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

Haematological Malignancy Clinical Trial

Official title:

Pilot Study of Dose Escalated Total Marrow Irradiation With Volumetric Arc Therapy for Patients With Hematological Malignancies Unfit for a Standard 12 Gy TBI Conditioning Regimen.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03262220
• Other study ID #: 2017-00066
• Status: Recruiting
• Phase: N/A
• Start date: April 11, 2017
• Est. completion date: April 2025

Study information

• Verified date: May 2020
• Source: University Hospital, Geneva
• Contact: Thomas Zilli, MD
• Phone: + 41 79 55 32 563
• Email: thomas.zilli[@]hcuge.ch
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10
• Est. completion date: April 2025
• Est. primary completion date: April 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Haematological Malignancy
• Hematologic Neoplasms
• Neoplasms

Intervention

Radiation:
• 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).

Locations

Country	Name	City	State
Switzerland	University Hospital of Geneva	Genève

Sponsors (2)

Lead Sponsor	Collaborator
Thomas Zilli	University Hospital, Geneva

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Cumulative incidence of Transplant Related Mortality(TRM)	Defined as death occurring from causes that are different other than disease relapse post-transplant	100 days post-bone marrow transplantation
Secondary	Cumulative incidence of Grade II Organ toxicity	Seattle Regimen-related toxicity grade	up to day 100 post-bone marrow transplantation