High Precision RT For Soft-Tissue Sarcoma

University Health Network, Toronto

Status and phase: Completed; Phase 2

Conditions: Soft-Tissue Sarcoma

Treatments: Radiation: Intensity-Modulated Radiotherapy; Radiation: Daily Cone Beam CT

Study type: Interventional

Funder types: Other

Identifiers

NCT01389050

UHN REB 10-0854-CE

Details and patient eligibility

About

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.

Full 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.

Enrollment: 26 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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26 participants in 2 patient groups

Follow-up

No Intervention group

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.

Prospective

Experimental group

Treatment:

Radiation: Daily Cone Beam CT

Radiation: Intensity-Modulated Radiotherapy