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High Precision RT For Soft-Tissue Sarcoma

Primary Purpose

Soft-Tissue Sarcoma

Status
Completed
Phase
Phase 2
Locations
Canada
Study Type
Interventional
Intervention
Intensity-Modulated Radiotherapy
Daily Cone Beam CT
Sponsored by
University Health Network, Toronto
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Soft-Tissue Sarcoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Pathologically (histologically or cytologically) proven diagnosis of sarcoma (except for GIST, Ewing's sarcoma and rhabdomyosarcoma) within the retroperitoneum. These include patients with locally recurrent disease
  • Planned to receive pre-operative radiotherapy
  • Will undergo a planning CT
  • Karnofsky Performance Status of ≥ 70 within 28 days prior to study entry
  • No systemic chemotherapy given prior to pre-operative radiotherapy
  • Able to provide written, informed consent
  • Women of childbearing potential and men who are sexually active must practice adequate contraception.

Exclusion Criteria:

  • Tumor pathology of GIST, Ewing's sarcoma or rhabdomyosarcoma
  • Metastatic disease to the retroperitoneum from a primary sarcoma not originating from the retroperitoneum
  • Systemic chemotherapy given prior to pre-operative radiotherapy.
  • Intent on giving chemotherapy ≤ 12 months from the completion of radiotherapy
  • Inability to undergo a 4D-CT simulation
  • KPS < 70
  • Unable to provide informed consent
  • Pregnant women

Sites / Locations

  • Princess Margaret Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Follow-up

Prospective

Arm Description

Data from these patients will be added to retrospectively gathered data from the PMH radiotherapy data bank (approximately 50 patients). The data collected will be analyzed using descriptive statistics.

Outcomes

Primary Outcome Measures

To determine the extent of inter-fractional and intra-fractional movement of the GTV during radiotherapy treatments.
To quantify and describe the movement of the tumor during and between radiotherapy treatments using imagings acquired during the course of radiotherapy planning and treatments.
To assess the acute and long-term toxicity of pre-operative radiotherapy as a function of the dose given to normal tissues and its impact on patient quality of life.
To describe the effect of radiotherapy to the patient by measuring the acute and long-term side-effects of radiation therapy.

Secondary Outcome Measures

Describe variations in the volume and shape of the GTV over the course of the treatment and need for adaptive therapy.
To measure and better define the response of the tumor to radiotherapy during treatments.
Correlate the pattern of local recurrence with the dose of radiation delivered accounting for motions and volume changes of target structures.
To determine whether there is a pattern of local relapse with the actual dose of radiation delivered to the tumor environment when tumor volumetric and positional changes are taken into account.

Full Information

First Posted
June 30, 2011
Last Updated
October 6, 2022
Sponsor
University Health Network, Toronto
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1. Study Identification

Unique Protocol Identification Number
NCT01389050
Brief Title
High Precision RT For Soft-Tissue Sarcoma
Official Title
Use of High Precision Radiotherapy in the Management of Soft-Tissue Sarcomas
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Completed
Study Start Date
June 1, 2011 (Actual)
Primary Completion Date
January 6, 2022 (Actual)
Study Completion Date
January 6, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Health Network, Toronto

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
This research study aims at defining 1) how retroperitoneal sarcomas change over the course of radiotherapy and 2) how radiotherapy affects your well-being. While the investigators know that radiotherapy before surgery is safe and effective, the amount of tumor motion and size change during radiotherapy is unknown. There is also very little information that describes the side-effects of radiotherapy in the treatment of this disease.
Detailed Description
Soft-tissue sarcomas (STS) that arise from the retroperitoneum are rare malignancies that are anatomical located deep within the abdominal area and thus pose challenges to surgical and radiotherapeutic management of the patient. As a result, the local control and overall survival for patients with retroperitoneal sarcomas (RPS) are worse than STS from the extremities. Current treatment strategy involves pre-operative radiotherapy followed by surgery. Use of intensity-modulated radiotherapy (IMRT) in RPS had allowed for more conformal treatments with the aim of sparing normal tissues from high doses of irradiation. Yet the accuracy and coverage of IMRT depend highly on target motion, and little is known about the motion of RPS during the course of radiotherapy. As well, RPS are commonly in close proximity to sensitive organs for which the long-term toxicity and effect on quality of life secondary to radiation is unknown. The current study seeks to evaluate the extent of tumor motion during radiotherapy and the impact of radiotherapy to patient toxicity and quality of life. At the conclusion of this study, our results will hopefully identify the optimum PTV, the importance of different normal tissues and their dose-volume constraints, the role of image guidance, and the potential for dose escalation in the treatment of RPS.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Soft-Tissue Sarcoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
26 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Follow-up
Arm Type
No Intervention
Arm Description
Data from these patients will be added to retrospectively gathered data from the PMH radiotherapy data bank (approximately 50 patients). The data collected will be analyzed using descriptive statistics.
Arm Title
Prospective
Arm Type
Experimental
Intervention Type
Radiation
Intervention Name(s)
Intensity-Modulated Radiotherapy
Other Intervention Name(s)
Pre-operative IMRT
Intervention Description
Radiotherapy for the treatment of retroperitoneal sarcoma. IMRT will be 50.4 Gy given in 28 fractions.
Intervention Type
Radiation
Intervention Name(s)
Daily Cone Beam CT
Other Intervention Name(s)
daily cone-beam Computed Tomography (CT)
Intervention Description
Images and information from the daily CT will be used for the repositioning of the patient prior to their treatments as per standard procedures.
Primary Outcome Measure Information:
Title
To determine the extent of inter-fractional and intra-fractional movement of the GTV during radiotherapy treatments.
Description
To quantify and describe the movement of the tumor during and between radiotherapy treatments using imagings acquired during the course of radiotherapy planning and treatments.
Time Frame
3 years
Title
To assess the acute and long-term toxicity of pre-operative radiotherapy as a function of the dose given to normal tissues and its impact on patient quality of life.
Description
To describe the effect of radiotherapy to the patient by measuring the acute and long-term side-effects of radiation therapy.
Time Frame
10 years
Secondary Outcome Measure Information:
Title
Describe variations in the volume and shape of the GTV over the course of the treatment and need for adaptive therapy.
Description
To measure and better define the response of the tumor to radiotherapy during treatments.
Time Frame
3 years
Title
Correlate the pattern of local recurrence with the dose of radiation delivered accounting for motions and volume changes of target structures.
Description
To determine whether there is a pattern of local relapse with the actual dose of radiation delivered to the tumor environment when tumor volumetric and positional changes are taken into account.
Time Frame
10 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Pathologically (histologically or cytologically) proven diagnosis of sarcoma (except for GIST, Ewing's sarcoma and rhabdomyosarcoma) within the retroperitoneum. These include patients with locally recurrent disease Planned to receive pre-operative radiotherapy Will undergo a planning CT Karnofsky Performance Status of ≥ 70 within 28 days prior to study entry No systemic chemotherapy given prior to pre-operative radiotherapy Able to provide written, informed consent Women of childbearing potential and men who are sexually active must practice adequate contraception. Exclusion Criteria: Tumor pathology of GIST, Ewing's sarcoma or rhabdomyosarcoma Metastatic disease to the retroperitoneum from a primary sarcoma not originating from the retroperitoneum Systemic chemotherapy given prior to pre-operative radiotherapy. Intent on giving chemotherapy ≤ 12 months from the completion of radiotherapy Inability to undergo a 4D-CT simulation KPS < 70 Unable to provide informed consent Pregnant women
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Charles Catton, MD
Organizational Affiliation
Princess Margaret Hospital, Canada
Official's Role
Principal Investigator
Facility Information:
Facility Name
Princess Margaret Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2M9
Country
Canada

12. IPD Sharing Statement

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High Precision RT For Soft-Tissue Sarcoma

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