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Wide Excision of Soft Tissue Sarcomas in Combination With Interstitial Radiation Therapy

Primary Purpose

Sarcoma, Soft Tissue Sarcoma

Status

Recruiting

Phase

Not Applicable

Locations

Russian Federation

Study Type

Interventional

Intervention

Interstitial radiation therapy

Postoperative external beam therapy

About this trial

This is an interventional treatment trial for Sarcoma focused on measuring Sarcoma, Soft Tissue Sarcoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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
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

Sites / Locations

Federal State Budgetary Institution "N.N. Blokhin National Medical Research Center of Oncology" оf the Ministry of Health of the Russian FederationRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Interstitial radiation therapy

Postoperative external beam therapy, on the bed of the removed tumor

Arm Description

Duration: 11 days

Duration: 4 weeks

Outcomes

Primary Outcome Measures

disease-free survival

Time after treatment during which no sign of cancer is found

Secondary Outcome Measures

Comparison of hospitalization rate

Time after surgery till the end of hospitalization

Comparison of safety assessment

Adverse Event Assessment and Serious Adverse Event Assessment according to CTCAE 5.0

Comparison of performance status according Karnofsky scale

Improvement on the Karnofsky scale by 10-30 points

Comparison of pain relief according Visual Analogue Scale

Improvement on the Visual Analogue Scale by 3-5 points

Comparison of pain relief according Whatkins scale

Improvement on the Whatkins scale by 1-2 points

Full Information

NCT ID

NCT05057195

First Posted

September 7, 2021

Last Updated

March 1, 2022

Sponsor

Blokhin's Russian Cancer Research Center

1. Study Identification

Unique Protocol Identification Number

NCT05057195

Brief Title

Wide Excision of Soft Tissue Sarcomas in Combination With Interstitial Radiation Therapy

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2022

Overall Recruitment Status

Recruiting

Study Start Date

January 10, 2022 (Actual)

Primary Completion Date

December 2025 (Anticipated)

Study Completion Date

December 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Blokhin's Russian Cancer Research Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Sarcoma, Soft Tissue Sarcoma

Keywords

Sarcoma, Soft Tissue Sarcoma

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

78 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Interstitial radiation therapy

Arm Type

Experimental

Arm Description

Duration: 11 days

Arm Title

Postoperative external beam therapy, on the bed of the removed tumor

Arm Type

Active Comparator

Arm Description

Duration: 4 weeks

Intervention Type

Radiation

Intervention Name(s)

Interstitial radiation therapy

Intervention Description

From 30 to 50 Gy,

Intervention Type

Radiation

Intervention Name(s)

Postoperative external beam therapy

Intervention Description

50 Gy and locally on the tumor bed up to 10-26 Gy, depending on the status of the resection margin

Primary Outcome Measure Information:

Title

disease-free survival

Description

Time after treatment during which no sign of cancer is found

Time Frame

24 months

Secondary Outcome Measure Information:

Title

Comparison of hospitalization rate

Description

Time after surgery till the end of hospitalization

Time Frame

30 days

Title

Comparison of safety assessment

Description

Adverse Event Assessment and Serious Adverse Event Assessment according to CTCAE 5.0

Time Frame

24 months

Title

Comparison of performance status according Karnofsky scale

Description

Improvement on the Karnofsky scale by 10-30 points

Time Frame

24 months

Title

Comparison of pain relief according Visual Analogue Scale

Description

Improvement on the Visual Analogue Scale by 3-5 points

Time Frame

24 months

Title

Comparison of pain relief according Whatkins scale

Description

Improvement on the Whatkins scale by 1-2 points

Time Frame

24 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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 Exclusion Criteria: 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 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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Denis Burov, PhD

Phone

+79265585000

denisburov@yandex.ru

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Aslan Valiev, PhD

Organizational Affiliation

N.N. Blokhin NMRCO

Official's Role

Principal Investigator

Facility Information:

Facility Name

Federal State Budgetary Institution "N.N. Blokhin National Medical Research Center of Oncology" оf the Ministry of Health of the Russian Federation

City

Moscow

ZIP/Postal Code

115478

Country

Russian Federation

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Denis Burov, PhD

Phone

+79265585000

denisburov@yandex.ru

First Name & Middle Initial & Last Name & Degree

Aslan Valiev, PhD

First Name & Middle Initial & Last Name & Degree

Denis Burov, PhD

First Name & Middle Initial & Last Name & Degree

Beniamin Bokhyan, PhD

12. IPD Sharing Statement

Plan to Share IPD

Links:

URL

https://www.ronc.ru/about/struktura/niiko/ooo/hn1/

Description

official site

URL

https://sarcomarus.ru/

Description

russian surcoma group site

Learn more about this trial

Wide Excision of Soft Tissue Sarcomas in Combination With Interstitial Radiation Therapy

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