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A prospective series of patients with recurrent gastric cancer will be treated with three cycles of chemotherapy (doxorubicin and cisplatin) instilled into the abdominal cavity in the form of an aerosol under pressure via laparoscopy. The efficacy of this treatment will be assessed by computed tomography, tumor marker studies, and survival. Also, the safety of the procedure will be assessed.
Objectives: To evaluate the safety and efficacy in terms of the clinical benefit rate (CBR) of PIPAC in peritoneal carcinomatosis (PC) from gastric cancer (GC) Study design: Single center, open label, non-randomized, single-arm, repeated single dose study to explore the efficacy, safety, and CBR of doxorubicin and cisplatin when given as a pressurized intraperitoneal aerosol chemotherapy (PIPAC) to patients with advanced gastric cancer and peritoneal carcinomatosis.
Target subject population:Patients with GC and PC with disease progression after at least one line of previous i.v. chemotherapy.
Investigational product, dosage and mode of administration Doxorubicin 1.5 mg/m2 body surface in 50 ml NaCl 0,9% and Cisplatin 7.5 mg/m2 in 50 ml NaCl 0,9% q 4-6 weeks, applied intraperitoneally as PIPAC.
Duration of treatment: 3 single doses in 6 weeks intervals, duration of treatment is 18 weeks
Outcome variables:
1.1 Primary outcome variable • Clinical Benefit Rate (CBR) according to Response Evaluation Criteria In Solid Tumors (RECIST) criteria (version 1.1) after 3 cycles of PIPAC with cisplatin and doxorubicin.
1.2 Secondary outcome variables
1.5 Biological monitoring
• Basic research investigating expression of genes associated with drug resistance.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intraperitoneal Chemotherapy | Experimental | Patients will receive doxorubicin 1.5 mg/m2 body surface in 50 ml NaCl 0,9% and cisplatin 7.5 mg/m2 in 50 ml NaCl 0,9% q 4-6 weeks, applied intraperitoneally as pressurized aerosol chemotherapy. Duration of treatment will be 3 single doses in 6 weeks intervals, thus the duration of treatment is 18 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| doxorubicin and cisplatin | Drug | doxorubicin and cisplatin as intraperitoneal chemotherapy |
|
| Measure | Description | Time Frame |
|---|---|---|
| Clinical Benefit Rate | Clinical Benefit Rate according to RECIST criteria after 3 cycles of PIPAC with cisplatin and doxorubicin. | within 3 months after treatment completion |
| Measure | Description | Time Frame |
|---|---|---|
| Observed Survival | Survival will be assessed by direct observation during treatment and by follow-up investigation for 1 year after completion of the study | During treatment and follow-up of 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| median time ot progression | Time to progression according to RECIST criteria during treatment and during follow-up of 1 year | during treatment and follow-up of 1 year |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Marc A Reymond, MD | Ruhr University of Bochum | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ruhr University of Bochum | Herne | North Rhine-Westphalia | 44625 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31205501 | Result | Struller F, Horvath P, Solass W, Weinreich FJ, Strumberg D, Kokkalis MK, Fischer I, Meisner C, Konigsrainer A, Reymond MA. Pressurized intraperitoneal aerosol chemotherapy with low-dose cisplatin and doxorubicin (PIPAC C/D) in patients with gastric cancer and peritoneal metastasis: a phase II study. Ther Adv Med Oncol. 2019 May 13;11:1758835919846402. doi: 10.1177/1758835919846402. eCollection 2019. |
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| ID | Term |
|---|---|
| D013274 | Stomach Neoplasms |
| D009369 | Neoplasms |
| ID | Term |
|---|---|
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| D004317 | Doxorubicin |
| D002945 | Cisplatin |
| ID | Term |
|---|---|
| D003630 | Daunorubicin |
| D018943 | Anthracyclines |
| D009279 | Naphthacenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
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| D005767 | Gastrointestinal Diseases |
| D013272 | Stomach Diseases |
| D006841 |
| Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D011083 | Polycyclic Compounds |
| D000617 | Aminoglycosides |
| D006027 | Glycosides |
| D002241 | Carbohydrates |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017672 | Nitrogen Compounds |
| D017671 | Platinum Compounds |