Effectiveness of Stereotactic RadioTherapy in Solid Primary Inoperable and Oligometastatic Cancer

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

400 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-03-31

Study Completion Date

2020-01-31

Brief Summary

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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.

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Detailed Description

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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

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Radiotherapy

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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SRT in primary-inoperable solid tumors

stereotactic radiotherapy in hypofractionated regimes in 1-5 fractions in primary-inoperable solid tumors

No interventions assigned to this group

Classic radiotherapy in primary-inoperable solid tumors

Classic radiotherapy in 1.8-2.0 Gy per fraction in primary-inoperable solid tumors

No interventions assigned to this group

SRT in oligometastatic cancer

stereotactic radiotherapy in hypofractionated regimes in 1-5 fractions in oligometastatic cancer

No interventions assigned to this group

Classic radiotherapy in oligometastatic cancer

Classic radiotherapy in 1.8-2.0 Gy per fraction in oligometastatic cancer

No interventions assigned to this group

Eligibility 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.