Clinical trial NCT03461822: Effectiveness of Stereotactic RadioTherapy in Solid Primary Inoperable and Oligometastatic Cancer
Official title: Study of Effectiveness of Stereotactic Body RadioTherapy and Stereotactic RadioSurgery in Solid Primary Inoperable and Oligometastatic Cancer
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Radiotherapy
Lead sponsor: The National Center of Oncology, Azerbaijan
Sponsor class: OTHER_GOV
First posted: 2018-03-12
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The groups will be selected from patients which referred to National Center of Oncology and matching for conducting radiotherapy and Eligibility Criteria.

Brief 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Relapse Rate (local and/or distant)
timeFrame: 5 years
measure: Number of Deaths Due to Any Cause
timeFrame: 5 years
Secondary outcomes:
measure: Incidence of acute toxicity
timeFrame: Up to 90 days after completion of radiation therapy
measure: Incidence of late toxicity
timeFrame: Up to 2 years after completion of radiation therapy
Other outcomes:
Locations:
city: Baku
country: Azerbaijan
facility: National Center of Oncology
Study officials:
References: