Ascites Clinical Trial
— OTMA-RIIOfficial 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
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).
Status | Completed |
Enrollment | 260 |
Est. completion date | December 2015 |
Est. primary completion date | December 2014 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 75 Years |
Eligibility |
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. |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
China | Clifford Hospital | Guangzhou | Guangdong |
Lead Sponsor | Collaborator |
---|---|
Galenic Research Institute Ltd |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Objective Reaponse Rate (ORR) | Complete Remission and Partial Remission (CR + PR) | 8 weeks after start of treatment (4 weeks on completion of treatment) | No |
Secondary | Adverse Events Rate (AER) | During 4 weeks of treatment course and 4 weeks after treatment | Yes | |
Secondary | Quality of Life (QoL) | Karnofsky Performance Score Improvement Rate (KPS IR) | 8 weeks after start of treatment (4 weeks on completion of treatment) | No |
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