Neoplasms

All Conditions

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Gland and Hormone Related Diseases

Symptoms and General Pathology

Rare Diseases

Carcinoma

Ovarian Neoplasms

Carcinoma, Ovarian Epithelial

Recurrence

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Endocrine Gland Neoplasms

Ovarian Diseases

Adnexal Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Genital Neoplasms, Female

Urogenital Neoplasms

Endocrine System Diseases

Gonadal Disorders

Ovarian Cancer

Ovarian Epithelial Cancer

Fallopian Tube Cancer

Antineoplastic Agents

All Drugs and Chemicals

Paclitaxel

Albumin-Bound Paclitaxel

Cisplatin

Tubulin Modulators

Antimitotic Agents

Paclitaxel group are treated with weekly paclitaxel and oncothermia for 4-cycles.

Cisplatin group are treated with weekly cisplatin and oncothermia for 4-cycles.

Patients are treated with weekly paclitaxel 70mg/m2 (IV) on day 1, 8, and 15 at an intervals of 4 weeks

weekly paclitaxel

Patients are treated with weekly cisplatin 40mg/m2 (IV) on day 1, 8, and 15 at an intervals of 4 weeks.

weekly cisplatin

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.

oncothermia

Kidong kim, MD

Kidong Kim

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.

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.

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

When limiting toxicity occur in the rate equal to or more than two of six assessable patients, study would be closed.

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).

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).

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).

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 (%)

Seoul National University Hospital

Professor

Respiratory Tract (Lung and Bronchial) Diseases

Behaviors and Mental Disorders

Carcinoma, Non-Small-Cell Lung

Lung Neoplasms

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Carcinoma, Bronchogenic

Bronchial Neoplasms

Quality of Life

Micronutrients

Vitamins

Ascorbic Acid

Trace Elements

Antioxidants

Protective Agents

Vitamin C

Patients will be allocated into 3 Vitamin C infusion dosage groups:

1g/kg.d,1.2g/kg.d,1.5g/kg.d;3 times a week for 8 weeks(25 infusions);concurrent with Modulated Electro-Hyperthermia (mEHT): 150W x 60 min/session,3 times a week for 8 weeks (25 sessions);together with supportive care.

Supportive care focuses on helping patients get relief from symptoms such as nausea, pain, fatigue, or shortness of breath,etc.

Vitamin C infusion, as an alternative anticancer therapy, has been used for many years. In the last 10 years, an increasing number of studies have indicated that VitC in pharmacological concentration can selectively kill cancer cells. Phase I clinical trial showed that VitC(1.5g/kg, 90-120mins, 3 times a week) infusion is safe without significant adverse reactions. A phase II clinical trial indicated that large dose of vitC infusion can reduce toxic side effects from chemo drugs when it was used synergy with chemotherapy.

vitamin C

MEHT is a descendant of hyperthermia initially based on nano-thermal but not temperature-dependent effects of electromagnetic fields and special fractal modulation, whose effect could 3-4 times exceed the effect of the overall heating (macroscopic temperature elevation). MEHT does not require hyperthermia-range temperatures and could be performed safely without invasive thermal control. EHY-2000 local machine is used for mEHT in the trial.

Modulated Electro-Hyperthermia (mEHT)

Supportive care

Junwen Ou, PhD

This trial studies efficacy and safety of combination of vitamin C infusion with modulated electro-hyperthermia (mEHT) in treatment of non small cell lung cancer patients.Phase I of this clinical study is to find the tolerable dose and best schedule of the combination of vitamin C infusion and mEHT that can be given to patients with NSCLC. Phase II of this study is to learn if the combination of vitamin C infusion and mEHT can help to control NSCLC and improve quality of life.

Phase I and Phase II clinical trial indicated large dose of vitC infusion is safe and can reduce toxic side effects from chemo drugs when it was used synergy with chemotherapy. The new technology of modulated electro-hyperthermia (mEHT),trade name: oncothermia has been proven efficacy in lung cancer with minimal side effects.The investigators have accumulated some successful cases in the treatment of primary lung cancer by using vitamin C infusion in combination with oncothermia. One diagnosed with squamous cell lung cancer patient survive beyond 5 years only receiving intravenous vitamin C+ mEHT. Based on this, it is necessary to conduct an in-depth study to explore the best treatment protocol for NSCLC patients.

Safety and Efficacy of Vitamin C Infusion in Combination With Local mEHT to Treat Non Small Cell Lung Cancer

Phase I-II Study of Vitamin C Infusion in Combination With Local mEHT on Non Small Cell Lung Cancer Patients

Adverse events, whether volunteered by the study subject, discovered by the investigators during questioning, or detected by physical examination, laboratory tests, or other means will be collected and recorded at each visit. Events will be recorded from the time the consent is signed until 4 weeks after the study protocol is discontinued.

Tumor markers such as CEA,CYFRA21-1,CA153,SCC will be evaluated at baseline and one month after completion of treatment. Enhanced CT scan will be performed at baseline and one months after completion of treatment to measure the size of the tumor.

Clifford Hospital, Guangzhou, China

Digestive System Diseases

Pancreatic Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Pancreatic Diseases

Pancreatic Cancer

Gemcitabine

Folfirinox

Antimetabolites

Patients with oncothermia treatment and palliative chemotherapy

Patients with palliative chemotherapy only

Oncothermia is a kind of hyperthermia treatment. It serves heat energy more selectively than conventional hyperthermia.

Oncothermia

As a standard palliative chemotherapy, FOLFIRINOX or Gemcitabine based chemotherapy will be treated to the patients.

FOLFIRINOX or Gemcitabine based chemotherapy

Jin-Hyeok Hwang, MD PhD

Jaihwan Kim, MD

Patients with pancreatic cancer often suffer from pain. Because of such a pain, their quality of life have seriously deteriorated. There have been a few studies that showed an effect for pain control by hyperthermia (heating the patient's body). However, there are several limitations in conventional hyperthermia.

In a previous pilot study (NCT02150135), we found the improvement of quality of life, function, and symptom.

From this background, the investigators tried to show the effect of "Oncothermia" with conventional chemotherapy for pain control, increasing quality of life, and anti-tumor treatment.

Multicenter RCT of the Clinical Effectiveness of Oncothermia With Chemotherapy in Metastatic Pancreatic Cancer Patients

A Multicenter, Prospective, Randomized Clinical Trial of the Clinical Effectiveness of Oncothermia Combined With Standard Chemotherapy in Metastatic Pancreatic Cancer Patients

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
A Trial of Weekly Paclitaxel With Oncothermia and Weekly cisPlatin With Oncothermia in Patients With Recurrent or Persistent Ovarian Cancer	NCT02344095	Epithelial Ovar... Fallopian Tube ... Primary Periton...	weekly paclitax... weekly cisplati... oncothermia	-	Seoul National University Hospital
Safety and Efficacy of Vitamin C Infusion in Combination With Local mEHT to Treat Non Small Cell Lung Cancer	NCT02655913	Carcinoma, Non-... Stage IIIA Non-... Stage IIIB Non-... Stage IV Non-sm... Recurrent Non-s...	vitamin C Modulated Elect... Supportive care	18 Years - 70 Years	Clifford Hospital, Guangzhou, China
A Trial of Weekly Paclitaxel With Oncothermia and Weekly cisPlatin With Oncothermia in Patients With Recurrent or Persistent Ovarian Cancer	NCT02344095	Epithelial Ovar... Fallopian Tube ... Primary Periton...	weekly paclitax... weekly cisplati... oncothermia	-	Seoul National University Hospital
Safety and Efficacy of Vitamin C Infusion in Combination With Local mEHT to Treat Non Small Cell Lung Cancer	NCT02655913	Carcinoma, Non-... Stage IIIA Non-... Stage IIIB Non-... Stage IV Non-sm... Recurrent Non-s...	vitamin C Modulated Elect... Supportive care	18 Years - 70 Years	Clifford Hospital, Guangzhou, China
Multicenter RCT of the Clinical Effectiveness of Oncothermia With Chemotherapy in Metastatic Pancreatic Cancer Patients	NCT02862015	Cancer, Pancrea...	Oncothermia FOLFIRINOX or G...	20 Years -	Seoul National University Hospital

Spots Global Cancer Trial Database for oncothermia

Every month we try and update this database with for oncothermia cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for oncothermia

Every month we try and update this database with for oncothermia cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for oncothermia cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.