Clinical trial · Interventional
Surgery Plus Intraoperative Peritoneal Hyperthermic Chemotherapy (IPHC) to Treat Peritoneal Carcinomatosis
Cytoreductive Surgery Plus Intraoperative Peritoneal Hyperthermic Chemotherapy for the Treatment of Peritoneal Carcinomatosis From Gastrointestinal Cancer: an Open Label, Randomized, Prospective, Phase 2 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)
OBJECTIVES: * Determine response and survival of patients with peritoneal carcinomatosis treated with cytoreductive surgery plus intraoperative peritoneal hyperthermic chemotherapy with cisplatin and mitomycin * Assess the quality of life of patients treated with this regimen. OUTLINE: Patients are randomized into IPHC group and control group. In the former group, the patients undergo cytoreductive surgery plus intraoperative hyperthermic peritoneal perfusion with cisplatin and mitomycin over 60 minutes. Patients in the control group just underwent routine cytoreductive surgery. All patients in both groups receive the standard conventional chemotherapy after surgery. Quality of life is assessed at study initiation, at 1, 3, 6 months. Patients are followed at 4 weeks, every 3 months for 1 year, and then every 6 months for up to 3 years.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colorectal Neoplasms | Colorectal Neoplasm | ONTOLOGY_EXACT | 0.98 |
| Mesothelioma | Malignant Mesothelioma | CURATED_EXACT | 0.92 |
| Neoplasm Metastasis | Peritoneal Neoplasm | PROBABILISTIC | 0.70 |
| Stomach Neoplasms | Gastric Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| cytoreductive surgery | Procedure | — | UNRESOLVED |
| intraoperative peritoneal hyperthermic chemotherapy with cisplatin and mitomycin | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- A
- description
- cytoreductive surgery, IPHC, cisplatin 20 mg/m2/L, Mitomycin C 4 mg/m2/L, postoperative chemotherapy.
- interventionNames
- Procedure: intraoperative peritoneal hyperthermic chemotherapy with cisplatin and mitomycin
- type
- ACTIVE_COMPARATOR
- label
- B
- description
- cytoreductive surgery alone, postoperative chemotherapy.
- interventionNames
- Procedure: cytoreductive surgery
Primary outcomes (1)
- measure
- overall survival time
- timeFrame
- from operation to death due to cancer recurrence
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 20 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: * Gastric cancer or colorectal cancer with peritoneal carcinomatosis * Gastric cancer or colorectal cancer with malignant ascites * Karnofsky Performance Scale(KPS)\>50 Exclusion Criteria: * Age less than 20 years old, or beyond 70 years old * Any lung metastasis, liver metastasis, or prominent retroperitoneal lymph node metastasis * Bilirubin greater than 3 times upper limit of normal (ULN) * AST and ALT greater than 5 times ULN * Liver enzymes greater than 3 times ULN
References
Publications (3)
- BACKGROUNDYang XJ, Li Y, al-shammaa Hassan AH, Yang GL, Liu SY, Lu YL, Zhang JW, Yonemura Y. Cytoreductive surgery plus hyperthermic intraperitoneal chemotherapy improves survival in selected patients with peritoneal carcinomatosis from abdominal and pelvic malignancies: results of 21 cases. Ann Surg Oncol. 2009 Feb;16(2):345-51. doi: 10.1245/s10434-008-0226-2. Epub 2008 Nov 19. PMID 19018599
- DERIVEDZou D, Cai Y, Jin M, Zhang M, Liu Y, Chen S, Yang S, Zhang H, Zhu X, Huang C, Zhu Y, Miao X, Wei Y, Yang X, Tian J. A genetic variant in the immune-related gene ERAP1 affects colorectal cancer prognosis. Chin Med J (Engl). 2024 Feb 20;137(4):431-440. doi: 10.1097/CM9.0000000000002845. Epub 2023 Sep 8. PMID 37690994
- DERIVEDWu HT, Yang XJ, Huang CQ, Sun JH, Ji ZH, Peng KW, Zhang Q, Li Y. Cytoreductive surgery plus hyperthermic intraperitoneal chemotherapy with lobaplatin and docetaxel improves survival for patients with peritoneal carcinomatosis from abdominal and pelvic malignancies. World J Surg Oncol. 2016 Sep 15;14(1):246. doi: 10.1186/s12957-016-1004-4. PMID 27633880