Randomized Controlled Trial to Prevent Peritoneal Seeding in Gastric Cancer (HIPECStomach)
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Inskrivning (Faktisk)
Fas
- Fas 2
- Fas 3
Kontakter och platser
Studieorter
-
-
BW
-
Tuebingen, BW, Tyskland, 72076
- University of Tuebingen
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
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
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: positive cytology with HIPEC
gastric cancer cytology positive with HIPEC Mytomycin and cisplatin intraoperative
|
HIPEC with mytomycin and cisplatin
Andra namn:
|
|
Inget ingripande: positive cytology without HIPEC
gastric cancer cytology positive without HIPEC
|
|
|
Inget ingripande: negative cytology without HIPEC
gastric cancer with negative cytology
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Peritoneal Carcinosis Free Survival
Tidsram: 5 Years
|
Three patients were enrolled in the study.
No study results because no patient has received study drug.
|
5 Years
|
|
Disease Free Survival
Tidsram: 5 years
|
No study results because no patient has received study drug.
|
5 years
|
Andra resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Procedure Related Complication
Tidsram: 60 days
|
No study results because no patient has received study drug.
|
60 days
|
|
Kinetics of Mitomycin and Cisplatin
Tidsram: 24 hours after application
|
24 hours after application
|
Samarbetspartners och utredare
Sponsor
Utredare
- Huvudutredare: Alfred Königsrainer, MD, University Hospital Tuebingen
Studieavstämningsdatum
Studera stora datum
Studiestart
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
- Matsmältningssystemets sjukdomar
- Neoplasmer efter histologisk typ
- Neoplasmer
- Neoplasmer efter plats
- Neoplasmer, körtel och epitel
- Peritoneala sjukdomar
- Gastrointestinala neoplasmer
- Neoplasmer i matsmältningssystemet
- Gastrointestinala sjukdomar
- Magsjukdomar
- Neoplasmer i buken
- Neoplasmer i magen
- Carcinom
- Peritoneala neoplasmer
- Antineoplastiska medel
- Cisplatin
Andra studie-ID-nummer
- 2011-004405-25
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
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