Observational cohort of patients treated with stereotactic radiotherapy for Oligo LYMPh nOde and other soft tissue metastasiS

Observational cohort of patients treated with stereotactic radiotherapy for Oligo LYMPh nOde and other soft tissue metastasiS - OLYMPOS cohort

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON48987

Enrollment

700

Registered

2018-03-06

Start date

2018-07-22

Completion date

Unknown

Last updated

2024-04-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

metastases soft tissue oligometastases

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: - Is referred for, or will receive, stereotactic radiotherapy of a soft tissue metastasis with a localization other than brain or lung. - Informed consent - at least - for use of routinely collected clinical data for research purposes (including follow up data in other hospitals).

Exclusion criteria

Exclusion criteria: • Age

Design outcomes

Primary

Measure	Time frame
5.1.1 Main study parameters Clinical study parameters that will be collected: Baseline demographics • Gender • Date of birth Oncological history • Primary tumor • Date of diagnosis primary tumor • TNM-stage at date diagnosis primary tumor • Previous oncological treatments • Date of last oncological treatment • Previous or current diagnosis of metastases other than lymph nodesoft tissue target metastases • Date of diagnosis of metastases other than soft tissue target lymph node metastases • Type of metastases other than soft tissue target lymph node metastases (bone, liver, brain, lung, visceral) • Previous or current treatment for metastases other than soft tissue target lymph node metastases • Date of diagnosis first soft tissue target lymph node metastases • Imaging modalities used for diagnosis soft tissue target lymph node metastases • Location of all present soft tissue target lymph node metastases • In case of prostate cancer: PSA values since diagnosis primary tumor Symptoms at baseline • Existence of symptoms from soft tissue target lymph node metastases • Numeric Rating Score (NRS) pain score • Karnofsky performance status Treatment data • Starting date of radiotherapy treatment • Dose, fractions and technique of radiotherapy treatment, type of radiotherapy treatment facility, type of online position verification imaging, treatment margins used, re-irradiation* 5.1.2 Main study endpoints Clinical registration of toxicity: For all participants in the study, toxicity will be registered by the treating radiation oncologist according to Common Terminology Criteria for Adverse Events (CTCAE version 4). Registration in the electronic patient medical file (Hix) will be done at 1 and 4 weeks and 3 months after treatment. The following side effects will be scored, depending on nodal location: For pelvic soft tissue targetslymph nodes: • Fatigue • Fractures • Lymphedema • Neuralgia • Pain • Paresthesia • Diarrhea • Gast	—

Measure

Time frame

5.1.1 Main study parameters Clinical study parameters that will be collected: Baseline demographics • Gender • Date of birth Oncological history • Primary tumor • Date of diagnosis primary tumor • TNM-stage at date diagnosis primary tumor • Previous oncological treatments • Date of last oncological treatment • Previous or current diagnosis of metastases other than lymph nodesoft tissue target metastases • Date of diagnosis of metastases other than soft tissue target lymph node metastases • Type of metastases other than soft tissue target lymph node metastases (bone, liver, brain, lung, visceral) • Previous or current treatment for metastases other than soft tissue target lymph node metastases • Date of diagnosis first soft tissue target lymph node metastases • Imaging modalities used for diagnosis soft tissue target lymph node metastases • Location of all present soft tissue target lymph node metastases • In case of prostate cancer: PSA values since diagnosis primary tumor Symptoms at baseline • Existence of symptoms from soft tissue target lymph node metastases • Numeric Rating Score (NRS) pain score • Karnofsky performance status Treatment data • Starting date of radiotherapy treatment • Dose, fractions and technique of radiotherapy treatment, type of radiotherapy treatment facility, type of online position verification imaging, treatment margins used, re-irradiation* 5.1.2 Main study endpoints Clinical registration of toxicity: For all participants in the study, toxicity will be registered by the treating radiation oncologist according to Common Terminology Criteria for Adverse Events (CTCAE version 4). Registration in the electronic patient medical file (Hix) will be done at 1 and 4 weeks and 3 months after treatment. The following side effects will be scored, depending on nodal location: For pelvic soft tissue targetslymph nodes: • Fatigue • Fractures • Lymphedema • Neuralgia • Pain • Paresthesia • Diarrhea • Gast

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Countries

Netherlands

Outcome results