Soft Tissue Sarcoma AdultNCT04330456
Combined Treatment of Patients With Soft Tissue Sarcoma Including Preoperative Stereotactic Radiation Therapy and Postoperative Conformal Radiation Therapy
A study testing Preoperative stereotactic radiation therapy in hypofractionation mode, Surgery and Postoperative conformal radiation therapy in normofractionation mode in people with Soft Tissue Sarcoma Adult, run by N.N. Petrov National Medical Research Center of Oncology at 1 site in Russia.
Trial summary
Combined treatment of soft tissue sarcoma includes 3 steps: 1. step - preoperative stereotactic radiation therapy in hypofractionation mode 2. step - operation 3. step - postoperative conformal radiation therapy in normofractionation mode Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Soft Tissue Sarcoma Adult
- What is being tested?
- Preoperative stereotactic radiation therapy in hypofractionation mode, Surgery and Postoperative conformal radiation therapy in normofractionation mode
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteRussia
- Study dates
- 1 Feb 2020to 1 Jul 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- morphologically verified diagnosis of soft tissue sarcoma
- first diagnosed tumor process
- ability to perform radical surgery
- signed informed consent
- indications for stereotactic and conformal radiation therapy
- no contraindications for radiation and surgical treatment
Who cannot join
- previous radiation treatment
- acute infection
- pregnancy, lactation
- recurrent tumor
- refuse to sign informed consent
- conditions that can affect the outcome of treatment (immunodeficiency, tuberculosis, etc.)
- tumor topography and volume that don't allow to perform stereotactic and conformal radiation therapy.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Russia1 site, 1 recruiting
- Recruiting
National Research Center of Oncology named after N.N.Petrov
Saint Petersburg
Grigory Zinovev, PhD, +79213405814, zinovevgrigory@gmail.com
About this study
Combined treatment of soft tissue sarcoma includes 3 steps:
- step - preoperative stereotactic radiation therapy in hypofractionation mode
- step - operation
- step - postoperative conformal radiation therapy in normofractionation mode
Read the detailed description
Combined treatment of soft tissue sarcoma includes 3 steps:
- At the first step patient undergoes preoperative stereotactic radiation therapy in hypofractionation mode. Radiation therapy plan is based on topometric MRI and CT scans. Radiation therapy plan are performed after MRI and CT fusion, contouring of the target and surrounding normal tissues. At first step only tumor and, if necessary, the surrounding normal tissues, which will be removed during surgery, are exposed to radiation. GTV - determined in with the boundaries of the tumor visualised by topometric MRI and CT CTV1 - match GTV CTV2 - formed inward (to the tumor center) from GTV by 0.5-1 cm (depending on the proximity of functionally significant normal tissues (neurovascular bundles, bone tissue, skin and subcutaneous fat, etc.) PTV - 3-5 mm indent from CTV1, taking into account the proximity of functionally significant normal tissues and the planned surgery Preoperative radiation therapy is carried in 5 fractions with a single dose on PTV - 5 Gy, a single dose on CTV2 - 7 Gy.
- Second step is surgery in 14-21 days.
- In 25-35 days after the surgery postoperative conformal radiation therapy is performed according to the standard protocol GTV (tumor bed) - based on the volume of the primary tumor, including the swelling zone (T2-weighted images on preoperative MRI) СTV - formed with an indent of 4 cm from GTV (without going beyond the boundaries of the involved compartment), in the transverse direction the indent could be reduced to 2 cm.
PTV - formed with an indent of 0.5-1cm from CTV An important condition for planning radiation therapy is to limit the dose absorbed during both stages of radiation therapy in surrounding normal tissues that are not removed during surgery.
- Conditions
- Soft Tissue Sarcoma Adult
- Being tested
- Preoperative stereotactic radiation therapy in hypofractionation mode, Surgery, Postoperative conformal radiation therapy in normofractionation mode
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Preoperative stereotactic radiation therapy in hypofractionation modeRadiation
At the first step patient undergoes preoperative stereotactic radiation therapy in hypofractionation mode. Radiation therapy plan is based on topometric MRI and CT scans. Radiation therapy plan are performed after MRI and CT fusion, contouring of the target and surrounding normal tissues.
At first step only tumor and, if necessary, the surrounding normal tissues, which will be removed during surgery, are exposed to radiation.
GTV - determined in with the boundaries of the tumor visualised by topometric MRI and CT CTV1 - match GTV CTV2 - formed inward (to the tumor center) from GTV by 0.5-1 cm (depending on the proximity of functionally significant normal tissues (neurovascular bundles, bone tissue, skin and subcutaneous fat, etc.) PTV - 3-5 mm indent from CTV1, taking into account the proximity of functionally significant normal tissues and the planned surgery Preoperative radiation therapy is carried in 5 fractions with a single dose on PTV - 5 Gy, a single dose on CTV2 - 7 Gy.
SurgeryProcedure or surgery
In 14-21 days after preoperative stereotactic radiation therapy radical surgery will be performed
Postoperative conformal radiation therapy in normofractionation modeRadiation
In 25-35 days after the surgery postoperative conformal radiation therapy is performed according to the standard protocol GTV (tumor bed) - based on the volume of the primary tumor, including the swelling zone (T2-weighted images on preoperative MRI) СTV - formed with an indent of 4 cm from GTV (without going beyond the boundaries of the involved compartment), in the transverse direction the indent could be reduced to 2 cm.
PTV - formed with an indent of 0.5-1cm from CTV An important condition for planning radiation therapy is to limit the dose absorbed during both stages of radiation therapy in surrounding normal tissues that are not removed during surgery.
| Study group | Role | What they receive |
|---|---|---|
| SaE treatment | Experimental | This group will receive combined treatment of soft tissue sarcoma that include 3 steps:
1. step - preoperative stereotactic radiation therapy in hypofractionation mode (5 fractions 5 Gy each)
2. step - operation
3. step - postoperative conformal radiation therapy in normofractionation mode (25 fractions 2 Gy each) Receives: Radiation: Preoperative stereotactic radiation therapy in hypofractionation mode; Procedure: Surgery; Radiation: Postoperative conformal radiation therapy in normofractionation mode |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complications
Rate of complications will be measured after completing each step of protocol: stereotactic radiation therapy, surgery and them postoperative conformal radiation therapy
Measured: 3 year
Secondary outcomes (1)
Disease-Free survival
Disease-Free survival will be evaluated after completing the protocol or during the protocol if local recurrence will appear.
Measured: 3 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2020
- Study start1 Feb 2020
- Primary completion1 Jul 2022 (estimated)
- Study completion1 Jul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Soft Tissue Sarcoma AdultStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- N.N. Petrov National Medical Research Center of Oncology
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04330456
- Sponsor's protocol ID
- SaE in STS
- Status last verified
- Feb 2020
- First submitted
- 26 Mar 2020
- Last updated
- 1 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Combined Treatment of Patients With Soft Tissue Sarcoma Including Preoperative Stereotactic Radiation Therapy and Postoperative Conformal Radiation Therapy
- ClinicalTrials.gov ID
- NCT04330456
- Acronym / sponsor ID
- SaE in STS
- Conditions
- Soft Tissue Sarcoma Adult
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- N.N. Petrov National Medical Research Center of OncologyUniversity, hospital or other
- Study start
- 1 Feb 2020 (actual)
- Primary completion
- 1 Jul 2022 (estimated)
- Study completion
- 1 Jul 2028 (estimated)
- First posted
- 1 Apr 2020 (actual)
- 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.
Combined treatment of soft tissue sarcoma includes 3 steps:
- step - preoperative stereotactic radiation therapy in hypofractionation mode
- step - operation
- step - postoperative conformal radiation therapy in normofractionation mode
Detailed description
Combined treatment of soft tissue sarcoma includes 3 steps:
- At the first step patient undergoes preoperative stereotactic radiation therapy in hypofractionation mode. Radiation therapy plan is based on topometric MRI and CT scans. Radiation therapy plan are performed after MRI and CT fusion, contouring of the target and surrounding normal tissues. At first step only tumor and, if necessary, the surrounding normal tissues, which will be removed during surgery, are exposed to radiation. GTV - determined in with the boundaries of the tumor visualised by topometric MRI and CT CTV1 - match GTV CTV2 - formed inward (to the tumor center) from GTV by 0.5-1 cm (depending on the proximity of functionally significant normal tissues (neurovascular bundles, bone tissue, skin and subcutaneous fat, etc.) PTV - 3-5 mm indent from CTV1, taking into account the proximity of functionally significant normal tissues and the planned surgery Preoperative radiation therapy is carried in 5 fractions with a single dose on PTV - 5 Gy, a single dose on CTV2 - 7 Gy.
- Second step is surgery in 14-21 days.
- In 25-35 days after the surgery postoperative conformal radiation therapy is performed according to the standard protocol GTV (tumor bed) - based on the volume of the primary tumor, including the swelling zone (T2-weighted images on preoperative MRI) СTV - formed with an indent of 4 cm from GTV (without going beyond the boundaries of the involved compartment), in the transverse direction the indent could be reduced to 2 cm.
PTV - formed with an indent of 0.5-1cm from CTV An important condition for planning radiation therapy is to limit the dose absorbed during both stages of radiation therapy in surrounding normal tissues that are not removed during surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SaE treatment | Experimental | Radiation: Preoperative stereotactic radiation therapy in hypofractionation mode, Procedure: Surgery, Radiation: Postoperative conformal radiation therapy in normofractionation modeThis group will receive combined treatment of soft tissue sarcoma that include 3 steps: 1. step - preoperative stereotactic radiation therapy in hypofractionation mode (5 fractions 5 Gy each) 2. step - operation 3. step - postoperative conformal radiation therapy in normofractionation mode (25 fractions 2 Gy each) |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- morphologically verified diagnosis of soft tissue sarcoma
- first diagnosed tumor process
- ability to perform radical surgery
- signed informed consent
- indications for stereotactic and conformal radiation therapy
Key exclusion criteria (7 listed)
- previous radiation treatment
- acute infection
- pregnancy, lactation
- recurrent tumor
- refuse to sign informed consent
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 |
|---|---|---|
| Preoperative stereotactic radiation therapy in hypofractionation modeAt the first step patient undergoes preoperative stereotactic radiation therapy in hypofractionation mode. Radiation therapy plan is based on topometric MRI and CT scans. Radiation therapy plan are performed after MRI and CT fusion, contouring of the target and surrounding normal tissues. At first step only tumor and, if necessary, the surrounding normal tissues, which will be removed during surgery, are exposed to radiation. GTV - determined in with the boundaries of the tumor visualised by topometric MRI and CT CTV1 - match GTV CTV2 - formed inward (to the tumor center) from GTV by 0.5-1 cm (depending on the proximity of functionally significant normal tissues (neurovascular bundles, bone tissue, skin and subcutaneous fat, etc.) PTV - 3-5 mm indent from CTV1, taking into account the proximity of functionally significant normal tissues and the planned surgery Preoperative radiation therapy is carried in 5 fractions with a single dose on PTV - 5 Gy, a single dose on CTV2 - 7 Gy. | Radiation | SaE treatment |
| SurgeryIn 14-21 days after preoperative stereotactic radiation therapy radical surgery will be performed | Procedure or surgery | SaE treatment |
| Postoperative conformal radiation therapy in normofractionation modeIn 25-35 days after the surgery postoperative conformal radiation therapy is performed according to the standard protocol GTV (tumor bed) - based on the volume of the primary tumor, including the swelling zone (T2-weighted images on preoperative MRI) СTV - formed with an indent of 4 cm from GTV (without going beyond the boundaries of the involved compartment), in the transverse direction the indent could be reduced to 2 cm. PTV - formed with an indent of 0.5-1cm from CTV An important condition for planning radiation therapy is to limit the dose absorbed during both stages of radiation therapy in surrounding normal tissues that are not removed during surgery. | Radiation | SaE treatment |
Primary outcome
Complications
Time frame: 3 year
Rate of complications will be measured after completing each step of protocol: stereotactic radiation therapy, surgery and them postoperative conformal radiation therapy
1 secondary outcome
Disease-Free survival
Time frame: 3 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2020.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Preoperative stereotactic radiation therapy in hypofractionation mode, Surgery and Postoperative conformal radiation therapy in normofractionation mode in people with Soft Tissue Sarcoma Adult, run by N.N. Petrov National Medical Research Center of Oncology at 1 site in Russia.
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 6 inclusion and 7 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: looking for participants now, as of the sponsor's last update on 1 Apr 2020. 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 Russia. 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.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Grigory Zinovev, PhD (+79213405814, zinovevgrigory@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Complications (time frame: 3 year). 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 1 Apr 2020.