Stereotactic Radiotherapy for Oligometastasis (1-5) in Various Tumor Sites vs. Palliative Care

NCT06556550 | Recruiting Phase 2

• 1 other identifier: 2024_40_3
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

Currently, the usual standard of palliative treatment used in patients with diagnosed oligometastatic cancer in accordance with the local clinical recommendations is chemotherapy and/or a symptomatic course of radiation therapy in doses less than ablative ones The aim of the study is to increase the effectiveness of treatment of patients with tumors of various localizations with oligometastases in the bones and internal organs with the help of stereotactic radiation therapy. The method of stereotactic radiation therapy will be applied in patients with oligometastatic forms of tumors of various localizations after the current line of chemotherapy treatment T1-4, N0-3, M0-1, over 18 years of age at the start of treatment, compared with standard methods of palliative therapy in those same patient models.

Conditions

Oligometastatic Disease

Keywords

stereotactic radiation therapy; stereotactic body radiation therapy; stereotactic ablative radiation therapy; Oligometastatic Disease

Outcome Measures

Primary Outcomes (2)

• Progression-free survival

  Time period before cancer progression after the treatment, assessed in months

  At approximately end of year 1, 2,3 (study completion)

• Time before the current drug line change

  Time period before the indication for drug therapy alteration after the treatment, assessed in months

  At approximately the end of years 1, 2, 3 (study completion)

Secondary Outcomes (5)

• Acute side effects

  At approximately the end of months 1, 2, 3 (treatment completion)

• Late side effects

  At approximately the end of years 1, 2, 3 (study completion)

• Overall survival

  At approximately the end of years 1, 2, 3 (study completion)

• Local metastasis control

  At approximately the end of years 1, 2, 3 (study completion)

• Quality of life Assessed with the Functional Assessment via EQ-5D (EuroQolGroup Scale) and The Numerical Rating Pain Scale

  At approximately the end of month 1, 2, 3, 6, 12 (study completion)

Study Arms (2)

Stereotactic Ablative Radiotherapy (SABR) arm

EXPERIMENTAL

The method of stereotactic radiation therapy in patients with oligometastatic forms of tumors of various localizations after the current line of chemotherapy T1-4, N0-3, M0-1, aged over 18 years at the time of initiation of treatment

Radiation: stereotactic ablative radiation therapy

Standart care arm

ACTIVE COMPARATOR

Palliative radiation therapy or chemotherapy alone in patients with oligometastatic forms of tumors of various localizations after the current line of chemotherapy T1-4, N0-3, M0-1, aged over 18 years at the time of initiation of treatment

Radiation: palliative radiation therapy; Drug: Chemotherapy

Interventions

stereotactic ablative radiation therapy RADIATION

stereotactic ablative radiation therapy in effective doses to each metastatic site

Stereotactic Ablative Radiotherapy (SABR) arm

palliative radiation therapy RADIATION

palliative radiation therapy (8 Gy/1 Fx, 3 Gy x 10-15 Fx, 4,5 Gy x 5 Fx)

Standart care arm

Chemotherapy DRUG

prescribed drug line

Standart care arm

Eligibility Criteria

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

You may qualify if:

• Histologically confirmed malignant formation (ICD 10-11 codes С18, С19, С20, С34, С50, С61, С64).
• points on the WHO/ECOG scale of assessment of the general condition of the patient.
• The absence of disease progression after the current line of chemotherapeutic treatment.
• The number of oligometastases is not more than 3 in one organ, in the presence of a multi-organ lesion.
• The total number of distant metastases is no more than 5.
• Life expectancy of more than 6 months for brain metastases (GPA-score)
• The possibility of SBRT for all distant metastases, in accordance with the criteria specified in the study design.
• Signed informed consent

You may not qualify if:

• points on the WHO/ECOG scale of assessment of the general condition of the patient
• The complete response of all foci to the chemotherapy.
• Distant metastases only in the brain, without damage to bones and other organs.
• Brain metastasis of more than 3 cm in one dimension, requiring surgical treatment.
• Distant metastasis in the brain stem and spinal cord.
• The size of at least one distant metastasis is more than 5 cm.
• Previously performed radiation therapy on one of the metastatic foci.
• Metastatic lesion of the pleura, membranes of the brain or peritoneum.
• The impossibility of CTT for all distant metastases, in accordance with the criteria specified in the study design.
• Invasion into great vessels (aorta, carotid arteries, pulmonary arteries, etc.), organs of the digestive tract (esophagus, stomach, intestines), skin.
• Compression of the spinal cord by distant metastasis according to instrumental studies.

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

Interventions

Drug Therapy

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

• Konstantin Gordon

  A. Tsyb Medical Radiological Research Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Konstantin Gordon, PhD

CONTACT

+79105184148; gordon@mrrc.obninsk.ru

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Researcher

Study Record Dates

• First Submitted: August 8, 2024
• First Posted: August 16, 2024
• Study Start: May 31, 2024
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2029
• Last Updated: August 16, 2024

Record last verified: 2024-08

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)