Status:
UNKNOWN
Total Marrow Irradiation With Volumetric Arc Therapy for Patients Unfit for a 12 Gy TBI
Lead Sponsor:
Thomas Zilli
Collaborating Sponsors:
University Hospital, Geneva
Conditions:
Haematological Malignancy
Eligibility:
All Genders
40-80 years
Phase:
NA
Brief Summary
Total body irradiation (TBI) is a standard part of the conditioning regimen for bone marrow transplantation (BMT). Several randomized trials have shown superior outcomes using TBI compared with non TB...
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 I...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
April 11 2017
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2025
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT03262220
Start Date
April 11 2017
End Date
April 1 2025
Last Update
May 14 2020
Active Locations (1)
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1
University Hospital of Geneva
Geneva, Switzerland, 1205