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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03461822
Other study ID # MOM-0005
Secondary ID
Status Recruiting
Phase N/A
First received February 20, 2018
Last updated March 5, 2018
Start date March 2013
Est. completion date January 2020

Study information

Verified date March 2018
Source The National Center of Oncology, Azerbaijan
Contact Azer Aliyev, PhD
Phone +994504054025
Email a.aliyev@yahoo.de
Is FDA regulated No
Health authority
Study type Observational

Clinical 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 400
Est. completion date January 2020
Est. primary completion date December 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
Azerbaijan National Center of Oncology Baku

Sponsors (1)

Lead Sponsor Collaborator
The National Center of Oncology, Azerbaijan

Country where clinical trial is conducted

Azerbaijan, 

Outcome

Type Measure Description Time frame Safety issue
Primary Relapse Rate (local and/or distant) clinical-instrumental or laboratory signs of local and/or distant recurrences of previously diagnosed oncological diaseases 5 years
Primary Number of Deaths Due to Any Cause Deaths due to any complications or progression of previously diagnosed oncological diaseases 5 years
Secondary 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. Up to 90 days after completion of radiation therapy
Secondary 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. Up to 2 years after completion of radiation therapy
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