SarcomaNCT05057195
Wide Excision of Soft Tissue Sarcomas in Combination With Interstitial Radiation Therapy
A study testing Interstitial radiation therapy and Postoperative external beam therapy in people with Sarcoma and Soft Tissue Sarcoma, run by Blokhin's Russian Cancer Research Center at 1 site in Russia.
Trial summary
Intraoperatively, in the bed of the removed tumor, a surgical mesh is sutured onto which the intrastats are fixed. On days 2-3, topometric preparation is carried out, the choice of the amount of irradiation, the calculation of the program. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sarcoma, Soft Tissue Sarcoma
- What is being tested?
- Interstitial radiation therapy and Postoperative external beam therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 78 participants
- Where
- 1 siteRussia
- Study dates
- 10 Jan 2022to Dec 2025
- Phase
- Interventional
- 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
- C49.1 Malignant neoplasm of the connective and soft tissues of the upper limb, including the shoulder girdle
- C49.2 Malignant neoplasm of the connective and soft tissues of the lower limb, including the hip region
- Tumor size 7 cm or less
- For malignant tumors: Grade 2-3
- Locally advanced soft tissue sarcomas
- Absence of regional metastases
- Tumor recurrence
Who cannot join
- Children, women during pregnancy, childbirth, women during breastfeeding.
- Military personnel, with the exception of contract military personnel.
- Persons with mental disorders.
- Persons detained, taken into custody, serving a sentence in the form of restriction of freedom, arrest, imprisonment or administrative arrest.
- The age of patients is under 18 years old
- Histologically confirmed diagnosis of GIST, Kaposi's sarcoma, alveolar, clear cell sarcoma, chondrosarcoma, paraossal osteosarcoma
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- Inoperable tumor
- A tumor with decay or with the threat of decay
- The presence of damage to the skin in the affected area
- The presence of a second malignant tumor
- Having an active or chronic fungal / bacterial / viral infection
- Uncontrolled chronic diseases of the liver, kidneys in the acute stage
- Superficial tumor (within the skin)
- The use of a reconstructive plastic component using a displaced musculocutaneous flap
- The use of vascular prosthetics
- The removed tumor bed is more than 7 cm
- The presence of a tumor growing into the bone
- The presence of blood vessels and nerves in the removed tumor bed
- Presence of metastases
- Surgical intervention using transplanted skin
Trial locations and contacts
1 site in 1 country.
Russia1 site, 1 recruiting
- Recruiting
Federal State Budgetary Institution "N.N. Blokhin National Medical Research Center of Oncology" оf the Ministry of Health of the Russian Federation
Moscow, 115478
Denis Burov, PhD, +79265585000, denisburov@yandex.ru
Aslan Valiev, PhD
About this study
Official title: Wide Excision of Soft Tissue Sarcomas in Combination With Interstitial Radiation Therapy in Patients With Soft Tissue Sarcomas of the Upper and Lower Extremities Compared With Postoperative Radiation Therapy
Intraoperatively, in the bed of the removed tumor, a surgical mesh is sutured onto which the intrastats are fixed. On days 2-3, topometric preparation is carried out, the choice of the amount of irradiation, the calculation of the program. On the 4-5th day after the operation, a course of intra-tissue radiation therapy begins in a single dose of 3 to 5 Gy in 10 fractions 2 times a day with an interval between fractions of 6 hours, the planned total dose is from 30 to 50 Gy. (from 40 to 70 IGy). Follow-up examination after 4 weeks and then every 3 months for 24 months
Read the detailed description
1 day before the operation, taking blood tests: general blood test with counting the leukocyte formula and the number of platelets; biochemical blood test with the determination of indicators of liver and kidney function (including electrolytes); coagulogram; performing surgical treatment with urgent histological examination of the edge of the tumor; intraoperatively, in the bed of the removed tumor, a surgical mesh is sutured onto which the intrastats are fixed with the fixation of the outlet ends on the skin with the help of buttons. 1 day after the operation, taking blood tests: a general blood test with the calculation of the leukocyte formula and the number of platelets; biochemical blood test with the determination of indicators of liver and kidney function (including electrolytes); coagulogram.
On the 2-3rd day after the surgical treatment, topometric preparation, the choice of the amount of radiation, and the calculation of the program are carried out. On the 4-5th day after the operation, a course of interstitial radiation therapy begins in a single dose of 3 to 5 Gy in 10 fractions 2 times a day with an interval between fractions of 6 hours, the planned total dose is from 30 to 50 Gy, which is equivalent to 40 to 70 IGy (isogrey). On the 6th day, removal of intrastats, on the 7th day after the operation, ultrasound of the wound and n / c vessels; assessment of the nature of wound healing. On the 10th day, discharge from the hospital.
- Conditions
- Sarcoma, Soft Tissue Sarcoma
- Being tested
- Interstitial radiation therapy, Postoperative external beam therapy
- Keywords
- Sarcoma, Soft Tissue Sarcoma
- Medical subject headings
- Sarcoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Interstitial radiation therapyRadiation
From 30 to 50 Gy,
Postoperative external beam therapyRadiation
50 Gy and locally on the tumor bed up to 10-26 Gy, depending on the status of the resection margin
| Study group | Role | What they receive |
|---|---|---|
| Interstitial radiation therapy | Experimental | Duration: 11 days Receives: Radiation: Interstitial radiation therapy |
| Postoperative external beam therapy, on the bed of the removed tumor | Active comparator | Duration: 4 weeks Receives: Radiation: Postoperative external beam therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
disease-free survival
Time after treatment during which no sign of cancer is found
Measured: 24 months
Secondary outcomes (5)
Comparison of hospitalization rate
Time after surgery till the end of hospitalization
Measured: 30 days
Comparison of safety assessment
Adverse Event Assessment and Serious Adverse Event Assessment according to CTCAE 5.0
Measured: 24 months
Comparison of performance status according Karnofsky scale
Improvement on the Karnofsky scale by 10-30 points
Measured: 24 months
Comparison of pain relief according Visual Analogue Scale
Improvement on the Visual Analogue Scale by 3-5 points
Measured: 24 months
Comparison of pain relief according Whatkins scale
Improvement on the Whatkins scale by 1-2 points
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2021
- Study start10 Jan 2022
- Primary completionDec 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SarcomaStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 78 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Blokhin's Russian Cancer Research Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Aslan Valiev, PhD, Principal investigator, N.N. Blokhin NMRCO
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05057195
- Sponsor's protocol ID
- SARCBT-2021-7-11
- Status last verified
- Mar 2024
- First submitted
- 7 Sep 2021
- Last updated
- 1 Apr 2024
- 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 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Wide Excision of Soft Tissue Sarcomas in Combination With Interstitial Radiation Therapy in Patients With Soft Tissue Sarcomas of the Upper and Lower Extremities Compared With Postoperative Radiation Therapy
- ClinicalTrials.gov ID
- NCT05057195
- Acronym / sponsor ID
- SARCBT-2021-7-11
- Conditions
- Sarcoma, Soft Tissue Sarcoma
- Keywords
- Sarcoma, Soft Tissue Sarcoma
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 78 participants (estimated)
- Lead sponsor
- Blokhin's Russian Cancer Research CenterUniversity, hospital or other
- Study start
- 10 Jan 2022 (actual)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 27 Sep 2021 (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.
Intraoperatively, in the bed of the removed tumor, a surgical mesh is sutured onto which the intrastats are fixed. On days 2-3, topometric preparation is carried out, the choice of the amount of irradiation, the calculation of the program. On the 4-5th day after the operation, a course of intra-tissue radiation therapy begins in a single dose of 3 to 5 Gy in 10 fractions 2 times a day with an interval between fractions of 6 hours, the planned total dose is from 30 to 50 Gy. (from 40 to 70 IGy). Follow-up examination after 4 weeks and then every 3 months for 24 months
Detailed description
1 day before the operation, taking blood tests: general blood test with counting the leukocyte formula and the number of platelets; biochemical blood test with the determination of indicators of liver and kidney function (including electrolytes); coagulogram; performing surgical treatment with urgent histological examination of the edge of the tumor; intraoperatively, in the bed of the removed tumor, a surgical mesh is sutured onto which the intrastats are fixed with the fixation of the outlet ends on the skin with the help of buttons. 1 day after the operation, taking blood tests: a general blood test with the calculation of the leukocyte formula and the number of platelets; biochemical blood test with the determination of indicators of liver and kidney function (including electrolytes); coagulogram.
On the 2-3rd day after the surgical treatment, topometric preparation, the choice of the amount of radiation, and the calculation of the program are carried out. On the 4-5th day after the operation, a course of interstitial radiation therapy begins in a single dose of 3 to 5 Gy in 10 fractions 2 times a day with an interval between fractions of 6 hours, the planned total dose is from 30 to 50 Gy, which is equivalent to 40 to 70 IGy (isogrey). On the 6th day, removal of intrastats, on the 7th day after the operation, ultrasound of the wound and n / c vessels; assessment of the nature of wound healing. On the 10th day, discharge from the hospital.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Interstitial radiation therapy | Experimental | Radiation: Interstitial radiation therapyDuration: 11 days |
| Postoperative external beam therapy, on the bed of the removed tumor | Active comparator | Radiation: Postoperative external beam therapyDuration: 4 weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- C49.1 Malignant neoplasm of the connective and soft tissues of the upper limb, including the shoulder girdle
- C49.2 Malignant neoplasm of the connective and soft tissues of the lower limb, including the hip region
- Tumor size 7 cm or less
- For malignant tumors: Grade 2-3
- Locally advanced soft tissue sarcomas
Key exclusion criteria (20 listed)
- Children, women during pregnancy, childbirth, women during breastfeeding.
- Military personnel, with the exception of contract military personnel.
- Persons with mental disorders.
- Persons detained, taken into custody, serving a sentence in the form of restriction of freedom, arrest, imprisonment or administrative arrest.
- The age of patients is under 18 years old
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 |
|---|---|---|
| Interstitial radiation therapyFrom 30 to 50 Gy, | Radiation | Interstitial radiation therapy |
| Postoperative external beam therapy50 Gy and locally on the tumor bed up to 10-26 Gy, depending on the status of the resection margin | Radiation | Postoperative external beam therapy, on the bed of the removed tumor |
Primary outcome
disease-free survival
Time frame: 24 months
Time after treatment during which no sign of cancer is found
5 secondary outcomes
Comparison of hospitalization rate
Time frame: 30 days
Comparison of safety assessment
Time frame: 24 months
Comparison of performance status according Karnofsky scale
Time frame: 24 months
Comparison of pain relief according Visual Analogue Scale
Time frame: 24 months
Comparison of pain relief according Whatkins scale
Time frame: 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2024.
- official siteLink provided by the sponsor.
- russian surcoma group siteLink provided by the sponsor.
- 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. This study is not recruiting at the moment.
Aslan Valiev, PhD principal investigator
N.N. Blokhin NMRCO
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Interstitial radiation therapy and Postoperative external beam therapy in people with Sarcoma and Soft Tissue Sarcoma, run by Blokhin's Russian Cancer Research Center 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 7 inclusion and 20 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: status not confirmed, as of the sponsor's last update on 1 Apr 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Denis Burov, PhD (+79265585000, denisburov@yandex.ru), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
disease-free survival (time frame: 24 months). 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 2024.