Soft-Tissue SarcomaPhase 2NCT01389050
High Precision RT For Soft-Tissue Sarcoma
A Phase 2 study testing Intensity-Modulated Radiotherapy and Daily Cone Beam CT in people with Soft-Tissue Sarcoma, run by University Health Network, Toronto at 1 site in Canada.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Soft-Tissue Sarcoma
- What is being tested?
- Intensity-Modulated Radiotherapy and Daily Cone Beam CT
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteCanada
- Study dates
- 1 Jun 2011to 6 Jan 2022
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: Use of High Precision Radiotherapy in the Management of Soft-Tissue Sarcomas
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.
Read the 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.
- Conditions
- Soft-Tissue Sarcoma
- Being tested
- Intensity-Modulated Radiotherapy, Daily Cone Beam CT
- Medical subject headings
- Sarcoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intensity-Modulated RadiotherapyRadiation
Also called Pre-operative IMRT
Radiotherapy for the treatment of retroperitoneal sarcoma. IMRT will be 50.4 Gy given in 28 fractions.
Daily Cone Beam CTRadiation
Also called daily cone-beam Computed Tomography (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.
| Study group | Role | What they receive |
|---|---|---|
| Follow-up | No intervention | 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 | Not described Receives: Radiation: Intensity-Modulated Radiotherapy; Radiation: Daily Cone Beam CT |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 years
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.
Measured: 10 years
Secondary outcomes (2)
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.
Measured: 3 years
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.
Measured: 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2011 (estimated)
- Study start1 Jun 2011
- Primary completion6 Jan 2022
- Study completion6 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Soft-Tissue SarcomaStudies of the same condition, open and under way.
- More trials run by University Health Network, TorontoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Charles Catton, MD, Principal investigator, Princess Margaret Hospital, Canada
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01389050
- Sponsor's protocol ID
- UHN REB 10-0854-CE
- Status last verified
- Oct 2022
- First submitted
- 30 Jun 2011
- Last updated
- 7 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of High Precision Radiotherapy in the Management of Soft-Tissue Sarcomas
- ClinicalTrials.gov ID
- NCT01389050
- Acronym / sponsor ID
- UHN REB 10-0854-CE
- Conditions
- Soft-Tissue Sarcoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Study start
- 1 Jun 2011 (actual)
- Primary completion
- 6 Jan 2022 (actual)
- Study completion
- 6 Jan 2022 (actual)
- First posted
- 7 Jul 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Follow-up | No intervention | –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 | Radiation: Intensity-Modulated Radiotherapy, Radiation: Daily Cone Beam CT |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intensity-Modulated RadiotherapyAlso: Pre-operative IMRTRadiotherapy for the treatment of retroperitoneal sarcoma. IMRT will be 50.4 Gy given in 28 fractions. | Radiation | Prospective |
| Daily Cone Beam CTAlso: daily cone-beam Computed Tomography (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. | Radiation | Prospective |
Primary outcome
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.
2 secondary outcomes
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Oct 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Charles Catton, MD principal investigator
Princess Margaret Hospital, Canada
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Intensity-Modulated Radiotherapy and Daily Cone Beam CT in people with Soft-Tissue Sarcoma, run by University Health Network, Toronto at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To determine the extent of inter-fractional and intra-fractional movement of the GTV during radiotherapy treatments. (time frame: 3 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Oct 2022.