High Precision RT For Soft-Tissue Sarcoma

Soft-Tissue Sarcoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01389050
• Other study ID #: UHN REB 10-0854-CE
• Status: Completed
• Phase: Phase 2
• Start date: June 1, 2011
• Est. completion date: January 6, 2022

Study information

• Verified date: October 2022
• Source: University Health Network, Toronto
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 26
• Est. completion date: January 6, 2022
• Est. primary completion date: January 6, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Sarcoma
• Soft-Tissue Sarcoma

Intervention

Radiation:
• Intensity-Modulated Radiotherapy
Radiotherapy for the treatment of retroperitoneal sarcoma. IMRT will be 50.4 Gy given in 28 fractions.
• 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.

Locations

Country	Name	City	State
Canada	Princess Margaret Hospital	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
University Health Network, Toronto

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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