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

Last updated: May 13, 2020
Sponsor: Thomas Zilli
Overall Status: Active - Recruiting

Phase

N/A

Condition

Neoplasms

Hematologic Neoplasms

Treatment

N/A

Clinical Study ID

NCT03262220
2017-00066
  • Ages 40-80
  • All Genders

Study 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 TBI-containing regimens. Standard TBI is usually delivered over three days for a total dose of 12 Gy with two daily fractions. However, as demonstrated by our group, increasing the TBI dose above 10 Gy is not necessarily associated with better outcome in patients undergoing allogenic BMT for hematologic malignancies. For this reason, patients older than 40 or grafted after relapse are treated at our center with a reduced-dose 10 Gy TBI regimen. This pilot study wishes to investigate in 10 patients with hematological malignancies unfit for a standard 12 Gy TBI conditioning regimen a more targeted, conformal form of treatment, referred as total marrow (TMI), using volumetric Arc Therapy (VMAT). Our hypothesis is that using this technique that can allow deliver a higher total dose to the target while at the same time assuring to the organs at risk (OAR) the same dose normally delivered with a 10 Gy TBI we will improve the therapeutic ratio in these patients.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Karnofsky performance status ≥ 70

  • Presence of any kind of haematological malignancy in complete remission (CR1, CR2 oreCR3) at time of transplantation, with the exception of patients with myelodysplasticsyndrome.

  • Patients that are scheduled for a BMT either using stem cell derived from bone marrowor 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

Exclusion Criteria:

  • Karnofsky performance status <70 intended as a patient unable to work; able to live athome 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 anyinvestigational drug within 4 weeks prior to trial entry/randomisation.

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

Study Design

Total Participants: 10
Study Start date:
April 11, 2017
Estimated Completion Date:
April 30, 2025

Study 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).

Connect with a study center

  • University Hospital of Geneva

    Genève, 1205
    Switzerland

    Active - Recruiting

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