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Hyperthermia and Proton Therapy in Unresectable Soft Tissue Sarcoma

NCT01904565 · Status: UNKNOWN · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 26

Last updated 2015-09-02

No results posted yet for this study

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.

Conditions

  • Soft Tissue Sarcoma

Interventions

RADIATION

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.

Sponsors & Collaborators

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

    collaborator OTHER

  • University Hospital, Zürich

    collaborator OTHER

  • Kantonsspital Aarau

    lead OTHER

Principal Investigators

  • Niloy R Datta, MD, DNB · Kantonsspital Aarau, Switzerland

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-02-28
Primary Completion
2018-02-28
Completion
2018-12-31

Countries

  • Switzerland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01904565 on ClinicalTrials.gov