Clinical trial · Interventional
A Trial of Weekly Paclitaxel With Oncothermia and Weekly cisPlatin With Oncothermia in Patients With Recurrent or Persistent Ovarian Cancer
A Randomized Phase 1 Trial Evaluating the Safety of Weekly Paclitaxel With Oncothermia and Weekly cisPlatin With Oncothermia in Patients With Recurrent or Persistent Epithelial Ovarian, Fallopian Tube or Primary Peritoneal Carcinoma
- 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)
The investigators aimed to evaluate the safety of weekly paclitaxel with oncothermia and weekly cisplatin with oncothermia in patients with recurrent or persistent epithelial ovarian, fallopian tube or primary peritoneal carcinoma. This trial is a randomized phase 1 trial. The investigators planned to perform it for 1 year. In this trial, a total of 12 patients with recurrent or persistent epithelial ovarian, fallopian tube or primary peritoneal carcinoma are randomly assigned to either a paclitaxel or cisplatin group in ratio of 1 to 1. Paclitaxel group are treated with weekly paclitaxel and oncothermia. Cisplatin group are treated with weekly cisplatin and oncothermia. In each group, limiting toxicity is evaluated after treating 3 patients for 4-cycles. Primary endpoint is occurrence of limiting toxicity. Secondary endpoints are response rate, progression-free survival, overall-survival, quality of life, pain, fatigue and compliance rate.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Epithelial Ovarian Carcinoma | — | UNRESOLVED | — |
| Fallopian Tube Carcinoma | Fallopian Tube Carcinoma | ONTOLOGY_EXACT | 0.98 |
| Primary Peritoneal Carcinoma | Primary Peritoneal Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| oncothermia | Device | — | UNRESOLVED |
| weekly cisplatin | Drug | Cisplatin | ALIAS |
| weekly paclitaxel | Drug | Paclitaxel | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- weekly paclitaxel with oncothermia
- description
- Paclitaxel group are treated with weekly paclitaxel and oncothermia for 4-cycles.
- interventionNames
- Drug: weekly paclitaxel
- Device: oncothermia
- type
- EXPERIMENTAL
- label
- weekly cisplatin with oncothermia
- description
- Cisplatin group are treated with weekly cisplatin and oncothermia for 4-cycles.
- interventionNames
- Drug: weekly cisplatin
- Device: oncothermia
Primary outcomes (1)
- measure
- Occurrence of limiting toxicity
Eligibility
Eligibility (as posted)
- Sex
- Female
Show eligibility criteria text
Inclusion Criteria: * Recurrent or persistent epithelial ovarian, fallopian tube or primary peritoneal carcinoma (At the first diagnosis, pathologic findings should be confirmed.) * Response assessments that are possible by using radiologic tests or tumor markers * The number of chemotherapeutic regimens that were previously used ≤ 2 * Adequate hematologic, hepatic, and renal functions * ECOG performance status 0 - 2 Exclusion Criteria: * Recurrent or persistent epithelial ovarian, fallopian tube or primary peritoneal carcinoma that are located on the part of body where it is impossible to deliver energy by using oncothermia (EHY 2000) probe * Neurotoxicity ≥ grade 2 * Pacemaker user * Large metal materials such as artificial joint that are kept in the body * Recurrent or persistent epithelial ovarian, fallopian tube or primary peritoneal carcinoma that are located on the part of body where got previously radiation therapy
References
Publications (1)
- DERIVEDKim K, Kim JH, Kim SC, Kim YB, Nam BH, No JH, Cho H, Ju W, Suh DH, Kim YH. Modulated electro-hyperthermia with weekly paclitaxel or cisplatin in patients with recurrent or persistent epithelial ovarian, fallopian tube or primary peritoneal carcinoma: The KGOG 3030 trial. Exp Ther Med. 2021 Jul;22(1):787. doi: 10.3892/etm.2021.10219. Epub 2021 May 21. PMID 34055086