospective pilot study. Ten patients ≥ 40 years with hematologic

malignancies prior to Bone Marrow Transplant (BMT) will receive a dose escalated

hypofractionated Total Marrow Irradiation (TMI) (12 Gy in 3 fractions, daily, on 3

consecutive days).

The current project is a joint initiative in translational and clinical medical research

between the Radiation-oncology workgroup and the Bone Marrow transplant workgroup of

University Hospitals of Geneva (HUG).

Ein-/Ausschlusskriterien

Inclusion Criteria:

- Karnofsky performance status ≥ 70

- Presence of any kind of haematological malignancy in complete remission (CR1, CR2 ore

CR3) at time of transplantation, with the exception of patients with myelodysplastic

syndrome.

- Patients that are scheduled for a BMT either using stem cell derived from bone marrow

or peripheral blood stem cells.

- Candidates to receive a 10 Gy TBI treatment.

- Ability to stay still and lying on the treatment couch for at least 45 minutes.

- Informed Consent as documented by signature.

Exclusion Criteria:

- Karnofsky performance status <70 intended as a patient unable to work; able to live at

home and care for most personal needs with varying amount of assistance needed.

- Concurrent treatment with other experimental drugs or other anti-cancer therapy.

- Participation in another clinical trial and any concurrent treatment with any

investigational drug within 4 weeks prior to trial entry/randomisation.

- Inability to comply with study and follow-up procedures.

Studien-Rationale

Primary outcome:

1. Grade II and III toxicity (Time Frame - 30 days after radiotherapy):
(Seattle Regimen-related toxicity grade) 30 days after transplant in patients with hematologic malignancies treated with a dose-escalated hypofractionated VMAT-based TMI

Secondary outcome:

1. Cumulative incidence of Transplant Related Mortality(TRM) (Time Frame - 100 days post-bone marrow transplantation):
Defined as death occurring from causes that are different other than disease relapse post-transplant

2. Cumulative incidence of Grade II Organ toxicity (Time Frame - up to day 100 post-bone marrow transplantation):
Seattle Regimen-related toxicity grade

Geprüfte Regime

Volumetric Arc Therapy (VMAT):
Total Marrow Irradiation: 12 Gy in 3 fractions of 4 Gy on 3 consecutive days with a concomitant simultaneous integrated boost (SIB) of 4.5 Gy x 3 fractions delivered to active bone marrow (ABM).

Quelle: ClinicalTrials.gov

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