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

ConditionOligometastatic Disease
Trial statusRecruiting
Trial phasePhase 2, Phase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorNational Medical Research Radiological Centre of the Ministry of Health of Russia

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Histologically confirmed malignant formation (ICD 10-11 codes С18, С19, С20, С34, С50, С61, С64).

0-2 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.

Disqualifiers

3-4 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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • stereotactic ablative radiation therapy

    Radiation

    stereotactic ablative radiation therapy in effective doses to each metastatic site

  • palliative radiation therapy

    Radiation

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

  • Chemotherapy

    Drug

    prescribed drug line

Treatment groups

100 Participants
are divided into 2 treatment groups
Group A: Stereotactic Ablative Radiotherapy (SABR) armExperimental treatment 1 intervention
Group B: Standart care armActive comparator 2 interventions

Trial outcomes

Primary outcomes

1

Progression-free survival

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

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

Time before the current drug line change

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

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

Secondary outcomes

1

Acute side effects

Local changes of tissues after the treatment, assessed in accordance to CTCAE v5.0

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

Late side effects

Local changes of tissues after the treatment, assessed in accordance to CTCAE v 5.0

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

Overall survival

Time period before patient death after the treatment, assessed in years

Time frame
At approximately the end of years 1, 2, 3 (study completion)
4

Local metastasis control

Time period before irradiated targets relapse, assessed in years/months

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

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

Lead sponsor

Source ClinicalTrials.gov
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