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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT03461822 |
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Date of registration:
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20/02/2018 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Effectiveness of Stereotactic RadioTherapy in Solid Primary Inoperable and Oligometastatic Cancer
ESRTSPIOC |
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Scientific title:
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Study of Effectiveness of Stereotactic Body RadioTherapy and Stereotactic RadioSurgery in Solid Primary Inoperable and Oligometastatic Cancer |
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Date of first enrolment:
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March 2013 |
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Target sample size:
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400 |
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Recruitment status: |
Unknown status |
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URL:
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https://clinicaltrials.gov/show/NCT03461822 |
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Study type:
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Observational |
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Study design:
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Phase:
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Countries of recruitment
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Azerbaijan
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Contacts
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Name:
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Aziz Aliyev, Professor |
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Address:
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Telephone:
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+994504807021 |
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Email:
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internationalnoc@gmail.com |
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Affiliation:
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Name:
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Azer Aliyev, PhD |
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Address:
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Telephone:
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+994504054025 |
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Email:
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a.aliyev@yahoo.de |
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- 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.
- 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.
Exclusion Criteria:
- Progression of primary site of metastatic cancer.
- Pregnancy or Breast-Feeding.
- Decompensated concomitant diseases.
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Radiotherapy
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Primary Outcome(s)
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Number of Deaths Due to Any Cause
[Time Frame: 5 years]
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Relapse Rate (local and/or distant)
[Time Frame: 5 years]
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Secondary Outcome(s)
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Incidence of acute toxicity
[Time Frame: Up to 90 days after completion of radiation therapy]
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Incidence of late toxicity
[Time Frame: Up to 2 years after completion of radiation therapy]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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