Symptoms and General Pathology

All Conditions

Wounds and Injuries

Neoplasms

Digestive System Diseases

Ascites

Hyperthermia

Fever

Peritoneal Neoplasms

Yin Deficiency

Yang Deficiency

Abdominal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Peritoneal Diseases

Antineoplastic Agents

All Drugs and Chemicals

Fluorouracil

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.

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.

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)

Shi Pi Decoction can warm Yang, invigorate the spleen, promote Qi circulation to induce diuresis and treat Foot-Taiyin meridian in Gu Zhang.

TCM Herbal Decoction (Shi Pi)

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

IPCI (CDDP+5FU)

Clifford LK Pang, PhD

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).

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).

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

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

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.

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.

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%.

Galenic Research Institute Ltd

The adverse events were accounted based on the objective data and voluntary testimonies of patients or through non-leading questions, and were timely recorded into the "Table of Adverse Events".

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.

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.

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.

Study 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.

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

Control Group

Total

Age, Continuous

Sex: Female, Male

China

Region of Enrollment

Gastric Cancer

Colon Cancer

Rectal Cancer

Pancreatic Cancer

Endometrial Cancer

Ovarian Cancer

Liver Cancer

Primary Disease

Lungs

Liver

Celiac lymph nodes

Bones

Metastases

Peritoneal carcinomatosis itself is considered III stage; evidence of distant metastases means IV stage.

Stage

KPS 90% - symptomatic patients with normal daily activity. KPS 80% - normal daily activity with effort. KPS 70% - limited daily activity (unable to work), complete self-care. KPS 60% - limited daily activity (unable to work), limited self-care (needs assistance), active \>50% of daytime.

KPS \<60% (Perforce inactive (sits or lies) ≥50% of daytime) excluded.

Karnofsky Performance Score

CDDP (Intraperitoneal Chemoinfusion) Dose Per Session

5-FU (Intraperitoneal Chemoinfusion) Dose Per Session

mEHT

IPCI

Interventions

* Absence of the detailed peritoneal carcinomatosis characteristics.
* Absence of a survival analysis. These limitations are related to the restricted funding of the trial.

Prof. Clifford LK Pang, President of Clifford Hospital

Applies to "Objective Response Rate (ORR)"

Objective Response Rate (ORR)

Applies to "Damage of hepatic or renal function"

Abdominal pain (Gr. I)

Gastrointestinal Reactions (Gr. I)

Damage of hepatic or renal function (Gr. I)

Bone marrow depression (Gr. I)

Adverse Events Rate (AER)

Better QoL (KPS IR)

No Change

Worse QoL

Quality of Life (QoL)

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 was occluded. Administered biweekly during four weeks of the course, totally two times.

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

Spots Global Cancer Trial Database for ipci (cddp+5fu)