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Effectiveness of Stereotactic RadioTherapy in Solid Primary Inoperable and Oligometastatic Cancer (ESRTSPIOC)

T

The National Center of Oncology, Azerbaijan

Status

Unknown

Conditions

Radiotherapy

Study type

Observational

Funder types

Other

Identifiers

NCT03461822
MOM-0005

Details and patient eligibility

About

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.

Full 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.

Enrollment

400 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

400 participants in 4 patient groups

SRT in primary-inoperable solid tumors
Description:
stereotactic radiotherapy in hypofractionated regimes in 1-5 fractions in primary-inoperable solid tumors
Classic radiotherapy in primary-inoperable solid tumors
Description:
Classic radiotherapy in 1.8-2.0 Gy per fraction in primary-inoperable solid tumors
SRT in oligometastatic cancer
Description:
stereotactic radiotherapy in hypofractionated regimes in 1-5 fractions in oligometastatic cancer
Classic radiotherapy in oligometastatic cancer
Description:
Classic radiotherapy in 1.8-2.0 Gy per fraction in oligometastatic cancer

Trial contacts and locations

1

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Central trial contact

Azer Aliyev, PhD

Data sourced from clinicaltrials.gov

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