Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| University Hospital, Geneva | OTHER |
Not provided
Not provided
Not provided
Not provided
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.
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).
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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). |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Cumulative incidence of Grade II Organ toxicity |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Thomas Zilli, MD | Contact | + 41 79 55 32 563 | thomas.zilli@hcuge.ch |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital of Geneva | Recruiting | Geneva | 1205 | Switzerland |
No plan
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D019337 | Hematologic Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D050397 | Radiotherapy, Intensity-Modulated |
| ID | Term |
|---|---|
| D020266 | Radiotherapy, Conformal |
| D011881 | Radiotherapy, Computer-Assisted |
| D011878 | Radiotherapy |
| D013812 | Therapeutics |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Seattle Regimen-related toxicity grade |
| up to day 100 post-bone marrow transplantation |