Soft Tissue SarcomaPhase 1/2HYPROSARNCT01904565
Hyperthermia and Proton Therapy in Unresectable Soft Tissue Sarcoma
A Phase 1/2 study testing Hyperthermia and Proton Beam in people with Soft Tissue Sarcoma, run by Kantonsspital Aarau at 1 site in Switzerland.
Trial summary
This is a multi-institutional phase I/II clinical trial with concomitant local hyperthermia and proton beam radiotherapy in patients with primary or recurrent unresectable soft tissue sarcomas of the extremities, trunk, retroperitoneum (except intrabdominal). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Soft Tissue Sarcoma
- What is being tested?
- Hyperthermia and Proton Beam
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteSwitzerland
- Study dates
- Feb 2014to Dec 2018
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histopathologically proven and classified soft tissue sarcoma (STS) as per the WHO classification (2002). For all primary tumours, biopsy would be done within 2 months prior to registration and reviewed by the study pathologist. For all recurrent tumours, if prior biopsy has been done elsewhere, the histopathology would be reviewed by the study pathologist.
- Primary STS of extremities, trunk (except intrabdominal) and retroperitoneal which are,
- Deemed inoperable by the study surgeon
- Not feasible for a limb sparing surgery with possible R0/R1 resection as per the study surgeon,
- Patient medically unfit to undergo surgery
- Patient refuses surgery
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- Recurrent STS extremities and trunk would be eligible if
- Deemed inoperable by the study surgeon
- Not feasible for a limb sparing surgery with possible R0/R1 resection as per the study surgeon,
- Patient medically unfit to undergo surgery
- Patient refuses surgery
- Had not received prior radiotherapy to the proposed site of treatment.
- All patients having extremity STS with stages T2 and G2 or 3 with M0 (Stages IIB and III as per American Joint Committee on Cancer, AJCC 2010), would be included. For patients of STS of trunk, tumours less than 5cm may also be included if they are considered unresectable.
- Age more than 18 years
- Eastern Cooperative Oncology Group,ECOG performance scale 0 and 1
- Female patients must use effective contraception; must not be pregnant or lactating
- Life expectancy of atleast 2 years based on the age and co-morbidities, but excluding diagnosis of STS
- Absence of psychological, familial, sociological or geographical condition that could potentially hamper compliance with the study protocol and follow-up schedule
- Willing to travel to Paul Scherrer Institute for proton therapy and to Kantonsspital Aarau for Hyperthermia treatment.
- Agree to comply with the protocol
- Patients must sign a study specific informed consent form prior to registration.
Who cannot join
- Histopathology of rhabdomyosarcoma, extraosseous Ewing's, primary neuroectodermal tumour, aggressive fibromatosis (desmoids tumours), dermatofibrosarcoma protuberans, gastrointestinal stromal tumours, osteosarcoma, chondrosarcoma, Kaposi's sarcoma or angiosarcoma of scalp/face/neck
- Prior radiotherapy to the site of treatment
- Intrabdominal soft tissue sarcomas
- Use of neoadjuvant chemotherapy prior to radiotherapy or surgery
- Patients with regional nodal metastasis
- Patients with unequivocal distant metastasis
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- No prior or concurrent malignancies other than surgically treated squamous cell or basal cell carcinoma of the skin which are not in the area of the present malignancy or in situ carcinoma of the skin
- No serious medical illness which would prevent informed consent or limit survival to less than 2 years
- Active uncontrolled bacterial, viral or fungal infections until these conditions are corrected or controlled.
- Psychiatric or addictive disorders or other conditions that, in the opinion of the investigator would preclude the patient from meeting the study requirements.
- Patients having metal implants, pacemakers or clustered markers
- Patient who had a history of myocardial infarction within the past 12 months
- No connective disease disorders that contraindicate radiotherapy, e.g., Scleroderma
- -
Trial locations and contacts
1 site in 1 country.
Switzerland1 site, 1 recruiting
- Recruiting
Kantonsspital Aarau
Aarau, Canton of Aargau, CH 5001
Niloy R Datta, MD, DNB, CCST, 0041 62 8389559, niloyranjan.datta@ksa.ch
Emsad Puric, MD, 0041 92 85385, Emsad.Puric@ksa.ch
About this study
Official title: A Phase I/II Study of Concurrent Hyperthermia and Proton Beam Radiotherapy in Primary and Recurrent Unresectable Soft Tissue Sarcoma
This is a multi-institutional phase I/II clinical trial with concomitant local hyperthermia and proton beam radiotherapy in patients with primary or recurrent unresectable soft tissue sarcomas of the extremities, trunk, retroperitoneum (except intrabdominal). The primary purpose would be to assess the safety and efficacy of this approach along with local tumour regressions and subsequent tumour downstaging, thereby enabling a near total removal of these tumours following the hyperthermia and proton beam therapy.
Read the detailed description
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.
- Conditions
- Soft Tissue Sarcoma
- Being tested
- Hyperthermia and Proton Beam
- Keywords
- Hyperthermia,, Proton beam therapy, Soft Tissue Sarcoma, Radiotherapy, Phase I/II trial
- Medical subject headings
- Sarcoma, Hyperthermia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hyperthermia and Proton BeamRadiation
Also called 1. Local hyperthermia, 2. Proton beam therapy
- Local hyperthermia,once a week for 5 to 7 weeks to a temperature of 41.5 to 42.5 degree Centigrade
- Proton beam therapy, 5 days a week at 1.8 - 2.0 GyE per fraction to a dose of 55 - 60 GyE (preoperative) or 72 - 76 GyE (for radical. Patients who have good response at 5 weeks of treatment would be considered for preoperative treatment, while those with unsatisfactory response that could be taken up for at least R0 resection would be treated to a radical dose.
| Study group | Role | What they receive |
|---|---|---|
| Thermoradiotherapy | Experimental | Patients subjected to the planned therapeutic intervention of local hyperthermia and proton beam therapy Receives: Radiation: Hyperthermia and Proton Beam |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate safety of hyperthermia and proton beam treatment in unresectable soft tissue sarcomas
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
Measured: 6 months from end of treatment
Secondary outcomes (1)
To evaluate the local response to hyperthermia and proton beam therapy as a preoperative regimen for unresectable soft tissue sarcomaLocal control
Imaging response according to RECIST criteria comparing pretreatment MRI versus post treatment MRI taken 4 to 6 weeks after completion of the study treatment.
Measured: 6 months following the completion of study treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2013 (estimated)
- Study startFeb 2014
- Primary completionFeb 2018 (estimated)
- Study completionDec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Soft Tissue SarcomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 26 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kantonsspital Aarau
- Sponsor type
- University, hospital or other
- Collaborators
- Center for Proton Therapy, Paul Scherrer Institute, Villigen,Switzerland, University Hospital, Zürich
- Responsible party
- Principal investigator, Prof. Dr. med. Niloy Ranjan Datta, Kantonsspital Aarau
- Investigators
- Niloy R Datta, MD, DNB, Principal investigator, Kantonsspital Aarau, Switzerland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01904565
- Sponsor's protocol ID
- KSA_HYPROSAR1
- Acronym
- HYPROSAR
- Status last verified
- Aug 2015
- First submitted
- 10 Jul 2013
- Last updated
- 2 Sep 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Datta NR, Schneider R, Puric E, Ahlhelm FJ, Marder D, Bodis S, Weber DC. Proton Irradiation with Hyperthermia in Unresectable Soft Tissue Sarcoma. Int J Part Ther. 2016 Fall;3(2):327-336. doi: 10.14338/IJPT-16-00016.1. Epub 2016 Dec 30.
PubMed 31772984
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I/II Study of Concurrent Hyperthermia and Proton Beam Radiotherapy in Primary and Recurrent Unresectable Soft Tissue Sarcoma
- ClinicalTrials.gov ID
- NCT01904565
- Acronym / sponsor ID
- HYPROSAR / KSA_HYPROSAR1
- Conditions
- Soft Tissue Sarcoma
- Keywords
- Hyperthermia,, Proton beam therapy, Soft Tissue Sarcoma, Radiotherapy, Phase I/II trial
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 26 participants (estimated)
- Lead sponsor
- Kantonsspital AarauUniversity, hospital or other
- Collaborators
- Center for Proton Therapy, Paul Scherrer Institute, Villigen,Switzerland, University Hospital, Zürich
- Study start
- Feb 2014
- Primary completion
- Feb 2018 (estimated)
- Study completion
- Dec 2018 (estimated)
- First posted
- 22 Jul 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a multi-institutional phase I/II clinical trial with concomitant local hyperthermia and proton beam radiotherapy in patients with primary or recurrent unresectable soft tissue sarcomas of the extremities, trunk, retroperitoneum (except intrabdominal). The primary purpose would be to assess the safety and efficacy of this approach along with local tumour regressions and subsequent tumour downstaging, thereby enabling a near total removal of these tumours following the hyperthermia and proton beam therapy.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Thermoradiotherapy | Experimental | Radiation: Hyperthermia and Proton BeamPatients subjected to the planned therapeutic intervention of local hyperthermia and proton beam therapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (21 listed)
- Histopathologically proven and classified soft tissue sarcoma (STS) as per the WHO classification (2002). For all primary tumours, biopsy would be done within 2 months prior to registration and reviewed by the study pathologist. For all recurrent tumours, if prior biopsy has been done elsewhere, the histopathology would be reviewed by the study pathologist.
- Primary STS of extremities, trunk (except intrabdominal) and retroperitoneal which are,
- Recurrent STS extremities and trunk would be eligible if
- All patients having extremity STS with stages T2 and G2 or 3 with M0 (Stages IIB and III as per American Joint Committee on Cancer, AJCC 2010), would be included. For patients of STS of trunk, tumours less than 5cm may also be included if they are considered unresectable.
- Age more than 18 years
Key exclusion criteria (14 listed)
- Histopathology of rhabdomyosarcoma, extraosseous Ewing's, primary neuroectodermal tumour, aggressive fibromatosis (desmoids tumours), dermatofibrosarcoma protuberans, gastrointestinal stromal tumours, osteosarcoma, chondrosarcoma, Kaposi's sarcoma or angiosarcoma of scalp/face/neck
- Prior radiotherapy to the site of treatment
- Intrabdominal soft tissue sarcomas
- Use of neoadjuvant chemotherapy prior to radiotherapy or surgery
- Patients with regional nodal metastasis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hyperthermia and Proton BeamAlso: 1. Local hyperthermia, 2. Proton beam therapy1. Local hyperthermia,once a week for 5 to 7 weeks to a temperature of 41.5 to 42.5 degree Centigrade 2. Proton beam therapy, 5 days a week at 1.8 - 2.0 GyE per fraction to a dose of 55 - 60 GyE (preoperative) or 72 - 76 GyE (for radical. Patients who have good response at 5 weeks of treatment would be considered for preoperative treatment, while those with unsatisfactory response that could be taken up for at least R0 resection would be treated to a radical dose. | Radiation | Thermoradiotherapy |
Primary outcome
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
1 secondary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2015.
- Derived from this study: PubMed 31772984Datta NR, Schneider R, Puric E, Ahlhelm FJ, Marder D, Bodis S, Weber DC. Proton Irradiation with Hyperthermia in Unresectable Soft Tissue Sarcoma. Int J Part Ther. 2016 Fall;3(2):327-336. doi: 10.14338/IJPT-16-00016.1. Epub 2016 Dec 30.
- Kantonsspital AarauLink provided by the sponsor.
- Paul Scherrer InstituteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Niloy R Datta, MD, DNB principal investigator
Kantonsspital Aarau, Switzerland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Hyperthermia and Proton Beam in people with Soft Tissue Sarcoma, run by Kantonsspital Aarau at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 21 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Sep 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Niloy R Datta, MD, DNB, (+41-62 8389559, niloyranjan.datta@ksa.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To evaluate safety of hyperthermia and proton beam treatment in unresectable soft tissue sarcomas (time frame: 6 months from end of treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01904565, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Sep 2015; AzTrials last refreshed its copy on 31 Oct 2026.