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
|Condition or disease||Intervention/treatment||Phase|
|Soft-Tissue Sarcoma||Radiation: Intensity-Modulated Radiotherapy Radiation: Daily Cone Beam CT||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||70 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
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.
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 IMRTRadiation: 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)
- 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.
- 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.
- 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.
- 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.
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
|Princess Margaret Hospital|
|Toronto, Ontario, Canada, M5G 2M9|
|Principal Investigator:||Charles Catton, MD||Princess Margaret Hospital, Canada|