Clinical trial NCT01389050: High Precision RT For Soft-Tissue Sarcoma
Official title: Use of High Precision Radiotherapy in the Management of Soft-Tissue Sarcomas
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Soft-Tissue Sarcoma
Lead sponsor: University Health Network, Toronto
Sponsor class: OTHER
First posted: 2011-07-07
Enrollment: 26
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: To determine the extent of inter-fractional and intra-fractional movement of the GTV during radiotherapy treatments.
timeFrame: 3 years
measure: 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.
timeFrame: 10 years
Secondary outcomes:
measure: Describe variations in the volume and shape of the GTV over the course of the treatment and need for adaptive therapy.
timeFrame: 3 years
measure: Correlate the pattern of local recurrence with the dose of radiation delivered accounting for motions and volume changes of target structures.
timeFrame: 10 years
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Princess Margaret Hospital
state: Ontario
Study officials:
affiliation: Princess Margaret Hospital, Canada
name: Charles Catton, MD
role: PRINCIPAL_INVESTIGATOR
References: