A Phase I/II Study of Concurrent Hyperthermia and Proton Beam Radiotherapy in Primary and Recurrent Unresectable Soft Tissue Sarcoma
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Soft Tissue Sarcoma
- Sponsor
- Kantonsspital Aarau
- Enrollment
- 26
- Locations
- 1
- Primary Endpoint
- To evaluate safety of hyperthermia and proton beam treatment in unresectable soft tissue sarcomas
- Last Updated
- 10 years ago
Overview
Brief 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). 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.
Investigators
Prof. Dr. med. Niloy Ranjan Datta
Senior Consultant, Department of Radiation Oncology, KSA
Kantonsspital Aarau
Eligibility Criteria
Inclusion Criteria
- •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
- •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
Exclusion Criteria
- •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
- •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.
Outcomes
Primary Outcomes
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
Secondary Outcomes
- To evaluate the local response to hyperthermia and proton beam therapy as a preoperative regimen for unresectable soft tissue sarcomaLocal control(6 months following the completion of study treatment)