Clinical trial · Interventional
Intraperitoneal Aerosol Chemotherapy in Gastric Cancer
Feasibility, Efficacy and Safety of Pressurized Intraperitoneal Aerosol Chemotherapy (PIPAC) With Cisplatin and Doxorubicin in Patients With Gastric Cancer and Peritoneal Carcinomatosis: an Open-label, Single-arm, Phase II Clinical Trial
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Gastric Cancer | Malignant Gastric Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| doxorubicin and cisplatin | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Intraperitoneal Chemotherapy
- description
- 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.
- interventionNames
- Drug: doxorubicin and cisplatin
Primary outcomes (1)
- measure
- Clinical Benefit Rate
- timeFrame
- within 3 months after treatment completion
- description
- Clinical Benefit Rate according to RECIST criteria after 3 cycles of PIPAC with cisplatin and doxorubicin.
Secondary outcomes (1)
- measure
- Observed Survival
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: * age above 18 years * written, informed consent * presence of peritoneal carcinomatosis Exclusion Criteria: * language barrier * parenchymal metastases * unability to undergo laparoscopy
References
Publications (1)
- RESULTStruller 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. PMID 31205501