Effectiveness of Stereotactic RadioTherapy in Solid Primary Inoperable and Oligometastatic Cancer

• Conditions: Radiotherapy

• Registration Number: NCT03461822
• Lead Sponsor: The National Center of Oncology, Azerbaijan

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.

Study Timeline

• Study Start: 2013-03
• Study First Submitted: 2018-02-20
• Status Verified: 2018-03
• Study First Submitted QC: 2018-03-05
• Last Update Submitted: 2018-03-05
• Study First Posted: 2018-03-12
• Last Update Posted: 2018-03-12
• Primary Completion: 2019-12
• Study Completion: 2020-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 400

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Incidence of acute toxicity	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	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.

Trial Locations

Locations (1)

National Center of Oncology; 🇦🇿 Baku, Azerbaijan