Effectiveness of Stereotactic RadioTherapy in Solid Primary Inoperable and Oligometastatic Cancer

NCT03461822 | Unknown

• 1 other identifier: MOM-0005
• Study Type: observational
• Target: 400
• Locations: 1 country
• Sites: 1

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.

Conditions

Radiotherapy

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• Incidence of acute toxicity

  Up to 90 days after completion of radiation therapy

• Incidence of late toxicity

  Up to 2 years after completion of radiation therapy

Study Arms (4)

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• Progression of primary site of metastatic cancer.
• Pregnancy or Breast-Feeding.
• Decompensated concomitant diseases.

Sponsors & Collaborators

• The National Center of Oncology, Azerbaijan: lead

Study Sites (1)

National Center of Oncology

Baku, AZ1011, Azerbaijan

RECRUITING

Central Study Contacts

Azer Aliyev, PhD

CONTACT

+994504054025; a.aliyev@yahoo.de

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Radiation Oncologist, PhD

Study Record Dates

• First Submitted: February 20, 2018
• First Posted: March 12, 2018
• Study Start: March 1, 2013
• Primary Completion: December 1, 2019
• Study Completion: January 1, 2020
• Last Updated: March 12, 2018

Record last verified: 2018-03

Data Sharing

• IPD Sharing: Will not share

Locations

AZ (1)