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High Precision RT For Soft-Tissue Sarcoma

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ClinicalTrials.gov Identifier: NCT01389050
Recruitment Status : Active, not recruiting
First Posted : July 7, 2011
Last Update Posted : January 24, 2018
Sponsor:
Information provided by (Responsible Party):
University Health Network, Toronto

Study Description
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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.

Condition or disease Intervention/treatment Phase
Soft-Tissue Sarcoma Radiation: Intensity-Modulated Radiotherapy Radiation: Daily Cone Beam CT Phase 2

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 70 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Use of High Precision Radiotherapy in the Management of Soft-Tissue Sarcomas
Study Start Date : June 2011
Estimated Primary Completion Date : June 2021
Estimated Study Completion Date : June 2021

Resource links provided by the National Library of Medicine


Arms and Interventions
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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 Name: 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 Name: daily cone-beam Computed Tomography (CT)


Outcome Measures
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Primary Outcome Measures :
  1. To determine the extent of inter-fractional and intra-fractional movement of the GTV during radiotherapy treatments. [ Time Frame: 3 years ]
    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.

  2. 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. [ Time Frame: 10 years ]
    To describe the effect of radiotherapy to the patient by measuring the acute and long-term side-effects of radiation therapy.


Secondary Outcome Measures :
  1. Describe variations in the volume and shape of the GTV over the course of the treatment and need for adaptive therapy. [ Time Frame: 3 years ]
    To measure and better define the response of the tumor to radiotherapy during treatments.

  2. Correlate the pattern of local recurrence with the dose of radiation delivered accounting for motions and volume changes of target structures. [ Time Frame: 10 years ]
    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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01389050


Locations
Canada, Ontario
Princess Margaret Hospital
Toronto, Ontario, Canada, M5G 2M9
Sponsors and Collaborators
University Health Network, Toronto
Investigators
Principal Investigator: Charles Catton, MD Princess Margaret Hospital, Canada
More Information
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Responsible Party: University Health Network, Toronto
ClinicalTrials.gov Identifier: NCT01389050     History of Changes
Other Study ID Numbers: UHN REB 10-0854-CE
First Posted: July 7, 2011    Key Record Dates
Last Update Posted: January 24, 2018
Last Verified: January 2018

Additional relevant MeSH terms:
Sarcoma
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms