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

Phase 2
18 Years
Open (Enrolling)
Soft-Tissue Sarcoma

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Trial Information

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

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.

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

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To determine the extent of inter-fractional and intra-fractional movement of the GTV during radiotherapy treatments.

Outcome 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.

Outcome Time Frame:

3 years

Safety Issue:


Principal Investigator

Charles Catton, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Princess Margaret Hospital, Canada


Canada: Ethics Review Committee

Study ID:

UHN REB 10-0854-CE



Start Date:

June 2011

Completion Date:

June 2021

Related Keywords:

  • Soft-Tissue Sarcoma
  • Sarcoma