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

Not Applicable

Active, not recruiting

• Conditions: Neoplasms

• Registration Number: KCT0002772
• Lead Sponsor: CC Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 11 March 2019

Recruitment & Eligibility

• Status: Active, not recruiting
• Sex: Female
• Target Recruitment: 19

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

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

Study & Design

• Study Type: Interventional Study
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
To assess toxicity and feasibility of the oncothermia therapy.