NCT01904565

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
26

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Feb 2014

Longer than P75 for phase_1

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 10, 2013

Completed
12 days until next milestone

First Posted

Study publicly available on registry

July 22, 2013

Completed
6 months until next milestone

Study Start

First participant enrolled

February 1, 2014

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2018

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2018

Completed
Last Updated

September 2, 2015

Status Verified

August 1, 2015

Enrollment Period

4 years

First QC Date

July 10, 2013

Last Update Submit

August 31, 2015

Conditions

Soft Tissue Sarcoma

Keywords

Hyperthermia,Proton beam therapySoft Tissue SarcomaRadiotherapyPhase I/II trial

Outcome Measures

Primary Outcomes (1)

  • To evaluate safety of hyperthermia and proton beam treatment in unresectable soft tissue sarcomas

    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

    6 months from end of treatment

Secondary Outcomes (1)

  • 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

Other Outcomes (1)

  • Local disease free survival

    Would be assessed every 6 monthly up to a maximum of 48 months

Study Arms (1)

Thermoradiotherapy

EXPERIMENTAL

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

Radiation: Hyperthermia and Proton Beam

Interventions

Hyperthermia and Proton BeamRADIATION

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.

Also known as: 1. Local hyperthermia, 2. Proton beam therapy
Thermoradiotherapy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • Patient refuses surgery
  • Had not received prior radiotherapy to the proposed site of treatment.
  • 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.
  • Age more than 18 years
  • Eastern Cooperative Oncology Group,ECOG performance scale 0 and 1
  • +6 more criteria

You may not qualify if:

  • 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.
  • Patients having metal implants, pacemakers or clustered markers
  • Patient who had a history of myocardial infarction within the past 12 months
  • No connective disease disorders that contraindicate radiotherapy, e.g., Scleroderma

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kantonsspital Aarau

Aarau, Canton of Aargau, CH 5001, Switzerland

RECRUITING

Related Publications (1)

  • 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.

    PMID: 31772984DERIVED

Related Links

MeSH Terms

Conditions

SarcomaHyperthermia

Interventions

Diathermy

Condition Hierarchy (Ancestors)

Neoplasms, Connective and Soft TissueNeoplasms by Histologic TypeNeoplasmsBody Temperature ChangesSigns and SymptomsPathological Conditions, Signs and SymptomsHeat Stress DisordersWounds and Injuries

Intervention Hierarchy (Ancestors)

Hyperthermia, InducedTherapeutics

Study Officials

  • Niloy R Datta, MD, DNB

    Kantonsspital Aarau, Switzerland

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Niloy R Datta, MD, DNB,

CONTACT

+41-62 8389559niloyranjan.datta@ksa.ch

Stephan Bodis, MD

CONTACT

+41-62 838 5371stephan.bodis@ksa.ch

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Senior Consultant, Department of Radiation Oncology, KSA

Study Record Dates

First Submitted

July 10, 2013

First Posted

July 22, 2013

Study Start

February 1, 2014

Primary Completion

February 1, 2018

Study Completion

December 1, 2018

Last Updated

September 2, 2015

Record last verified: 2015-08

Locations

CH(1)