A Trial of Weekly Paclitaxel With Oncothermia and Weekly cisPlatin With Oncothermia in Patients With Recurrent or Persistent Ovarian Cancer

Study Overview
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Brief Summary
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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.

Detailed Description
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This trial is a randomized phase 1 trial. We planned to perform it for 1 year. Subjects of study are patients diagnosed as recurrent or persistent epithelial ovarian, fallopian tube or primary peritoneal carcinoma. The number of subjects of study is 12 patients (If patients cannot be assessed, they can be replaced with new patients). All subjects who were randomly assigned, are treated with weekly paclitaxel or weekly cisplatin. In paclitaxel group, patients are treated with weekly paclitaxel 70mg/m2 (IV) on day 1, 8, and 15 at an intervals of 4 weeks. In cisplatin group, 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. It takes 60 minutes to treat a site for oncothermia. Energy is gradually increased from 60W to 140W. With tumors at multiple sites, oncothermia is performed several times changing sites that apply probe and type of probes. Oncothermia is performed for 60 minutes per each application. 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. In group that limiting toxicity occur in the rate equal to or less than 1 patient, limiting toxicity is evaluated after treating 3 additional patients for 4-cycles. When limiting toxicity occur in the rate equal to or less than one of six assessable patients, it is considered that the specific therapy is safe enough to be used in phase 2 trial. Primary endpoint is occurrence of limiting toxicity. Secondary endpoints are response rate, progression-free survival, overall-survival, quality of life, toxicity, pain, fatigue and compliance rate. Patients visit twice a week until 4-cycles are completed or progression of disease is confirmed.

Official Title
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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

Conditions
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Epithelial Ovarian Carcinoma, Fallopian Tube Carcinoma, Primary Peritoneal Carcinoma

Intervention / Treatment
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* Drug: weekly paclitaxel
* Drug: weekly cisplatin
* Device: oncothermia


Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: weekly paclitaxel with oncothermia<br>Paclitaxel group are treated with weekly paclitaxel and oncothermia for 4-cycles. | Drug: weekly paclitaxel<br>* Patients are treated with weekly paclitaxel 70mg/m2 (IV) on day 1, 8, and 15 at an intervals of 4 weeks<br>Device: oncothermia<br>* 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.<br>|
| Experimental: weekly cisplatin with oncothermia<br>Cisplatin group are treated with weekly cisplatin and oncothermia for 4-cycles. | Drug: weekly cisplatin<br>* Patients are treated with weekly cisplatin 40mg/m2 (IV) on day 1, 8, and 15 at an intervals of 4 weeks.<br>Device: oncothermia<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| response rate | 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 | 
| progression-free survival | 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 | 
| overall-survival | 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 | 
| quality of life, assessed with the Korean version of WHO Quality of Life-BREF (WHOQOL-BREF). | When limiting toxicity occur in the rate equal to or more than two of six assessable patients, study would be closed. Quality of life would be 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). | When limiting toxicity occur in the rate equal to or more than two of six assessable patients, study would be closed. Pain would be assessed with the Korean version of the brief pain inventory (BPI). | 8 cycles up to 1 year | 
| fatigue, assessed with the Korean version of the Brief Fatigue Inventory (BFI). | When limiting toxicity occur in the rate equal to or more than two of six assessable patients, study would be closed. Fatigue would be assessed with the Korean version of the Brief Fatigue Inventory (BFI). | 8 cycles up to 1 year | 
| compliance rate | When limiting toxicity occur in the rate equal to or more than two of six assessable patients, study would be closed. Compliance rate would be assessed with the number of patients that are dropped out from current clinical trial based on other reasons instead of disease. It would be recorded as compliance rate = the number of patients that are dropped out due to other reasons/the number of total patients · 100 (%) | 8 cycles up to 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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recurrent, persistent