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

NCT03262220 | Unknown DMC

• 1 other identifier: 2017-00066
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Haematological Malignancy

Keywords

Haematological malignancy; Total Marrow Irradiation; Volumetric Arc Therapy

Outcome Measures

Primary Outcomes (1)

• Grade II and III toxicity

  (Seattle Regimen-related toxicity grade) 30 days after transplant in patients with hematologic malignancies treated with a dose-escalated hypofractionated VMAT-based TMI

  30 days after radiotherapy

Secondary Outcomes (2)

• Cumulative incidence of Transplant Related Mortality(TRM)

  100 days post-bone marrow transplantation

• Cumulative incidence of Grade II Organ toxicity

  up to day 100 post-bone marrow transplantation

Interventions

Volumetric Arc Therapy (VMAT) RADIATION

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).

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Thomas Zilli: lead
• University Hospital, Geneva: collaborator

Study Sites (1)

University Hospital of Geneva

Geneva, 1205, Switzerland

RECRUITING

MeSH Terms

Conditions

Hematologic Neoplasms

Interventions

Radiotherapy, Intensity-Modulated

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Radiotherapy, Conformal; Radiotherapy, Computer-Assisted; Radiotherapy; Therapeutics

Central Study Contacts

Thomas Zilli, MD

CONTACT

+ 41 79 55 32 563; thomas.zilli@hcuge.ch

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: MD, PD, Médecin Adjoint Agrégé

Study Record Dates

• First Submitted: August 23, 2017
• First Posted: August 25, 2017
• Study Start: April 11, 2017
• Primary Completion: April 1, 2021
• Study Completion: April 1, 2025
• Last Updated: May 14, 2020

Record last verified: 2020-05

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)