- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT03862768
Role of Surgery in Patients With Focally Progressive Gastrointestinal Stromal Tumors (GISTs) After Imatinib Treatment
1. marts 2019 opdateret af: Shanghai Zhongshan Hospital
Role of Surgery in Patients With Focally Progressive Gastrointestinal Stromal Tumors (GISTs) After Imatinib Treatment: A Prospective, Multicenter, Randomized Trial
This study evaluates the efficacy and safety of surgical intervention in patients with focally progressive GISTs after imatinib treatment.
The enrolled patients will be randomized to receive surgery following imatinib 400 milligram per day (MG/d) or only tyrosine kinase inhibitor (Imatinib 600 MG/d or Sunitinib 37.5 MG/d).
Studieoversigt
Status
Ukendt
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
Imatinib is the first-line treatment for advanced GIST with a satisfactory response rate, but complete remission rarely happens.
Besides, drug resistance can occur during the treatment and the median time of drug resistance is about 20-24 months.
Once drug resistance occurs, the patient's condition will progress rapidly.
As a salvage treatment, the effect of increasing the dose of imatinib or switching to sunitinib is very limited.
Progress after imatinib treatment usually involves two conditions, focal progression and extensive progression.
For local progression, all resistant lesions can be completely resected; extensive progression refers to resistance progression in multiple sites, and progressive lesions cannot be completely removed.
The present study is aimed to assess the benefits of surgical resection of imatinib-resistant lesions in patients with localized disease.
Undersøgelsestype
Interventionel
Tilmelding (Forventet)
92
Fase
- Ikke anvendelig
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
18 år til 75 år (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inclusion Criteria:
- Patients whose pathology is clearly diagnosed as recurrent/metastatic GIST, have undergone standardized imatinib treatment, and the disease progresses during the treatment;
- The lesions with progress are confined to one organ, and the number is ≤3; after evaluation by relevant professional surgeons or multidisciplinary team discussion, it is considered that the progressive lesions can be completely and safely removed without affecting the organ function;
- Age: 18 years old ≤ age ≤ 75 years old;
- No other malignant tumors occurred within five years;
- Eastern Cooperative Oncology Group (ECOG) physical status score <2 points;
- American Society of Anesthesiologists (ASA) score <3 points;
- There are no restrictions on gender and race;
- Patients with informed consent.
Exclusion Criteria:
- The patient has other serious comorbidities and cannot tolerate surgery: such as severe cardiopulmonary disease, cardiac function in grade 2 or lower, pulmonary infection, moderate to severe chronic obstructive pulmonary disease (COPD), etc., combined with severe diabetes and/or kidney Insufficient function, combined with severe hepatitis and/or functional Child-pugh grade C or a grade B that is clearly difficult to correct, combined with severe malnutrition;
- Patients with extensive disease progress;
- Imatinib primary resistant patients;
- Patients with other diseases requiring simultaneous surgical intervention, such as gallstones; inguinal hernia;
- Disease-related complications such as bleeding, perforation, and obstruction;
- Pregnant or lactating women;
- The patient has a serious mental illness;
- Patients with other malignant tumors within five years;
- The patient has participated in or is participating in other clinical studies or is using other tyrosinekinase inhibitors.
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: Surgery following imatinib
Surgery requires at least removal of all drug-resistant lesions.
Imatinib 400 MG/d should be taken once the patients resume oral diet.
|
Surgery requires at least removal of all drug-resistant lesions.
Imatinib 400 MG/d should be taken once the patients resume oral diet
|
|
Aktiv komparator: Imatinib escalation or sunitinib
Escalation of imatinib or replacement of sunitinib are both conventional salvage treatments for imatinib-resistant GISTs.
There is no high-level evidence to suggest which method is better.
So patients are free to choose imatinib 600 MG/d or sunitinib 37.5 MG/d
|
Imatinib 600 MG/d
Sunitinib 37.5 MG/d
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Progression-free Survival
Tidsramme: one year
|
Progression-free survival will be defined as time from the start of treatment until progression (documented according to Response Evaluation Criteria in Solid Tumors (RECIST) criteria and defined as at least a 20% increase in the sum of the longest diameter of target lesions) or death, whichever comes first.
|
one year
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Overall Survival
Tidsramme: one year
|
Overall survival will be defined as time from the start of treatment until death from any cause
|
one year
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Forventet)
1. juli 2019
Primær færdiggørelse (Forventet)
1. juni 2021
Studieafslutning (Forventet)
1. december 2021
Datoer for studieregistrering
Først indsendt
27. februar 2019
Først indsendt, der opfyldte QC-kriterier
1. marts 2019
Først opslået (Faktiske)
5. marts 2019
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
5. marts 2019
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
1. marts 2019
Sidst verificeret
1. februar 2019
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
- Sygdomme i fordøjelsessystemet
- Neoplasmer, bindevæv og blødt væv
- Neoplasmer efter histologisk type
- Neoplasmer
- Gastrointestinale neoplasmer
- Neoplasmer i fordøjelsessystemet
- Gastrointestinale sygdomme
- Neoplasmer, bindevæv
- Gastrointestinale stromale tumorer
- Lægemidlers fysiologiske virkninger
- Molekylære mekanismer for farmakologisk virkning
- Enzymhæmmere
- Antineoplastiske midler
- Angiogenese-hæmmere
- Angiogenesemodulerende midler
- Vækststoffer
- Væksthæmmere
- Proteinkinasehæmmere
- Sunitinib
- Imatinib mesylat
Andre undersøgelses-id-numre
- B2018-297
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
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