RadiotherapyESRTSPIOCNCT03461822
Effectiveness of Stereotactic RadioTherapy in Solid Primary Inoperable and Oligometastatic Cancer
An observational study of Radiotherapy, run by The National Center of Oncology, Azerbaijan at 1 site in Azerbaijan.
Trial summary
The purpose of this study is to development of more effective treatment tactics of the stereotactic radiotherapy and radiosurgery alone and together with classic radiation therapy in primary inoperabel solid tumors and oligometastastatic cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Radiotherapy
- How many people
- 400 participants
- Where
- 1 siteAzerbaijan
- Study dates
- Mar 2013to Jan 2020
- Phase
- Observational
- 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
Study population: The groups will be selected from patients which referred to National Center of Oncology and matching for conducting radiotherapy and Eligibility Criteria.
Who may be able to join
- Histologically confirmed primary-inoperable solid tumors or oligometastatic cancer.
- Acceptance of patient by surgeon as non-operabel or refusing of surgery.
- No more than 4 metastatic foci in irradiated organ.
- Karnofsky scale more than 60.
- Age ≥18 years.
- Estimated duration of life >3 months.
Show all 15Show fewer
- Hemoglobin ≥ 8 g/dl.
- Absolute neutrophil count at least 1,500/mm^3.
- Platelet count at least 70,000/mm^3.
- Bilirubin no greater than 1.5 times normal.
- SGOT and SGPT no greater than 3 times normal.
- Creatinine less than 1.5 mg/dL. PT-INR/APTT less than 1.5.
- Last patients data no older than 1 month.
- No prior radiotherapy of same location.
- Prior chemottherapy more than 2 weeks ago.
Who cannot join
- Progression of primary site of metastatic cancer.
- Pregnancy or Breast-Feeding.
- Decompensated concomitant diseases.
Trial locations and contacts
1 site in 1 country.
Azerbaijan1 site, 1 recruiting
- Recruiting
National Center of Oncology
Baku, AZ1011
Aziz Aliyev, Professor, +994504807021, internationalnoc@gmail.com
Azer Aliyev, PhD
About this study
Official title: Study of Effectiveness of Stereotactic Body RadioTherapy and Stereotactic RadioSurgery in Solid Primary Inoperable and Oligometastatic Cancer
The purpose of this study is to development of more effective treatment tactics of the stereotactic radiotherapy and radiosurgery alone and together with classic radiation therapy in primary inoperabel solid tumors and oligometastastatic cancer.
Read the detailed description
Despite the fact that of many investigations in the world clinical researches, the SRT of primary-inoperabel and metastatic solid tumors combined with conventional and conformal radiation therapy methods the possibility of the sequences, the optimal fractions of the regimes and doses which determines normal tissues toxic manifestations, implementation of prevention, have not been solved yet.
The conducted research works to study quality of life for improving the social status of patients with primary-inoperable and metastatic solid tumors, is not fully resolved.
Thus, preparing of highly effective treatment tactics in primary-inoperable and metastatic solid tumors, is one of the most important problems of modern clinical oncology and this fact gives grounds to carry out the planned research work.
- Conditions
- Radiotherapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| SRT in primary-inoperable solid tumors | stereotactic radiotherapy in hypofractionated regimes in 1-5 fractions in primary-inoperable solid tumors | |
| Classic radiotherapy in primary-inoperable solid tumors | Classic radiotherapy in 1.8-2.0 Gy per fraction in primary-inoperable solid tumors | |
| SRT in oligometastatic cancer | stereotactic radiotherapy in hypofractionated regimes in 1-5 fractions in oligometastatic cancer | |
| Classic radiotherapy in oligometastatic cancer | Classic radiotherapy in 1.8-2.0 Gy per fraction in oligometastatic cancer |
What is being measured
The primary outcome is the main question the study is designed to answer.
Relapse Rate (local and/or distant)
clinical-instrumental or laboratory signs of local and/or distant recurrences of previously diagnosed oncological diaseases
Measured: 5 years
Number of Deaths Due to Any Cause
Deaths due to any complications or progression of previously diagnosed oncological diaseases
Measured: 5 years
Secondary outcomes (2)
Incidence of acute toxicity
Number of adverse effects of irradiation observed in the patients within 3 months from the begginning of the treatment, measured by CTCAE 4.03 and/or EORTC/RTOG scales.
Measured: Up to 90 days after completion of radiation therapy
Incidence of late toxicity
Number of adverse effects of irradiation observed in the patients after 3 months from the begginning of the treatment, measured by LENT SOMA scale.
Measured: Up to 2 years after completion of radiation therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2018
- Study startMar 2013
- Primary completionDec 2019 (estimated)
- Study completionJan 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for RadiotherapyStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The National Center of Oncology, Azerbaijan
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Azer Aliyev, The National Center of Oncology, Azerbaijan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03461822
- Sponsor's protocol ID
- MOM-0005
- Acronym
- ESRTSPIOC
- Status last verified
- Mar 2018
- First submitted
- 20 Feb 2018
- Last updated
- 12 Mar 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Effectiveness of Stereotactic Body RadioTherapy and Stereotactic RadioSurgery in Solid Primary Inoperable and Oligometastatic Cancer
- ClinicalTrials.gov ID
- NCT03461822
- Acronym / sponsor ID
- ESRTSPIOC / MOM-0005
- Conditions
- Radiotherapy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- The National Center of Oncology, AzerbaijanOther government
- Study start
- Mar 2013
- Primary completion
- Dec 2019 (estimated)
- Study completion
- Jan 2020 (estimated)
- First posted
- 12 Mar 2018 (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.
The purpose of this study is to development of more effective treatment tactics of the stereotactic radiotherapy and radiosurgery alone and together with classic radiation therapy in primary inoperabel solid tumors and oligometastastatic cancer.
Detailed description
Despite the fact that of many investigations in the world clinical researches, the SRT of primary-inoperabel and metastatic solid tumors combined with conventional and conformal radiation therapy methods the possibility of the sequences, the optimal fractions of the regimes and doses which determines normal tissues toxic manifestations, implementation of prevention, have not been solved yet.
The conducted research works to study quality of life for improving the social status of patients with primary-inoperable and metastatic solid tumors, is not fully resolved.
Thus, preparing of highly effective treatment tactics in primary-inoperable and metastatic solid tumors, is one of the most important problems of modern clinical oncology and this fact gives grounds to carry out the planned research work.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| SRT in primary-inoperable solid tumors | – | –stereotactic radiotherapy in hypofractionated regimes in 1-5 fractions in primary-inoperable solid tumors |
| Classic radiotherapy in primary-inoperable solid tumors | – | –Classic radiotherapy in 1.8-2.0 Gy per fraction in primary-inoperable solid tumors |
| SRT in oligometastatic cancer | – | –stereotactic radiotherapy in hypofractionated regimes in 1-5 fractions in oligometastatic cancer |
| Classic radiotherapy in oligometastatic cancer | – | –Classic radiotherapy in 1.8-2.0 Gy per fraction in oligometastatic cancer |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The groups will be selected from patients which referred to National Center of Oncology and matching for conducting radiotherapy and Eligibility Criteria.
Key inclusion criteria (15 listed)
- Histologically confirmed primary-inoperable solid tumors or oligometastatic cancer.
- Acceptance of patient by surgeon as non-operabel or refusing of surgery.
- No more than 4 metastatic foci in irradiated organ.
- Karnofsky scale more than 60.
- Age ≥18 years.
Key exclusion criteria (3 listed)
- Progression of primary site of metastatic cancer.
- Pregnancy or Breast-Feeding.
- Decompensated concomitant diseases.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Relapse Rate (local and/or distant)
Time frame: 5 years
clinical-instrumental or laboratory signs of local and/or distant recurrences of previously diagnosed oncological diaseases
Number of Deaths Due to Any Cause
Time frame: 5 years
Deaths due to any complications or progression of previously diagnosed oncological diaseases
2 secondary outcomes
Incidence of acute toxicity
Time frame: Up to 90 days after completion of radiation therapy
Incidence of late toxicity
Time frame: Up to 2 years after completion of radiation therapy
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2018.
- Individual participant dataSharing planned: No
Related trials for Radiotherapy
RecruitingObservational study
Proton Re-irradiation in Patients With Recurrent or Second Primary Head and Neck Cancer , a Multicentre Phase II Single Arm Trial
Head & Neck Cancer
RecruitingPhase 2
Proton Spatially Fractionated Radiotherapy or Photon Stereotactic Body Radiotherapy in Combination With Pembrolizumab Before Surgery for the Treatment of Locally Advanced and Radiation-Naive Locoregionally Recurrent Oral Cavity Cancer, OSPRI Trial
Locally Advanced Oral Cavity Squamous Cell Carcinoma, Locally Recurrent Oral Cavity Squamous Cell Carcinoma
Not yet recruitingPhase 2
Toripalimab and Lenvatinib With or Without SBRT Before Surgery for Non-Clear Cell Kidney Cancer
Nonmetastatic Locally Advanced Non-Clear Cell Renal Cell Carcinoma
RecruitingObservational study
A Study of Neurocognitive Tests and Questionnaires for People With Head and Neck Cancer Who Are Undergoing Radiation Therapy
Head and Neck Cancer
RecruitingPhase 2
SBRT With Immunotherapy and Atezo-Bev in HCC With Major Portal Vein Thrombosis
HCC
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Radiotherapy, run by The National Center of Oncology, Azerbaijan at 1 site in Azerbaijan.
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 15 inclusion and 3 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 12 Mar 2018. 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 Azerbaijan. 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 Azer Aliyev, PhD (+994504054025, a.aliyev@yahoo.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Relapse Rate (local and/or distant) (time frame: 5 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 12 Mar 2018.