A Trial of Weekly Paclitaxel With Oncothermia and Weekly cisPlatin With Oncothermia in Patients With Recurrent or Persistent Ovarian Cancer
POPOPO
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
1 other identifier
interventional
12
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1
Started Dec 2014
Typical duration for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 1, 2014
CompletedStudy Start
First participant enrolled
December 1, 2014
CompletedFirst Posted
Study publicly available on registry
January 22, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2017
CompletedJuly 12, 2024
July 1, 2024
2.8 years
November 1, 2014
July 10, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Occurrence of limiting toxicity
When limiting toxicity occur in the rate equal to or more than two of six assessable patients, study would be closed.
8 cycles up to 1 year
Secondary Outcomes (7)
response rate
8 cycles up to 1 year
progression-free survival
8 cycles up to 1 year
overall-survival
8 cycles up to 1 year
quality of life, assessed with the Korean version of WHO Quality of Life-BREF (WHOQOL-BREF).
8 cycles up to 1 year
pain, assessed with the Korean version of the brief pain inventory (BPI).
8 cycles up to 1 year
- +2 more secondary outcomes
Study Arms (2)
weekly paclitaxel with oncothermia
EXPERIMENTALPaclitaxel group are treated with weekly paclitaxel and oncothermia for 4-cycles.
weekly cisplatin with oncothermia
EXPERIMENTALCisplatin group are treated with weekly cisplatin and oncothermia for 4-cycles.
Interventions
Patients are treated with weekly paclitaxel 70mg/m2 (IV) on day 1, 8, and 15 at an intervals of 4 weeks
Patients are treated with weekly cisplatin 40mg/m2 (IV) on day 1, 8, and 15 at an intervals of 4 weeks.
Thermotherapy is performed by applying oncothermia (EHY 2000) probe on the part of body where tumor is located and delivering energy. It is performed on day 1, 4, 8, 11, 15, 18, 21, and 24 (8 times in total every cycle). Oncothermia can be performed a day earlier than scheduled day or a day later than scheduled day. With tumors at multiple sites, oncothermia is performed several times changing sites that apply probe and type of probes. \- It takes 60 minutes to treat a site for oncothermia. Energy is gradually increased from 60W to 140W.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, 463707, South Korea
Related Publications (1)
Kim 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: 34055086DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Kidong kim, MD
Seoul National University Bundang Hospital,Gyeongg-ido,Repub
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
November 1, 2014
First Posted
January 22, 2015
Study Start
December 1, 2014
Primary Completion
October 1, 2017
Study Completion
October 1, 2017
Last Updated
July 12, 2024
Record last verified: 2024-07