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

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT03262220
• Date of registration: 23/08/2017
• Prospective Registration: No
• Primary sponsor: Thomas Zilli
• Public title: Total Marrow Irradiation With Volumetric Arc Therapy for Patients Unfit for a 12 Gy TBI
• Scientific 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.
• Date of first enrolment: April 11, 2017
• Target sample size: 10
• Recruitment status: Recruiting
• URL: https://clinicaltrials.gov/show/NCT03262220
• Study type: Interventional
• Study design: Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: N/A

Countries of recruitment

Switzerland

Contacts

• Name: Thomas Zilli, MD

• Name: Thomas Zilli, MD

Key inclusion & exclusion criteria

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.



Age minimum: 40 Years
Age maximum: 80 Years
Gender: All

Health Condition(s) or Problem(s) studied

Haematological Malignancy

Intervention(s)

Radiation: Volumetric Arc Therapy (VMAT)

Primary Outcome(s)

Grade II and III toxicity [Time Frame: 30 days after radiotherapy]

Secondary Outcome(s)

Cumulative incidence of Transplant Related Mortality(TRM) [Time Frame: 100 days post-bone marrow transplantation]

Cumulative incidence of Grade II Organ toxicity [Time Frame: up to day 100 post-bone marrow transplantation]

Secondary ID(s)

2017-00066

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

University Hospital, Geneva