: Prospectively Phase I/II Clinical Study of Relapsed, Refractive to standard treatment for Ovarian Malignancies by Oncothermia Therapy

Prospectively Phase I/II Clinical Study of Relapsed, Refractive to standard treatment for Ovarian Malignancies by Oncothermia Therapy

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

CRIS

Registry ID

KCT0002772

Enrollment

Registered

2018-04-03

Start date

2013-10-08

Completion date

Unknown

Last updated

2019-03-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Medical Device : 5. Investigational Plan 5.1 Setting and location Single institute, open label, phase I/II study, investigator-initiated study. 5.2 Agent 1) Oncothermia (Onco-Therm EHY 2000) 5.3 Dos

Eligibility

Sex/Gender

Female

Inclusion criteria

Inclusion criteria: ? 1)Ovarian cancer, tubal cancer, and primary peritoneal cancer recurrent or persistent disease meeting at least 1 of the following criteria 2)Age more than 18 years, less than 85 years 3)Eastern Cooperative Oncology Group (ECOG) performance status 0, 1, 2 4)At least 1 tumor lesion measuring 1 cm or more in greater dimension on the CT or elevated CA125 level more than 70 U/mL 5)At least 4 weeks from the effect of previous treatment. 6)Adequate hematologic (WBC count = 2,000/mm3, neutrophil count = 1,000/mm3, platelet count = 70,000/mm3), hepatic (bilirubin level = 1.5 x institutional normal level, AST, ALT = 3x institutional normal level), and renal (serum creatinine = 1.5 mg/dl ) function. 7)Informed consent from patient 8)Must be free of clinically active infection

Exclusion criteria

Exclusion criteria: 1)patients who are suitable candidates for curative treatment with surgery or chemotherapy with adequate medical condition 2)History of allergic reactions attributed to oncothermia used in the study. 3)Pregnant or nursing woman 4)Pacemaker or any implantated metal like central venous port device (at the ipsilateral side and/or closer as 10 cm to the metastatic site to be treated) 5)Previous treatment with any form of hyperthermic therapy 6)Symptomatic metastases in the central nerve system 7)A second primary malignancy 8)Disability to understand the nature of the study and give written consent 9)Patients having acute infections 10)Any reason deemed appropriated by the investigator

Design outcomes

Primary

Measure	Time frame
To determine the maximum tolerated dose (MTD) of oncothermia in patients with relapsed or refractive ovarian cancer	—

Secondary

Measure	Time frame
To assess toxicity and feasibility of the oncothermia therapy.	—

Countries

Korea, Republic of

Contacts

Public Contactpark yoon

NCC Hospital

parksang@ncc.re.kr+82-31-920-0852

Outcome results