Hyperthermia and Proton Therapy in Unresectable Soft Tissue Sarcoma (HYPROSAR)
|Soft Tissue Sarcoma||Radiation: Hyperthermia and Proton Beam||Phase 1 Phase 2|
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase I/II Study of Concurrent Hyperthermia and Proton Beam Radiotherapy in Primary and Recurrent Unresectable Soft Tissue Sarcoma|
- To evaluate safety of hyperthermia and proton beam treatment in unresectable soft tissue sarcomas [ Time Frame: 6 months from end of treatment ]Acute and late morbidities of the treatment would be evaluated according to the CTCAE 4.0 guidelines during and until 6 months after the treatment
- To evaluate the local response to hyperthermia and proton beam therapy as a preoperative regimen for unresectable soft tissue sarcomaLocal control [ Time Frame: 6 months following the completion of study treatment ]Imaging response according to RECIST criteria comparing pretreatment MRI versus post treatment MRI taken 4 to 6 weeks after completion of the study treatment.
- Local disease free survival [ Time Frame: Would be assessed every 6 monthly up to a maximum of 48 months ]Local disease free survival would be computed using the Kaplan-Meir survival statistics
|Study Start Date:||February 2014|
|Estimated Study Completion Date:||December 2018|
|Estimated Primary Completion Date:||February 2018 (Final data collection date for primary outcome measure)|
Patients subjected to the planned therapeutic intervention of local hyperthermia and proton beam therapy
Radiation: Hyperthermia and Proton Beam
Hyperthermia would be delivered at Kantonsspital Aarau (KSA) with superficial or deep hyperthermia treatment units as may be appropriate. All patients would undergo a pre-hyperthermia treatment planning and a temperature of around 41.5 Centigrade to 42.5 Centigrade would be aimed during hyperthermia sessions.Hyperthermia would be delivered once a week and the treatment sessions would last for around 60 minutes of active heating.
Proton bean therapy would be carried out at Center of Proton Therapy, Paul Scherrer Institute (PSI), Villigen using scanning beam proton therapy. A preoperative dose of 55 - 60 Gray equivalent (GyE) or those considered for radical treatment, 72-76 GyE would be delivered, 5 days a week at 1.8 - 2 Gy/fr.
On days of both hyperthermia at KSA and proton therapy at PSI, the time interval between the two treatments could be 90 to 150 minutes, taking into consideration the time to travel between the two institutions. Hyperthermia in these days would follow proton beam therapy.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01904565
|Contact: Niloy R Datta, MD, DNB,||+41-62 firstname.lastname@example.org|
|Contact: Stephan Bodis, MD||+41-62 838 email@example.com|
|Aarau, Aargau, Switzerland, CH 5001|
|Contact: Niloy R Datta, MD, DNB, CCST 0041 62 8389559 firstname.lastname@example.org|
|Contact: Emsad Puric, MD 0041 92 85385 Emsad.Puric@ksa.ch|
|Principal Investigator: Niloy R Datta, MD, DNB|
|Principal Investigator:||Niloy R Datta, MD, DNB||Kantonsspital Aarau, Switzerland|