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NCT Number: NCT02638051

Local mEHT + TCM Versus Intraperitoneal Chemoinfusion in Treatment of Malignant Ascites: Phase II RCT

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).

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Key information

Conditions

Peritoneal Neoplasms Abdominal Neoplasms Ascites Digestive System Diseases Digestive System Neoplasms Neoplasms Neoplasms by Site Pathologic Processes Pathological Conditions, Signs and Symptoms Peritoneal Diseases Yang Deficiency Yin Deficiency

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Clifford Hospital

Guangzhou, Guangdong, 511495, China

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Modulated Electro-Hyperthermia (mEHT)

Device

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

TCM Herbal Decoction (Shi Pi)

Dietary Supplement

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

IPCI (CDDP+5FU)

Drug

Intraperitoneal chemoinfusion of CDDP (30-60 mg) and 5-fluorouracil (500-600 mg/sqm).

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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%.

Sponsors and collaborators

Lead sponsor

Galenic Research Institute Ltd

Other

Registry information

Official study title

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

Acronym: OTMA-RII

Important dates

Study start
2014
Primary completion
2014
Study completion
2015
First posted
Dec 22, 2015
Registry last updated
May 19, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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