Stereotaktisk ablativ strålebehandling til oligo-progressiv ikke-småcellet lungekræft (SUPPRESS-NSCLC)
Stereotaktisk ablativ strålebehandling for oligo-progressiv sygdom, der er modstandsdygtig over for systemisk terapi ved ikke-småcellet lungekræft: Et registerbaseret fase II randomiseret forsøg
A registry-based randomized screening phase II trial. A total of 68 patients with metastatic non small cell lung cancer on systemic therapy with oligoprogression to 1-5 extracranial lesions will be randomized using a 1:1 ratio to standard of care (begin next-line systemic therapy, best supportive care, continue current systemic line, based on treating physician decision) vs. receive stereotactic ablative radiotherapy to all oligoprogressive lesions while continuing their current systemic therapy.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Fase 2
Kontakter og lokationer
Studiesteder
-
-
Quebec
-
Montreal, Quebec, Canada, H2X 3E4
- Centre Hospitalier de l'Université de Montréal
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
- Age ≥18 years
- Metastatic NSCLC enrolled in our CRCHUM Lung Cancer Registry and co-enrolled to the PERa registry
- Ability to provide written informed consent
- Eastern Cooperative Oncology Group (ECOG) performance status 0-3
- Oligoprogression to 1-5 extracranial lesions ≤ 5cm and involving ≤ 3 organs. Progression at the primary tumor site should be counted within the total of 5 lesions. For patients with lymph node metastases, each node is counted as one site of metastasis.
- Oligoprogression while on systemic therapy (any line)
- Patients with brain metastasis are allowed; brain metastasis are not counted in the maximum number of lesions and should be treated as per standard of care
- All sites of disease can, in the opinion of the investigator, be safely treated and targetable with SABR (taking into account prior local therapy, organ function and underlying medical condition such as inflammatory bowel disease, pulmonary fibrosis, etc.)
- Patients with prior metastases that have been treated with ablative therapies (e.g. radiotherapy, surgery or radiofrequency ablation) before their current line of systemic therapy, are eligible.
Exclusion Criteria:
- Any lesion beyond 5 cm
- Pregnancy or breastfeeding
- Any medical condition that could, in the opinion of the investigator, preclude radiotherapy or prevent follow-up after radiotherapy.
- Presence of spinal cord compression Metastatic disease that invades the GI tract (including esophagus, stomach, small or large bowel)
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Enkelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Aktiv komparator: Standard of care
Switch to subsequent systemic therapy line, best supportive care or continue current systemic line |
SABR to all oligoprogressive lesions + continuation of current systemic therapy |
|
Eksperimentel: Experimental SABR arm
Definitive SABR to oligoprogressive lesions + continue current systemic therapy |
Patients on the standard arm will be treated as per standard of care in our institution. Treatment options could include switching to next systemic therapy line, best supportive care or continuing on current systemic therapy. |
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
PFS
Tidsramme: 5 years
|
PFS defined from randomization to disease progression at any site or death |
5 years
|
|
OS
Tidsramme: 5 years
|
OS defined as time from randomization to time of death from any cause. |
5 years
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Quality of life Measured using the FACT-G tool, lung cancer-related patient reported outcome- CTCAE (PRO-CTCAE)
Tidsramme: 5 years
|
Measured using the FACT-G tool, lung cancer-related patient reported outcome- CTCAE (PRO-CTCAE) |
5 years
|
|
Quality of life 5-level EQ-5D (EQ-5D-5L)
Tidsramme: 5 years
|
questionnaire |
5 years
|
|
Grade ≥ 3 toxicity
Tidsramme: 5 years
|
Measured using the Common Terminology Criteria for Adverse Events (CTCAE v5.0) |
5 years
|
|
Local control
Tidsramme: 5 years
|
Defined as time from the end of SABR treatment to date of local failure and will be measured only in the experimental arm |
5 years
|
|
Time to next systemic therapy
Tidsramme: 5 years
|
Defined as time from randomization to time of subsequent therapy line |
5 years
|
Samarbejdspartnere og efterforskere
Efterforskere
- Studiestol: Bertrand Routy, MD PhD, Centre hospitalier de l'Université de Montréal (CHUM)
- Studiestol: Houda Bahig, MD PhD, Centre hospitalier de l'Université de Montréal (CHUM)
Publikationer og nyttige links
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
- Neoplasmer efter sted
- Neoplasmer
- Luftvejssygdomme
- Lungesygdomme
- Neoplasmer i luftvejene
- Thoracale neoplasmer
- Lungeneoplasmer
- Karcinom, bronkogent
- Bronkiale neoplasmer
- Karcinom, ikke-småcellet lunge
- Sundhedstjenester Administration
- Sundhedsvæsenets kvalitet, adgang og evaluering
- Sundhedskvalitet
- Kvalitetsindikatorer, sundhedsvæsenet
- Standard for pleje
Andre undersøgelses-id-numre
- 2021-9066
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
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