Randomized Controlled Trial to Prevent Peritoneal Seeding in Gastric Cancer (HIPECStomach)
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
The gastric carcinoma is one of the four most common tumors occurring worldwide. The advanced phase is characterized by metastasis and poses a very poor prognosis for survival. In 20%-30% of gastric carcinomas the tumor spreads into the abdominal cavity, which leads to metastases in the wall of the peritoneal cavity. This is known as peritoneal carcinomatosis and its five-year survival rate is less than 2%. Even after R0 resection of a localized gastric carcinoma the five-year survival rate is only 40%, not least of all because relapses in the form of peritoneal metastases are a common occurrence.
Patients with gastric carcinoma and not yet diagnosed with metastases, but who show free tumor cells in cytology in preoperative laparoscopy before neoadjuvant chemotherapy and gastrectomy, have an 80% risk of developing peritoneal carcinomatosis within one year, which stands in strong contrast to the 40% risk for patients with negative cytology.
In the study presented here (group A) therapeutic hyperthermic intraperitoneal chemoperfusion (HIPEC, in the literature also known as HIIC (heated intraoperative intraperitoneal chemotherapy) or IPHC (intraperitoneal chemohyperthermia)) with mitomycin c and cisplatin will be administered following gastrectomy in patients with a gastric carcinoma with free tumor cells in cytology diagnosed in the preoperative laparoscopy in comparison to (group B) solely gastrectomy in patients with a gastric carcinoma and also with free tumor cells diagnosed in cytology in the preoperative laparoscopy.
A randomization will be performed between group A and B. Patients with gastric carcinoma (TNM Stage ≥ T2<T4) without proven metastases (TNM stage M0), with and without involved regional lymph nodes (TNM stage +N/-N) and positive cytology in preoperative abdominal lavage will be included. Exclusion criteria are extended disease or inoperable tumor.
This study is already permitted by the local ethic commission and the German Federal Institute for Drugs and Medical Devices (BfArM) (EudraCT-Nr.: 2011-004405-25 / Study code: HIPEC_Stomach) and was initiated in August 2012.
Studietype
Registrering (Faktiske)
Fase
- Fase 2
- Fase 3
Kontakter og plasseringer
Studiesteder
-
-
BW
-
Tuebingen, BW, Tyskland, 72076
- University of Tuebingen
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
Inclusion Criteria:
- Histologically proven gastric adenocarcinoma: uT1,uT2, uT3, Nx, M0
- No prior chemotherapy
- Patients of full age, independent of gender ECOG ≤ 2
- No dissemination of the tumor confirmed by CT of the lung and the abdomen.
- Signed Consent form of the Patient agreeing to investigations
- Leucocytes > 3.000/µl
- Thrombocytes > 100.000/µl
- Creatinine ≤ 1.5mg/dl and or Clearance > 60 ml/min
- informed consent of the patient
- normal ejection-fraction of the heart
Exclusion Criteria:
- Dissemination of the tumor or non-resectable primary tumor
- Malignant secondary disease < 5 years in the past (Exception: in-situ-carcinoma of the cervix and appropriately treated basal cell carcinoma of the skin)
- Patient not of full age
- Inflammatory chronic bowel disease
- Inclusion of the patient in a different study
- Pregnancy or lactation
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: positive cytology with HIPEC
gastric cancer cytology positive with HIPEC Mytomycin and cisplatin intraoperative
|
HIPEC with mytomycin and cisplatin
Andre navn:
|
|
Ingen inngripen: positive cytology without HIPEC
gastric cancer cytology positive without HIPEC
|
|
|
Ingen inngripen: negative cytology without HIPEC
gastric cancer with negative cytology
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Peritoneal Carcinosis Free Survival
Tidsramme: 5 Years
|
Three patients were enrolled in the study.
No study results because no patient has received study drug.
|
5 Years
|
|
Disease Free Survival
Tidsramme: 5 years
|
No study results because no patient has received study drug.
|
5 years
|
Andre resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Procedure Related Complication
Tidsramme: 60 days
|
No study results because no patient has received study drug.
|
60 days
|
|
Kinetics of Mitomycin and Cisplatin
Tidsramme: 24 hours after application
|
24 hours after application
|
Samarbeidspartnere og etterforskere
Sponsor
Etterforskere
- Hovedetterforsker: Alfred Königsrainer, MD, University Hospital Tuebingen
Studierekorddatoer
Studer hoveddatoer
Studiestart
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
- Sykdommer i fordøyelsessystemet
- Neoplasmer etter histologisk type
- Neoplasmer
- Neoplasmer etter nettsted
- Neoplasmer, kjertel og epitel
- Peritoneale sykdommer
- Gastrointestinale neoplasmer
- Neoplasmer i fordøyelsessystemet
- Gastrointestinale sykdommer
- Magesykdommer
- Abdominale neoplasmer
- Neoplasmer i magen
- Karsinom
- Peritoneale neoplasmer
- Antineoplastiske midler
- Cisplatin
Andre studie-ID-numre
- 2011-004405-25
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
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