Hyperthermia and Proton Therapy in Unresectable Soft Tissue Sarcoma (HYPROSAR)

This is an interventional treatment trial for Soft Tissue Sarcoma focused on measuring Hyperthermia,, Proton beam therapy, Soft Tissue Sarcoma, Radiotherapy, Phase I/II trial Read More

Inclusion Criteria:

1. 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.

2. Primary STS of extremities, trunk (except intrabdominal) and retroperitoneal which are,

   1. Deemed inoperable by the study surgeon
   2. Not feasible for a limb sparing surgery with possible R0/R1 resection as per the study surgeon,
   3. Patient medically unfit to undergo surgery
   4. Patient refuses surgery

3. Recurrent STS extremities and trunk would be eligible if

   1. Deemed inoperable by the study surgeon
   2. Not feasible for a limb sparing surgery with possible R0/R1 resection as per the study surgeon,
   3. Patient medically unfit to undergo surgery
   4. Patient refuses surgery
   5. Had not received prior radiotherapy to the proposed site of treatment.
4. 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.
5. Age more than 18 years
6. Eastern Cooperative Oncology Group,ECOG performance scale 0 and 1
7. Female patients must use effective contraception; must not be pregnant or lactating
8. Life expectancy of atleast 2 years based on the age and co-morbidities, but excluding diagnosis of STS
9. Absence of psychological, familial, sociological or geographical condition that could potentially hamper compliance with the study protocol and follow-up schedule
10. Willing to travel to Paul Scherrer Institute for proton therapy and to Kantonsspital Aarau for Hyperthermia treatment.
11. Agree to comply with the protocol
12. Patients must sign a study specific informed consent form prior to registration.

Exclusion Criteria:

1. 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
2. Prior radiotherapy to the site of treatment
3. Intrabdominal soft tissue sarcomas
4. Use of neoadjuvant chemotherapy prior to radiotherapy or surgery
5. Patients with regional nodal metastasis
6. Patients with unequivocal distant metastasis
7. 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
8. No serious medical illness which would prevent informed consent or limit survival to less than 2 years
9. Active uncontrolled bacterial, viral or fungal infections until these conditions are corrected or controlled.
10. Psychiatric or addictive disorders or other conditions that, in the opinion of the investigator would preclude the patient from meeting the study requirements.
11. Patients having metal implants, pacemakers or clustered markers
12. Patient who had a history of myocardial infarction within the past 12 months

13. No connective disease disorders that contraindicate radiotherapy, e.g., Scleroderma

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