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Soft Tissue Sarcoma | Hyperthermia and Proton Therapy in Unresectable Soft Tissue Sarcoma

Soft Tissue Sarcoma research study

What is the primary objective of this study?

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.

Who is eligible to participate?

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

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Soft Tissue Sarcoma

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Radiation:Hyperthermia and Proton BeamLocal 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 Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

ThermoradiotherapyPatients subjected to the planned therapeutic intervention of local hyperthermia and proton beam therapy

Study Status

Recruiting

Start Date: February 2014

Completed Date: December 2018

Phase: Phase 1/Phase 2

Type: Interventional

Design:

Primary Outcome: To evaluate safety of hyperthermia and proton beam treatment in unresectable soft tissue sarcomas

Secondary Outcome: To evaluate the local response to hyperthermia and proton beam therapy as a preoperative regimen for unresectable soft tissue sarcomaLocal control

Study sponsors, principal investigator, and references

Principal Investigator: Niloy R Datta, MD, DNB

Lead Sponsor: Kantonsspital Aarau

Collaborator: Paul Scherrer Institute,Villigen,Switzerland

More information:https://clinicaltrials.gov/show/NCT01904565

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