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

Study of Effectiveness of Stereotactic Body RadioTherapy and Stereotactic RadioSurgery in Solid Primary Inoperable and Oligometastatic Cancer

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.

Study Overview

• Status: Unknown
• Conditions: Radiotherapy

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 Type: Observational
• Enrollment (Anticipated): 400

Contacts and Locations

Study Locations

• Azerbaijan
  • Baku, Azerbaijan, AZ1011
    • Recruiting
    • National Center of Oncology
    • Contact: Aziz Aliyev, Professor; Phone Number: +994504807021; Email: internationalnoc@gmail.com
    • Principal Investigator: Azer Aliyev, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: The National Center of Oncology, Azerbaijan

Study record dates

Study Major Dates

• Study Start: March 1, 2013
• Primary Completion (ANTICIPATED): December 1, 2019
• Study Completion (ANTICIPATED): January 1, 2020

Study Registration Dates

• First Submitted: February 20, 2018
• First Submitted That Met QC Criteria: March 5, 2018
• First Posted (ACTUAL): March 12, 2018

Study Record Updates

• Last Update Posted (ACTUAL): March 12, 2018
• Last Update Submitted That Met QC Criteria: March 5, 2018
• Last Verified: March 1, 2018

More Information

Terms related to this study

• Other Study ID Numbers: MOM-0005

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO