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

• Sponsor: Galenic Research Institute Ltd (Other)
• Overall Status: Completed
• CT.gov ID: NCT02638051
• Collaborator: (none)
• Enrollment: 260
• Location: 1
• Arms: 2
• Duration (Months): 23
• Patients Per Site Per Month: 11.3

Study Details

Study Description

Brief Summary

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).

Condition or Disease	Intervention/Treatment	Phase
Peritoneal Neoplasms; Ascites; Yang Deficiency; Yin Deficiency	Device: Modulated Electro-Hyperthermia (mEHT); Dietary Supplement: TCM Herbal Decoction (Shi Pi); Drug: IPCI (CDDP+5FU)	Phase 2

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 Design

• Study Type: Interventional
• Actual Enrollment: 260 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official 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
• Study Start Date: Jan 1, 2014
• Actual Primary Completion Date: Dec 1, 2014
• Actual Study Completion Date: Dec 1, 2015

Arms and Interventions

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).

Outcome Measures

Primary Outcome Measures

1. Objective Response Rate (ORR) [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 Outcome Measures

1. Adverse Events Rate (AER) [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) [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%.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Clifford Hospital	Guangzhou	Guangdong	China	511495

Sponsors and Collaborators

• Galenic Research Institute Ltd

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

• Andocs G, Meggyeshazi N, Balogh L, Spisak S, Maros ME, Balla P, Kiszner G, Teleki I, Kovago C, Krenacs T. Upregulation of heat shock proteins and the promotion of damage-associated molecular pattern signals in a colorectal cancer model by modulated electrohyperthermia. Cell Stress Chaperones. 2015 Jan;20(1):37-46. doi: 10.1007/s12192-014-0523-6. Epub 2014 Jun 29.
• Andocs G, Renner H, Balogh L, Fonyad L, Jakab C, Szasz A. Strong synergy of heat and modulated electromagnetic field in tumor cell killing. Strahlenther Onkol. 2009 Feb;185(2):120-6. doi: 10.1007/s00066-009-1903-1. Epub 2009 Feb 25.
• Ling Y. Traditional Chinese medicine in the treatment of symptoms in patients with advanced cancer. Ann Palliat Med. 2013 Jul;2(3):141-52. doi: 10.3978/j.issn.2224-5820.2013.04.05.
• Matharu G, Tucker O, Alderson D. Systematic review of intraperitoneal chemotherapy for gastric cancer. Br J Surg. 2011 Sep;98(9):1225-35. doi: 10.1002/bjs.7586. Epub 2011 Jun 6. Review.
• Meggyeshazi N, Andocs G, Balogh L, Balla P, Kiszner G, Teleki I, Jeney A, Krenacs T. DNA fragmentation and caspase-independent programmed cell death by modulated electrohyperthermia. Strahlenther Onkol. 2014 Sep;190(9):815-22. doi: 10.1007/s00066-014-0617-1. Epub 2014 Feb 22.
• Sangisetty SL, Miner TJ. Malignant ascites: A review of prognostic factors, pathophysiology and therapeutic measures. World J Gastrointest Surg. 2012 Apr 27;4(4):87-95. doi: 10.4240/wjgs.v4.i4.87.
• Tsang YW, Huang CC, Yang KL, Chi MS, Chiang HC, Wang YS, Andocs G, Szasz A, Li WT, Chi KH. Improving immunological tumor microenvironment using electro-hyperthermia followed by dendritic cell immunotherapy. BMC Cancer. 2015 Oct 15;15:708. doi: 10.1186/s12885-015-1690-2.

• Responsible Party: Galenic Research Institute Ltd
• ClinicalTrials.gov Identifier: NCT02638051
• Other Study ID Numbers: OT-CH-PCMA-14
• First Posted: Dec 22, 2015
• Last Update Posted: May 19, 2017
• Last Verified: Dec 1, 2015

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Keywords provided by Galenic Research Institute Ltd: Peritoneal Carcinomatosis; Malignant Ascites; Modulated Electro-Hyperthermia; Traditional Chinese Medicine
• Additional relevant MeSH terms: Peritoneal Neoplasms; Ascites; Yin Deficiency; Yang Deficiency

Study Results

Participant Flow

Recruitment Details	From January 3, 2014 to December 20, 2014, 260 patients were recruited in Clifford Hospital. They were randomly allocated in two groups with 130 patients in each group.
Pre-assignment Detail	There was no any pre-assignment dropout or exclusion.

Arm/Group Title	Study Group	Control Group
Arm/Group Description	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.	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).
Period Title: Overall Study
STARTED	130	130
COMPLETED	130	130
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	Study Group	Control Group	Total
Arm/Group Description	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.	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).	Total of all reporting groups
Overall Participants	130	130	260
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	58.88 (12.43)	56.07 (15.38)	57.48 (14.03)
Sex: Female, Male (Count of Participants)
Female	72 55.4%	61 46.9%	133 51.2%
Male	58 44.6%	69 53.1%	127 48.8%
Region of Enrollment (participants) [Number]
China	130 100%	130 100%	260 100%
Primary Disease (participants) [Number]
Gastric Cancer	22 16.9%	24 18.5%	46 17.7%
Colon Cancer	34 26.2%	37 28.5%	71 27.3%
Rectal Cancer	18 13.8%	15 11.5%	33 12.7%
Pancreatic Cancer	13 10%	8 6.2%	21 8.1%
Endometrial Cancer	9 6.9%	5 3.8%	14 5.4%
Ovarian Cancer	11 8.5%	16 12.3%	27 10.4%
Liver Cancer	23 17.7%	25 19.2%	48 18.5%
Metastases (participants) [Number]
Lungs	23 17.7%	20 15.4%	43 16.5%
Liver	32 24.6%	35 26.9%	67 25.8%
Celiac lymph nodes	53 40.8%	50 38.5%	103 39.6%
Bones	22 16.9%	25 19.2%	47 18.1%
Stage (participants) [Number]
I	0 0%	0 0%	0 0%
II	0 0%	0 0%	0 0%
III	66 50.8%	76 58.5%	142 54.6%
IV	64 49.2%	54 41.5%	118 45.4%
Karnofsky Performance Score (participants) [Number]
60	26 20%	21 16.2%	47 18.1%
70	50 38.5%	47 36.2%	97 37.3%
80	42 32.3%	48 36.9%	90 34.6%
90	12 9.2%	14 10.8%	26 10%
CDDP (Intraperitoneal Chemoinfusion) Dose Per Session (mg) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [mg]	0 (0)	49.63 (10.19)	NA (NA)
5-FU (Intraperitoneal Chemoinfusion) Dose Per Session (mg/sqm) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [mg/sqm]	0 (0)	548.5 (39.68)	NA (NA)
Interventions (sessions) [Median (Full Range) ]
mEHT	14	0	NA
TCM	28	0	NA
IPCI	0	2	NA

Outcome Measures

1. Primary Outcome

Title	Objective Response Rate (ORR)
Description	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.
Time Frame	8 weeks after start of treatment (4 weeks on completion of treatment)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Study Group	Control Group
Arm/Group Description	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.	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).
Measure Participants	130	130
Number [percentage of participants]	77.7 59.8%	63.8 49.1%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Study Group, Control Group
	Comments	Applies to "Objective Response Rate (ORR)"
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.0140
	Comments
	Method	Chi-squared
	Comments

2. Secondary Outcome

Title	Adverse Events Rate (AER)
Description	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.
Time Frame	During 4 weeks of treatment course and 4 weeks after treatment

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Study Group	Control Group
Arm/Group Description	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.	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).
Measure Participants	130	130
All	3 2.3%	16 12.3%
Abdominal pain (Gr. I)	3 2.3%	5 3.8%
Gastrointestinal Reactions (Gr. I)	0 0%	3 2.3%
Damage of hepatic or renal function (Gr. I)	0 0%	2 1.5%
Bone marrow depression (Gr. I)	0 0%	6 4.6%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Study Group, Control Group
	Comments	Applies to "All" Adverse Events rate
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.0016
	Comments
	Method	Chi-squared
	Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Study Group, Control Group
	Comments	Applies to "Abdominal pain" rate
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	>0.05
	Comments
	Method	Chi-squared
	Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Study Group, Control Group
	Comments	Applies to "Gastrointestinal reactions"
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	>0.05
	Comments
	Method	Chi-squared
	Comments

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Study Group, Control Group
	Comments	Applies to "Damage of hepatic or renal function"
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	>0.05
	Comments
	Method	Chi-squared
	Comments

Statistical Analysis 5

Statistical Analysis Overview	Comparison Group Selection	Study Group, Control Group
	Comments	Applies to "Bone marrow depression"
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.0215
	Comments
	Method	Chi-squared
	Comments

3. Secondary Outcome

Title	Quality of Life (QoL)
Description	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%.
Time Frame	8 weeks after start of treatment (4 weeks on completion of treatment)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Study Group	Control Group
Arm/Group Description	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.	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).
Measure Participants	130	130
Better QoL (KPS IR)	49.2 37.8%	32.3 24.8%
No Change	40.8 31.4%	52.3 40.2%
Worse QoL	10 7.7%	15.4 11.8%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Study Group, Control Group
	Comments	Applies to "Better QoL"
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.0053
	Comments
	Method	Chi-squared
	Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Study Group, Control Group
	Comments	Applies to "No Change"
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.0527
	Comments
	Method	Chi-squared
	Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Study Group, Control Group
	Comments	Applies to "Worse QoL"
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	>0.05
	Comments
	Method	Chi-squared
	Comments

Adverse Events

Time Frame	2 months
Adverse Event Reporting Description	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".
Arm/Group Title	Study Group		Control Group
Arm/Group Description	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.		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).
All Cause Mortality
	Study Group		Control Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Study Group		Control Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/130 (0%)		0/130 (0%)
Other (Not Including Serious) Adverse Events
	Study Group		Control Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	3/130 (2.3%)		16/130 (12.3%)
Blood and lymphatic system disorders
Bone marow depression	0/130 (0%)	0	6/130 (4.6%)	6
Gastrointestinal disorders
Abdominal Pain	3/130 (2.3%)	3	5/130 (3.8%)	5
Gastrointestinal Reactions	0/130 (0%)	0	3/130 (2.3%)	3
Hepatobiliary disorders
Damage of hepatic function	0/130 (0%)	0	1/130 (0.8%)	1
Renal and urinary disorders
Damage of renal function	0/130 (0%)	0	1/130 (0.8%)	1

Limitations/Caveats

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

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.