OLIGO-10: Stereotactic Ablative Radiation Therapy for Metastatic Patients With 6 to 10 Metastatic Sites

NCT06856603 | Recruiting Phase 2

• 1 other identifier: 2024_06_13
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

Currently, the standard of care for patients with diagnosed metastatic cancer is drug therapy (chemotherapy, targeted therapy, or immunotherapy). However, the approach to oligometastatic disease (1-5 metastases) is evolving. An increasing number of de novo, persistent, and progressive oligometastatic tumors are now being treated with curative intent, with radiation therapy among the most effective treatment options, applied to metastatic sites in ablative doses. Emerging results from the SABR-COMET 3 and 5 trials, which investigate stereotactic ablative radiotherapy for patients with 1-3 and 1-5 metastatic sites, demonstrate a clear improvement in overall survival. However, patients with more than five metastases remain in a gray area. The aim of our study is to assess the safety and effectiveness of radiation treatment for patients with tumors of various localizations and 6 to 10 metastases in the bones and internal organs. Stereotactic radiation therapy will be applied to patients with persistent or progressive metastatic forms of tumors, without changing their ongoing drug therapy regimen.

Conditions

Metastatic Disease

Keywords

Metastatic Disease; Stereotactic radiation therapy; Stereotactic body radiation therapy; Stereotactic ablative radiation therapy; Oligometastatic Disease

Outcome Measures

Primary Outcomes (1)

• Treatment safety

  Radiation-induced toxicity (type and corresponding grade 1 to 5) will be assessed using the Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 scale.

  End of years 1, 2, 3, 4, 5 (study completion)

Secondary Outcomes (4)

• Effectiveness (PFS)

  From the date of initiation until the date of documented disease progression, assessed over a period of up to 60 months.

• Effectiveness (LC)

  From the date of initiation until the date of documented radiological signs of metastasis relapse, assessed over a period of up to 60 months.

• Effectiveness (OS)

  From the date of initiation until the date of death from any cause, assessed over a period of up to 60 months.

• Time-to-CTX-change

  End of years 1, 2, 3, 4, 5 (study completion)

Study Arms (1)

A single-arm: Stereotactic Ablative Radiotherapy (SABR) for 6-10 mts

OTHER

The method of stereotactic ablative radiation therapy will be used in patients with metastatic tumors (6-10 sites) of various localizations, following the current line of chemotherapy (T1-4, N0-3, M0-1), and who are over 18 years old at the time of treatment initiation.

Radiation: stereotactic radiation therapy in ablative doses to each metastatic site

Interventions

stereotactic radiation therapy in ablative doses to each metastatic site RADIATION

Stereotactic ablative radiation therapy will be utilized for each metastatic site in patients with 6 to 10 sites of metastasis (persistent or progressive disease).

A single-arm: Stereotactic Ablative Radiotherapy (SABR) for 6-10 mts

Eligibility Criteria

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

You may qualify if:

• ECOG status 0-3
• Persistent or progressive cancer disease with 6 to 10 metastases
• ≤ 5 metastases in one organ
• Life expectancy \> 6 months for intracranial lesions
• Inability to surgically resect all metastatic lesions
• Signed informed consent

You may not qualify if:

• ECOG status 4
• De novo metastatic disease
• Radiological complete response after drug therapy
• Brain metastasis only
• Brain metastasis \> 3 cm, requiring neurosurgery
• Size of any metastasis \> 5 cm
• Previous radiation therapy for any metastatic site
• Leptomeningeal, pleural, or peritoneal carcinomatosis
• Spinal cord compression, requiring neurosurgery
• Invasion of great vessels, skin, or GI tract
• Unsigned informed consent

Sponsors & Collaborators

• National Medical Research Radiological Centre of the Ministry of Health of Russia: lead

Study Sites (1)

A. Tsyb Medical Radiological Research Center

Obninsk, Kaluga Oblast, 249033, Russia

RECRUITING

MeSH Terms

Conditions

Neoplasm Metastasis

Interventions

Radiosurgery

Condition Hierarchy (Ancestors)

Neoplastic Processes; Neoplasms; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Radiotherapy; Therapeutics; Stereotaxic Techniques; Neurosurgical Procedures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Andrey Kaprin, PhD

  National Medical Research Radiological Centre of the Ministry of Health of Russia

  STUDY CHAIR

Central Study Contacts

Konstantin gordon, PhD

CONTACT

0079105184148; dr_gordon@yahoo.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: SABR for Extra- and Intracranial Metastatic Disease with 6-10 Sites

Study Record Dates

• First Submitted: February 12, 2025
• First Posted: March 4, 2025
• Study Start: February 7, 2025
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2030
• Last Updated: March 4, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: unlimited
• Access Criteria: informed consent for personal data non-disclosure

Locations

RU (1)