Oligometastatic DiseasePhase 2/3NCT06556550
Stereotactic Radiotherapy for Oligometastasis (1-5) in Various Tumor Sites vs. Palliative Care
A Phase 2/3 study testing stereotactic ablative radiation therapy, palliative radiation therapy and Chemotherapy in people with Oligometastatic Disease, run by National Medical Research Radiological Centre of the Ministry of Health of Russia at 1 site in Russia.
Trial summary
Currently, the usual standard of palliative treatment used in patients with diagnosed oligometastatic cancer in accordance with the local clinical recommendations is chemotherapy and/or a symptomatic course of radiation therapy in doses less than ablative ones The aim of the study is to increase the effectiveness of… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Oligometastatic Disease
- What is being tested?
- stereotactic ablative radiation therapy, palliative radiation therapy and Chemotherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteRussia
- Study dates
- 31 May 2024to 31 Dec 2029
- Phase
- Phase 2/3
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically confirmed malignant formation (ICD 10-11 codes С18, С19, С20, С34, С50, С61, С64).
- 0-2 points on the WHO/ECOG scale of assessment of the general condition of the patient.
- The absence of disease progression after the current line of chemotherapeutic treatment.
- The number of oligometastases is not more than 3 in one organ, in the presence of a multi-organ lesion.
- The total number of distant metastases is no more than 5.
- Life expectancy of more than 6 months for brain metastases (GPA-score)
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- The possibility of SBRT for all distant metastases, in accordance with the criteria specified in the study design.
- Making decisions on the inclusion of a patient in the study protocol based on the results of an interdisciplinary consultation consisting of an oncologist, a chemotherapist and a radiotherapist.
- Signed informed consent
Who cannot join
- 3-4 points on the WHO/ECOG scale of assessment of the general condition of the patient
- The complete response of all foci to the chemotherapy.
- Distant metastases only in the brain, without damage to bones and other organs.
- Brain metastasis of more than 3 cm in one dimension, requiring surgical treatment.
- Distant metastasis in the brain stem and spinal cord.
- The size of at least one distant metastasis is more than 5 cm.
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- Previously performed radiation therapy on one of the metastatic foci.
- Metastatic lesion of the pleura, membranes of the brain or peritoneum.
- The impossibility of CTT for all distant metastases, in accordance with the criteria specified in the study design.
- Invasion into great vessels (aorta, carotid arteries, pulmonary arteries, etc.), organs of the digestive tract (esophagus, stomach, intestines), skin.
- Compression of the spinal cord by distant metastasis according to instrumental studies.
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
A. Tsyb Medical Radiological Research Center
Obninsk, Kaluga Oblast, 249033
Konstantin Gordon, PhD, +79105184148, gordon@mrrc.obninsk.ru
Igor Gulidov, PhD
About this study
Official title: Stereotactic Radiation Therapy for Oligometastasis (1-5) in Various Tumor Sites in Comparison to Palliative Care of Oligometastatic Tumors.
Currently, the usual standard of palliative treatment used in patients with diagnosed oligometastatic cancer in accordance with the local clinical recommendations is chemotherapy and/or a symptomatic course of radiation therapy in doses less than ablative ones The aim of the study is to increase the effectiveness of treatment of patients with tumors of various localizations with oligometastases in the bones and internal organs with the help of stereotactic radiation therapy.
The method of stereotactic radiation therapy will be applied in patients with oligometastatic forms of tumors of various localizations after the current line of chemotherapy treatment T1-4, N0-3, M0-1, over 18 years of age at the start of treatment, compared with standard methods of palliative therapy in those same patient models.
Read the detailed description
- A patient with a previously verified diagnosis of a malignant neoplasm of one of the localizations (ICD 10-11 codes С18, С19, С20, С34, С50, С61, С64) who meets the inclusion criteria, after randomization by random numbers into the study group, is carried out:
- 3-dimensional/4-dimensional computed tomography for simulation using specialized fixation devices (the choice of the method of computed tomography and fixing devices will be carried out depending on the location of the metastasis).
- The resulting images are added to the contouring program.
- Delineation of targets and risk organs is performed.
- The clinical volumes and margins for the errors are determined.
- Prescribing the total dose per target and dose limits for critical structures.
- Dosimetric planning of the course of external-beam radiation therapy is carried out.
- Irradiation sessions are carried out on a linear accelerator with a multi-leaf collimator, with the presence of a function for visual control of the target using cone tomography with a kilo-voltage/mega-voltage beam.
- When the target is localized in the lungs, liver, and adrenal glands, in order to reduce the radiation load on the surrounding healthy tissues and achieve the necessary control over the position of metastasis, irradiation is carried out with a deep breath hold, or at certain phases of respiration.
Tumor localization / Description /Total focal dose, Gy/ Number of fractions /Single focal dose, Gy/ Irradiation mode:
Lung Tumors:
- of 3cm or less located in the parenchyma TD45Gy in 3Fx with 15Gy every day
- adjacent to the chest wall or less than 3 cm TD50Gy in 5Fx with 10Gy every day
- within 2 cm of the mediastinum or brachial plexus TD60Gy in 8Fx with 7.5Gy every day
Bones TD24Gy in 3Fx with 8Gy every day
Brain Metastasis
- volume from 0.5 to 5 cm3 TD20-22Gy in 1Fx at a time
- volume of metastasis is from 5 to 10 cm3 TD16-18Gy or TD18-20Gy in 1 Fx at a time
Liver Radiation regimen selection based on tolerance of surrounding tissues and diligence to critical structures TD30-60Gy in 3-8Fx with 6-15Gy every day
Adrenal Glands TD60Gy in 8Fx with 7.5Gy every day
- The expected duration of the patient's participation in clinical testing, a description of the sequence and duration of all periods of clinical testing, including the period of follow-up, if any;
Periods of clinical testing:
- pre-hospital (includes a comprehensive examination of the patient before treatment)
- inpatient (includes pre-radiation training for up to 3 working days, remote radiation therapy, from one to eight working days);
- follow-up - after 3, 6, 9, 12, 18, 24 months;
- collection and processing of the received data.
- Conditions
- Oligometastatic Disease
- Being tested
- stereotactic ablative radiation therapy, palliative radiation therapy, Chemotherapy
- Keywords
- stereotactic radiation therapy, stereotactic body radiation therapy, stereotactic ablative radiation therapy, Oligometastatic Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
stereotactic ablative radiation therapyRadiation
stereotactic ablative radiation therapy in effective doses to each metastatic site
palliative radiation therapyRadiation
palliative radiation therapy (8 Gy/1 Fx, 3 Gy x 10-15 Fx, 4,5 Gy x 5 Fx)
ChemotherapyDrug
prescribed drug line
| Study group | Role | What they receive |
|---|---|---|
| Stereotactic Ablative Radiotherapy (SABR) arm | Experimental | The method of stereotactic radiation therapy in patients with oligometastatic forms of tumors of various localizations after the current line of chemotherapy T1-4, N0-3, M0-1, aged over 18 years at the time of initiation of treatment Receives: Radiation: stereotactic ablative radiation therapy |
| Standart care arm | Active comparator | Palliative radiation therapy or chemotherapy alone in patients with oligometastatic forms of tumors of various localizations after the current line of chemotherapy T1-4, N0-3, M0-1, aged over 18 years at the time of initiation of treatment Receives: Radiation: palliative radiation therapy; Drug: Chemotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free survival
Time period before cancer progression after the treatment, assessed in months
Measured: At approximately end of year 1, 2,3 (study completion)
Time before the current drug line change
Time period before the indication for drug therapy alteration after the treatment, assessed in months
Measured: At approximately the end of years 1, 2, 3 (study completion)
Secondary outcomes (5)
Acute side effects
Local changes of tissues after the treatment, assessed in accordance to CTCAE v5.0
Measured: At approximately the end of months 1, 2, 3 (treatment completion)
Late side effects
Local changes of tissues after the treatment, assessed in accordance to CTCAE v 5.0
Measured: At approximately the end of years 1, 2, 3 (study completion)
Overall survival
Time period before patient death after the treatment, assessed in years
Measured: At approximately the end of years 1, 2, 3 (study completion)
Local metastasis control
Time period before irradiated targets relapse, assessed in years/months
Measured: At approximately the end of years 1, 2, 3 (study completion)
Quality of life Assessed with the Functional Assessment via EQ-5D (EuroQolGroup Scale) and The Numerical Rating Pain Scale
- Functional Assessment via EQ-5D (EuroQolGroup Scale). The scale will be applied before treatment, and after the treatment at month 1, 2, 3, 6, 12 The system comprises 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems (a 1-digit number that expresses the level). The EQ visual-analogue records the patient's self-rated health on a vertical visual analogue scale where the endpoints are labelled 'The best health you can image' and 'The worst health you can image'. It will be used as a quantitative measure of health outcome that reflects the patient's own judgement.
- in case of painful targets The Numerical Rating Pain Scale will be applied before and after the treatment at month 1, 2, 3, 6, 12 . Score 0 (no pain) to 10 (maximal pain)
Measured: At approximately the end of month 1, 2, 3, 6, 12 (study completion)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2024
- Study start31 May 2024
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Oligometastatic DiseaseStudies 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Medical Research Radiological Centre of the Ministry of Health of Russia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Konstantin Gordon, National Medical Research Radiological Centre of the Ministry of Health of Russia
- Investigators
- Konstantin Gordon, Principal investigator, A. Tsyb Medical Radiological Research Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06556550
- Sponsor's protocol ID
- 2024_40_3
- Status last verified
- Aug 2024
- First submitted
- 8 Aug 2024
- Last updated
- 16 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data will be available upon request from the principal investigator for researchers, who meet the criteria for access to confidential data.
Study at a glance
From the registry record, last updated by the sponsor on 16 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Stereotactic Radiation Therapy for Oligometastasis (1-5) in Various Tumor Sites in Comparison to Palliative Care of Oligometastatic Tumors.
- ClinicalTrials.gov ID
- NCT06556550
- Acronym / sponsor ID
- 2024_40_3
- Conditions
- Oligometastatic Disease
- Keywords
- stereotactic radiation therapy, stereotactic body radiation therapy, stereotactic ablative radiation therapy, Oligometastatic Disease
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- National Medical Research Radiological Centre of the Ministry of Health of RussiaUniversity, hospital or other
- Study start
- 31 May 2024 (actual)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2029 (estimated)
- First posted
- 16 Aug 2024 (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.
Currently, the usual standard of palliative treatment used in patients with diagnosed oligometastatic cancer in accordance with the local clinical recommendations is chemotherapy and/or a symptomatic course of radiation therapy in doses less than ablative ones The aim of the study is to increase the effectiveness of treatment of patients with tumors of various localizations with oligometastases in the bones and internal organs with the help of stereotactic radiation therapy.
The method of stereotactic radiation therapy will be applied in patients with oligometastatic forms of tumors of various localizations after the current line of chemotherapy treatment T1-4, N0-3, M0-1, over 18 years of age at the start of treatment, compared with standard methods of palliative therapy in those same patient models.
Detailed description
- A patient with a previously verified diagnosis of a malignant neoplasm of one of the localizations (ICD 10-11 codes С18, С19, С20, С34, С50, С61, С64) who meets the inclusion criteria, after randomization by random numbers into the study group, is carried out:
- 3-dimensional/4-dimensional computed tomography for simulation using specialized fixation devices (the choice of the method of computed tomography and fixing devices will be carried out depending on the location of the metastasis).
- The resulting images are added to the contouring program.
- Delineation of targets and risk organs is performed.
- The clinical volumes and margins for the errors are determined.
- Prescribing the total dose per target and dose limits for critical structures.
- Dosimetric planning of the course of external-beam radiation therapy is carried out.
- Irradiation sessions are carried out on a linear accelerator with a multi-leaf collimator, with the presence of a function for visual control of the target using cone tomography with a kilo-voltage/mega-voltage beam.
- When the target is localized in the lungs, liver, and adrenal glands, in order to reduce the radiation load on the surrounding healthy tissues and achieve the necessary control over the position of metastasis, irradiation is carried out with a deep breath hold, or at certain phases of respiration.
Tumor localization / Description /Total focal dose, Gy/ Number of fractions /Single focal dose, Gy/ Irradiation mode:
Lung Tumors:
- of 3cm or less located in the parenchyma TD45Gy in 3Fx with 15Gy every day
- adjacent to the chest wall or less than 3 cm TD50Gy in 5Fx with 10Gy every day
- within 2 cm of the mediastinum or brachial plexus TD60Gy in 8Fx with 7.5Gy every day
Bones TD24Gy in 3Fx with 8Gy every day
Brain Metastasis
- volume from 0.5 to 5 cm3 TD20-22Gy in 1Fx at a time
- volume of metastasis is from 5 to 10 cm3 TD16-18Gy or TD18-20Gy in 1 Fx at a time
Liver Radiation regimen selection based on tolerance of surrounding tissues and diligence to critical structures TD30-60Gy in 3-8Fx with 6-15Gy every day
Adrenal Glands TD60Gy in 8Fx with 7.5Gy every day
- The expected duration of the patient's participation in clinical testing, a description of the sequence and duration of all periods of clinical testing, including the period of follow-up, if any;
Periods of clinical testing:
- pre-hospital (includes a comprehensive examination of the patient before treatment)
- inpatient (includes pre-radiation training for up to 3 working days, remote radiation therapy, from one to eight working days);
- follow-up - after 3, 6, 9, 12, 18, 24 months;
- collection and processing of the received data.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Stereotactic Ablative Radiotherapy (SABR) arm | Experimental | Radiation: stereotactic ablative radiation therapyThe method of stereotactic radiation therapy in patients with oligometastatic forms of tumors of various localizations after the current line of chemotherapy T1-4, N0-3, M0-1, aged over 18 years at the time of initiation of treatment |
| Standart care arm | Active comparator | Radiation: palliative radiation therapy, Drug: ChemotherapyPalliative radiation therapy or chemotherapy alone in patients with oligometastatic forms of tumors of various localizations after the current line of chemotherapy T1-4, N0-3, M0-1, aged over 18 years at the time of initiation of treatment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Histologically confirmed malignant formation (ICD 10-11 codes С18, С19, С20, С34, С50, С61, С64).
- 0-2 points on the WHO/ECOG scale of assessment of the general condition of the patient.
- The absence of disease progression after the current line of chemotherapeutic treatment.
- The number of oligometastases is not more than 3 in one organ, in the presence of a multi-organ lesion.
- The total number of distant metastases is no more than 5.
Key exclusion criteria (11 listed)
- 3-4 points on the WHO/ECOG scale of assessment of the general condition of the patient
- The complete response of all foci to the chemotherapy.
- Distant metastases only in the brain, without damage to bones and other organs.
- Brain metastasis of more than 3 cm in one dimension, requiring surgical treatment.
- Distant metastasis in the brain stem and spinal cord.
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 |
|---|---|---|
| stereotactic ablative radiation therapystereotactic ablative radiation therapy in effective doses to each metastatic site | Radiation | Stereotactic Ablative Radiotherapy (SABR) arm |
| palliative radiation therapypalliative radiation therapy (8 Gy/1 Fx, 3 Gy x 10-15 Fx, 4,5 Gy x 5 Fx) | Radiation | Standart care arm |
| Chemotherapyprescribed drug line | Drug | Standart care arm |
Primary outcome
Progression-free survival
Time frame: At approximately end of year 1, 2,3 (study completion)
Time period before cancer progression after the treatment, assessed in months
Time before the current drug line change
Time frame: At approximately the end of years 1, 2, 3 (study completion)
Time period before the indication for drug therapy alteration after the treatment, assessed in months
5 secondary outcomes
Acute side effects
Time frame: At approximately the end of months 1, 2, 3 (treatment completion)
Late side effects
Time frame: At approximately the end of years 1, 2, 3 (study completion)
Overall survival
Time frame: At approximately the end of years 1, 2, 3 (study completion)
Local metastasis control
Time frame: At approximately the end of years 1, 2, 3 (study completion)
Quality of life Assessed with the Functional Assessment via EQ-5D (EuroQolGroup Scale) and The Numerical Rating Pain Scale
Time frame: At approximately the end of month 1, 2, 3, 6, 12 (study completion)
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 16 Aug 2024.
- Individual participant dataSharing planned: Yes. Data will be available upon request from the principal investigator for researchers, who meet the criteria for access to confidential data.
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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.
Konstantin Gordon principal investigator
A. Tsyb Medical Radiological Research Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing stereotactic ablative radiation therapy, palliative radiation therapy and Chemotherapy in people with Oligometastatic Disease, run by National Medical Research Radiological Centre of the Ministry of Health of Russia 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 9 inclusion and 11 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 16 Aug 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.
What does this combined 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.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Konstantin Gordon, PhD (+79105184148, gordon@mrrc.obninsk.ru), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-free survival (time frame: At approximately end of year 1, 2,3 (study completion)). 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 16 Aug 2024.