Clinical trial · Observational
Trial of Cytoreductive Surgery and HIPEC in Patients With Primary and Secondary Peritoneal Cancers
Trial of Cytoreductive Surgery and Hyperthermic Intraperitoneal Chemotherapy (HIPEC) in Patients With Primary Peritoneal Cancers and Secondary Peritoneal Cancers From Stomach, Colorectal, Appendiceal, and/or Gynecological Origins
- 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)
Patients with primary peritoneal cancer or secondary peritoneal cancers from stomach, colorectal, appendiceal, and gynecological primary origin will be screened by pathology and staging to see if they are eligible to undergo cytoreductive surgery combined with hyperthermic intraperitoneal chemotherapy (HIPEC). To be eligible for the study, patients must be over 18 years of age, have appropriate pathology and stage with disease confined to the peritoneal cavity, have a good performance status, have laboratory values that fall within safe ranges to undergo an operation and receive intraperitoneal chemotherapy. The chemotherapeutic agent and dose will be assigned based on pathological diagnosis in accordance with current standard of care. Surgery will be performed with the goal of removing all visible tumor that may require removal of adjacent organs. Once only microscopic disease is present, the chemotherapy will be delivered directly into the peritoneum via intraperitoneal hyperthermia and perfusion device. This will continue for 90 minutes. Patients will be followed for tumor response, survival, toxicity, complications, quality of life, and tumor markers. They will have regular follow up visits with the surgeon, undergo routine surveillance imagings, and receive follow up phone calls periodically.
Conditions
Conditions (8)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Appendiceal Cancer | Malignant Appendix Neoplasm | ALIAS | 0.90 |
| Cervical Cancer | Malignant Cervical Neoplasm | CURATED_EXACT | 0.92 |
| Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
| Fallopian Tube Cancer | Malignant Fallopian Tube Neoplasm | ALIAS | 0.90 |
| Ovarian Cancer | Malignant Ovarian Neoplasm | CURATED_EXACT | 0.92 |
| Primary Peritoneal Carcinoma | Primary Peritoneal Carcinoma | ONTOLOGY_EXACT | 0.98 |
| Stomach Cancer | Malignant Gastric Neoplasm | CURATED_EXACT | 0.92 |
| Uterine Cancer |
Interventions
Interventions (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| CDDP 50 | Drug | Cisplatin | ALIAS |
| CDDP 75 | Drug | Cisplatin | ALIAS |
| Doxorubicin | Drug | Doxorubicin | ALIAS |
| HIPEC | Device | — | UNRESOLVED |
| Mitomycin c | Drug | Mitomycin | ALIAS |
Design
Arms and outcomes
Arms (4)
- label
- Stomach
- description
- Heated Intraperitoneal Chemotherapy with Mitomycin C 30mg at time 0, 10mg at time 45 minutes, CDDP Cisplatin 50mg/m2@ time 0
- interventionNames
- Device: HIPEC
- Drug: Mitomycin c
- Drug: CDDP 50
- label
- Colorectal, Appendiceal, Pseudomyxoma Peritonei
- description
- Heated Intraperitoneal Chemotherapy with Mitomycin C 30mg at time 0, 10mg at time 45 minutes
- interventionNames
- Device: HIPEC
- Drug: Mitomycin c
- label
- Primary Peritoneal
- description
- Heated Intraperitoneal Chemotherapy with CDDP Cisplatin 50mg/m2 at time 0, Doxorubicin 15mg/m2 at time 0
- interventionNames
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: Age \>18 Diagnosis at the time of resection or on frozen section of: * recurrent or primary stomach, colorectal or appendiceal cancer with regional spread that is confined to the peritoneal cavity * primary peritoneal cancer * ovarian cancer stage IC or higher * uterine or cervical cancer stage IIA or higher with recurrence confined to the peritoneum * fallopian tube cancer stage III or recurrence confined to the peritoneum ECOG performance status of 0,1, or 2 Lab values: * absolute neutrophil count \>1500 * platelets \>100,000 * creatinine less than or equal to 2.0mg/dL * bilirubin less than or equal to 1.5 times the upper limit of normal * SGOT and alkaline phosphatase less than or equal to 2.5 times the upper limit of normal * patients of childbearing age must have a negative serum pregnancy test and be using an effective form of contraception Exclusion Criteria: * Extra-peritoneal disease or unresectable disease * Any known sensitivity to the chemotherapeutic agents used in the study * Significant medical comorbidities that would prevent the patient from being able to complete the protocol (at discretion of investigator) * Patients with gynecological malignancy who desire future fertility * An informed consent cannot be obtained from the patient or power of attorney
References
Publications (0)
Data not yet available