Effectiveness of Stereotactic RadioTherapy in Solid Primary Inoperable and Oligometastatic Cancer

Overview

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 Title of Study: “Study of Effectiveness of Stereotactic Body RadioTherapy and Stereotactic RadioSurgery in Solid Primary Inoperable and Oligometastatic Cancer”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: December 2019

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.

Arms, Groups and Cohorts

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

Clinical Trial Outcome Measures

Primary Measures

  • Relapse Rate (local and/or distant)
    • Time Frame: 5 years
    • clinical-instrumental or laboratory signs of local and/or distant recurrences of previously diagnosed oncological diaseases
  • Number of Deaths Due to Any Cause
    • Time Frame: 5 years
    • Deaths due to any complications or progression of previously diagnosed oncological diaseases

Secondary Measures

  • Incidence of acute toxicity
    • Time Frame: Up to 90 days after completion of radiation therapy
    • 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.
  • Incidence of late toxicity
    • Time Frame: Up to 2 years after completion of radiation therapy
    • Number of adverse effects of irradiation observed in the patients after 3 months from the begginning of the treatment, measured by LENT SOMA scale.

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • The National Center of Oncology, Azerbaijan
  • Provider of Information About this Clinical Study
    • Principal Investigator: Azer Aliyev, Radiation Oncologist, PhD – The National Center of Oncology, Azerbaijan
  • Overall Contact(s)
    • Azer Aliyev, PhD, +994504054025, a.aliyev@yahoo.de

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