High Precision RT For Soft-Tissue Sarcoma

Use of High Precision Radiotherapy in the Management of Soft-Tissue Sarcomas

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.

Study Overview

• Status: Completed
• Conditions: Soft-Tissue Sarcoma
• Intervention / Treatment: Radiation: Intensity-Modulated Radiotherapy; Radiation: Daily Cone Beam CT

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.

• Study Type: Interventional
• Enrollment (Actual): 26
• Phase: Phase 2

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada, M5G 2M9
      • Princess Margaret Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Follow-up; 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.
Experimental: Prospective	Radiation: Intensity-Modulated Radiotherapy; Radiotherapy for the treatment of retroperitoneal sarcoma. IMRT will be 50.4 Gy given in 28 fractions.; Other Names: Pre-operative IMRT; Radiation: Daily Cone Beam CT; Images and information from the daily CT will be used for the repositioning of the patient prior to their treatments as per standard procedures.; Other Names: daily cone-beam Computed Tomography (CT)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	3 years
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.	10 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	3 years
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.	10 years

Collaborators and Investigators

• Sponsor: University Health Network, Toronto
• Investigators: Principal Investigator: Charles Catton, MD, Princess Margaret Hospital, Canada

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2011
• Primary Completion (Actual): January 6, 2022
• Study Completion (Actual): January 6, 2022

Study Registration Dates

• First Submitted: June 30, 2011
• First Submitted That Met QC Criteria: July 5, 2011
• First Posted (Estimate): July 7, 2011

Study Record Updates

• Last Update Posted (Actual): October 7, 2022
• Last Update Submitted That Met QC Criteria: October 6, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Sarcoma
• Other Study ID Numbers: UHN REB 10-0854-CE