Clinical trial · Interventional
Surgery and Chemotherapy With or Without Chemotherapy After Surgery in Treating Patients With Ovarian, Fallopian Tube, Uterine, or Peritoneal Cancer
Cytoreductive Surgery With Hyperthermic Intraperitoneal Chemotherapy (HIPEC) and Optional Postoperative Normothermic Intraperitoneal (IP) Chemotherapy to Treat Primary or Recurrent Carcinoma of Ovarian, Fallopian Tube, Uterine, or Peritoneal Origin
- 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)
This phase I trial studies the side effects and how well surgery and heated chemotherapy with or without non-heated chemotherapy after surgery works in treating patients with ovarian, fallopian tube, uterine, or peritoneal cancer. Giving a dose of heated chemotherapy into the abdomen during surgery that is done to remove ovarian, fallopian tube, uterine, or peritoneal cancer may help lower the risk of the cancer coming back. Giving unheated chemotherapy drugs directly into the abdomen after surgery may kill more tumor cells.
Conditions
Conditions (29)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| FIGO Stage IVA Ovarian Cancer | — | UNRESOLVED | — |
| FIGO Stage IVB Ovarian Cancer | — | UNRESOLVED | — |
| Platinum-Resistant Ovarian Carcinoma | Platinum-Resistant Ovarian Carcinoma | ONTOLOGY_EXACT | 0.98 |
| Recurrent Fallopian Tube Carcinoma | Fallopian Tube Carcinoma | CURATED_BROADER | 0.78 |
| Recurrent Ovarian Carcinoma | Ovarian Carcinoma | CURATED_BROADER | 0.78 |
| Recurrent Primary Peritoneal Carcinoma | Primary Peritoneal Carcinoma | CURATED_BROADER | 0.78 |
| Recurrent Uterine Corpus Carcinoma | — | UNRESOLVED | — |
Interventions
Interventions (8)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Carboplatin | Drug | Carboplatin | ALIAS |
| Cisplatin | Drug | Cisplatin | ALIAS |
| Gemcitabine Hydrochloride | Drug | Gemcitabine | ALIAS |
| Laboratory Biomarker Analysis | Other | — | UNRESOLVED |
| Paclitaxel | Drug | Paclitaxel | ALIAS |
| Pegylated Liposomal Doxorubicin Hydrochloride | Drug | Doxorubicin | ALIAS |
| Quality-of-Life Assessment | Other | — | UNRESOLVED |
| Therapeutic Conventional Surgery | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Treatment (surgery, HIPEC cisplatin)
- description
- Patients undergo surgery and receive hyperthermic cisplatin IP over 60 minutes. Beginning at least 3 weeks after surgery, patients may receive carboplatin, paclitaxel, pegylated liposomal doxorubicin hydrochloride, or gemcitabine hydrochloride IP or IV at the discretion of the medical and gynecologic oncologists.
- interventionNames
- Drug: Carboplatin
- Drug: Cisplatin
- Drug: Gemcitabine Hydrochloride
- Other: Laboratory Biomarker Analysis
- Drug: Paclitaxel
- Drug: Pegylated Liposomal Doxorubicin Hydrochloride
- Other: Quality-of-Life Assessment
- Procedure: Therapeutic Conventional Surgery
Primary outcomes (1)
- measure
- Incidence of treatment-related toxicities according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) guidelines
- timeFrame
- Up to 3 months post-surgery
- description
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Provided informed consent * Patient with primary or recurrent International Federation of Gynecology and Obstetrics (FIGO) stage III or IV, or recurrent ovarian, fallopian tube, peritoneal carcinoma, or uterine cancer, confined to abdominal cavity, including those who have completed neoadjuvant chemotherapy and primary surgery * Gynecologic Oncology Group (GOG) or Eastern Cooperative Oncology Group (ECOG) performance status =\< 1 or Karnofsky scale (KPS) \>= 70% * Patients who are platinum-sensitive or platinum resistant * Candidate for potentially radical, maximal effort cytoreductive surgery at the discretion and expertise of the treating physician * For patients with newly diagnosed-ovarian/tubal/peritoneal cancer who have received pre-operative neoadjuvant chemotherapy, evidence of response must be documented by at least one of the following: * Decline in serum cancer antigen (CA) 125 level * At least a 30% decrease in the sum of the longest diameter of target lesions on radiographic imaging * Improvement of ascites volume * Neoadjuvant chemotherapy must be held for at least 3 weeks prior to surgery * Resolution of any effects of prior therapy (except alopecia and peripheral neuropathy) to the current National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) grade =\< 1 and to baseline laboratory values as defined * Hemoglobin (HGB) \>= 9 g/dL * White blood cell (WBC) \>= 3,000/mcL * Absolute neutrophil count (ANC) \>= 1,500/mcL * Platelets (PLT) \>= 100,000/mcL * Total bilirubin within normal institutional limits * Serum glutamic oxaloacetic transaminase (SGOT)/serum glutamate pyruvate transaminase (SGPT) \< 2.5 x institutional upper limit of normal (ULN) * Creatinine \< 1.5 x ULN or creatinine clearance \> 60 ml/min according to Cockcroft-Gault formula * Neuropathy (sensory and motor) NCI CTCAE grade =\< 2 * Prothrombin time (PT) such that international normalized ratio (INR) is \< 1.5 (or an in-range INR, usually between 2 and 3, if a patient is on a stable dose of therapeutic warfarin or low molecular weight heparin) and a partial thromboplastin time (PTT) \< 1.2 times control * Serum albumin \>= 2.5 * No active infection requiring antibiotics * Preoperative or intraoperative (frozen section) diagnosis of ovarian, peritoneal, fallopian tubal or uterine cancer * Surgery achieves either no gross residual disease (R0) or optimal cytoreductive status defined as no single lesion measuring more than 5.0 mm in its greatest diameter * Stable from a cardiopulmonary standpoint to continue with prolonged surgery and anesthesia Exclusion Criteria: * Patients with active extra-abdominal disease including active malignant pleural effusion; patients who have been successfully treated with neoadjuvant chemotherapy and no longer have (malignant) pleural effusions may be included * Patients whose disease has progressed following at least 3 cycles of neoadjuvant chemotherapy as defined by at least one of the following: * Doubling of serum CA-125 level * At least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since the treatment started or the appearance of one or more new lesions * Clinical deterioration (worsening ascites, carcinomatous ileus, malignant bowel obstruction, severe hypoalbuminemia, declining performance status) * Cardiac or pulmonary conditions that preclude aggressive cytoreductive surgery * Patients whose circumstances do not permit completion of the study or the required follow-up * Pregnant, nursing, or of childbearing potential and refuse hysterectomy or bilateral salpingo-oophorectomy * Other active invasive malignancies, with the exception of non-melanoma skin cancer and breast cancer (if without evidence of disease 1 year after completion of treatment) * Metastatic non-gynecologic or breast primaries * Sub-optimal resection as their surgical outcome * Intraoperative frozen section suggesting hepatobiliary, pancreatic, adrenal, or urinary tract cancer
References
Publications (1)
- DERIVEDDellinger TH, Han ES, Raoof M, Lee B, Wu X, Cho H, He TF, Lee P, Razavi M, Liang WS, Schmolze D, Priceman SJ, Lee S, Lin WC, Lin JF, Kebria M, Hakim A, Ruel N, Stewart DB, Wang EW, Paz BI, Wakabayashi MT, Cristea MC, Rodriguez-Rodriguez L. Hyperthermic Intraperitoneal Chemotherapy-Induced Molecular Changes in Humans Validate Preclinical Data in Ovarian Cancer. JCO Precis Oncol. 2022 Mar;6:e2100239. doi: 10.1200/PO.21.00239. PMID 35357903