Local mEHT + TCM Versus Intraperitoneal Chemoinfusion in Treatment of Malignant Ascites: Phase II RCT (OTMA-RII)

April 15, 2017 updated by: Galenic Research Institute Ltd

Local Modulated Electro-Hyperthermia in Combination With Traditional Chinese Medicine Versus Intraperitoneal Chemoinfusion in Treatment of Peritoneal Carcinomatosis With Malignant Ascites: A Phase II Randomized Trial

This trial studies efficacy and safety of combination of modulated electro-hyperthermia (mEHT) with Traditional Chinese Medicine (TCM) in treatment of peritoneal carcinomatosis with malignant ascites versus standard chemoinfusion (CDDP+5FU).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Conservative treatment of peritoneal carcinomatosis with malignant ascites (PCMA) is based on chemoinfusion with its inherent toxicity. There is a strong demand for a safe and non-toxic method of treatment of PCMA. The new technology of modulated electro-hyperthermia (mEHT) has proven efficacy in many advanced cancers with minimal side effects and synergy with Traditional Chinese Medicine (TCM). TCM has a long history of application at advanced cancer as a symptomatic treatment and enhancer of the general resistance of the organism. Shi Pi Decoction is supposed to be the optimum co-treatment of PCMA according to principles of TCM. Intraperitoneal chemoinfusion (IPCI) with cisplatin and fluorouracil is a widespread standard treatment of PCMA in China. This randomized II phase trial studies efficacy and safety of combination of mEHT with TCM in treatment of PCMA versus standard IPCI (CDDP+5FU).

Study Type

Interventional

Enrollment (Actual)

260

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 511495
        • Clifford Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 73 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Pathologically confirmed PC with malignant ascites.
  • Karnofsky Performance Status (KPS) score ≥60%.
  • Normal function of bone marrow.
  • Predicted survival time >1 month.
  • Written informed consent.

Exclusion Criteria:

  • Surgery within 3 weeks or not full recovery of postoperative suture.
  • Active bleeding or vascular occlusion in the mEHT treatment area.
  • Emotional instability.
  • Impossibility to place the patient into the mEHT machine.
  • Metallic implants or replacements in the treatment area.
  • Electronic implanted devices anywhere.
  • Missing or damaged heat-sense nerves or other field-sensitive issues in the treatment area.
  • Very low white blood cell count (<1.5×10(9)/L), agranulocytosis (<0.5×10(9)/L) or severe anemia.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Study Group
Modulated Electro-Hyperthermia (mEHT): 150 Watt x 60 min/session every 2nd day for 4 weeks (14 sessions); TCM Herbal Decoction: Shi Pi Decoction administered orally twice a day (200 mL x 2) 30 min after breakfast and supper, for 4 weeks.
Device: Modulated Electro-Hyperthermia (mEHT)
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.
Other Names:
  • Oncothermia
Dietary supplement: TCM Herbal Decoction (Shi Pi)
Shi Pi Decoction can warm Yang, invigorate the spleen, promote Qi circulation to induce diuresis and treat Foot-Taiyin meridian in Gu Zhang.
Other Names:
  • Shi Pi Decoction
Active Comparator: Control Group
IPCI: CDDP (30-60 mg) with 5FU (500-600 mg/sqm of body surface), both dissolved in 100 mL of normal saline, after abdominal paracentesis and catheterization with following closed drainage of the ascites up to small amount of remaining liquid. After IPCI, the catheter occluded. Administered biweekly during four weeks of the course, totally two times.
Drug: IPCI (CDDP+5FU)
Intraperitoneal chemoinfusion of CDDP (30-60 mg) and 5-fluorouracil (500-600 mg/sqm).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Objective Response Rate (ORR)
Time Frame: 8 weeks after start of treatment (4 weeks on completion of treatment)

Objective Response Rate (ORR) = Complete Remission (CR) + Partial Remission (PR)

WHO criteria of therapeutic effect evaluation at malignant ascites:

  • Complete Remission (CR): complete absorption of ascites with no obvious regeneration for more than 1 month.
  • Partial Remission (PR): more than 50% reduction of ascites, with obvious relief of abdominal distention, with maintenance of less than moderate volume of ascites under ultrasound detection for more than 1 month.
  • No Change (NC): less than 50% reduction of ascites, or no obvious reduction of ascites under ultrasound detection, or even increase of ascites, with obvious abdominal distention.
8 weeks after start of treatment (4 weeks on completion of treatment)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adverse Events Rate (AER)
Time Frame: During 4 weeks of treatment course and 4 weeks after treatment
Common Terminology Criteria for Adverse Events (CTCAE) (v4.03: June 14, 2010) U.S.DEPARTMENT OF HEALTH AND HUMAN SERVICES, National Institutes of Health, National Cancer Institute.
During 4 weeks of treatment course and 4 weeks after treatment
Quality of Life (QoL)
Time Frame: 8 weeks after start of treatment (4 weeks on completion of treatment)

Karnofsky Performance Score Improvement Rate (KPS IR)

  • Improvement: increase of KPS for ≥10% after treatment.
  • Worsening: reduction of KPS for ≥10% after treatment.
  • NC: change of KPS for <10%.
8 weeks after start of treatment (4 weeks on completion of treatment)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Galenic Research Institute Ltd

Investigators

  • Principal Investigator: Clifford LK Pang, PhD, Clifford Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2014

Primary Completion (Actual)

December 1, 2014

Study Completion (Actual)

December 1, 2015

Study Registration Dates

First Submitted

December 17, 2015

First Submitted That Met QC Criteria

December 18, 2015

First Posted (Estimate)

December 22, 2015

Study Record Updates

Last Update Posted (Actual)

May 19, 2017

Last Update Submitted That Met QC Criteria

April 15, 2017

Last Verified

December 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OT-CH-PCMA-14

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Study Data/Documents

  1. Clinical Study Report
    Information identifier: 10.3892/mco.2017.1221
    Information comments: Pang CLK, Zhang X, Wang Z, Ou J, Lu Y, Chen P, Zhao C, Wang X, Zhang H, Roussakow SV. Local modulated electro-hyperthermia in combination with traditional Chinese medicine vs. intraperitoneal chemoinfusion for the treatment of peritoneal carcinomatosis with malignant ascites: A phase II randomized trial. Mol Clin Oncol. 2017;6:723-32,

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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