Hyperthermia and Proton Therapy in Unresectable Soft Tissue Sarcoma

NCT ID: NCT01904565

Last Updated: 2015-09-02

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 26 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-02-28
• Study Completion Date: 2018-12-31

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.

Conditions

Soft Tissue Sarcoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Thermoradiotherapy

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

Group Type: EXPERIMENTAL

Hyperthermia and Proton Beam

Intervention Type: RADIATION

1. 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.

Interventions

Hyperthermia and Proton Beam

1. 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.

Intervention Type: RADIATION

Other Intervention Names

1. Local hyperthermia; 2. Proton beam therapy

Eligibility Criteria

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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• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Center for Proton Therapy, Paul Scherrer Institute, Villigen,Switzerland

OTHER

Sponsor Role: collaborator

University Hospital, Zürich

OTHER

Sponsor Role: collaborator

Kantonsspital Aarau

OTHER

Sponsor Role: lead

Responsible Party

Prof. Dr. med. Niloy Ranjan Datta

Senior Consultant, Department of Radiation Oncology, KSA

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Niloy R Datta, MD, DNB

Role: PRINCIPAL_INVESTIGATOR

Kantonsspital Aarau, Switzerland

Locations

Kantonsspital Aarau

Aarau, Canton of Aargau, Switzerland

Site Status: RECRUITING

Countries

Switzerland

Central Contacts

Niloy R Datta, MD, DNB,

Role: CONTACT

niloyranjan.datta@ksa.ch

+41-62 8389559

Stephan Bodis, MD

Role: CONTACT

stephan.bodis@ksa.ch

+41-62 838 5371

Facility Contacts

Niloy R Datta, MD, DNB, CCST

Role: primary

niloyranjan.datta@ksa.ch

0041 62 8389559

Emsad Puric, MD

Role: backup

Emsad.Puric@ksa.ch

0041 92 85385

References

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.

Reference Type: DERIVED

PMID: 31772984 (View on PubMed)

Related Links

http://www.ksa.ch

Kantonsspital Aarau

http://www.psi.ch

Paul Scherrer Institute

Other Identifiers

KSA_HYPROSAR1

Identifier Type: -

Identifier Source: org_study_id