- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT00182754
Octreotide in Treating Patients With Cancer-Related Malignant Ascites
An Exploratory, Randomized, Placebo-Controlled Trial of Depot Octreotide (Sandostatin LARDepot) for Symptomatic Ascites in Cancer Patients
RATIONALE: Octreotide may be an effective treatment for malignant ascites. It is not yet known whether octreotide is more effective than a placebo in treating malignant ascites.
PURPOSE: This randomized phase III trial is studying octreotide to see how well it works compared to placebo in treating patients with cancer-related malignant ascites.
Přehled studie
Postavení
Intervence / Léčba
Detailní popis
OBJECTIVES:
Primary
- Compare the efficacy of octreotide vs placebo, in terms of extending the time-to-paracentesis, in patients with cancer-related symptomatic malignant ascites.
Secondary
- Compare the number of paracenteses in patients treated with these drugs.
- Determine the toxicity of octreotide in these patients.
- Compare the quality of life of patients treated with these drugs.
OUTLINE: This is a randomized, double-blind, placebo-controlled, multicenter study. Patients are stratified according to anticipated ongoing chemotherapy (yes vs no), frequency of prior paracentesis (never vs other), and prior chemotherapy (never vs only first-line chemotherapy vs second-line chemotherapy vs other). Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients receive octreotide subcutaneously (SC) once on day 1.
- Arm II: Patients receive placebo SC once on day 1. In both arms, treatment with intramuscular octreotide or placebo repeats monthly for up to 2 years in the absence of unacceptable toxicity.
Quality of life is assessed at baseline, 2 weeks, and then monthly for up to 2 years during study treatment.
After completion of study treatment, patients are followed every 6 months for up to 2 years.
Typ studie
Zápis (Aktuální)
Fáze
- Fáze 3
Kontakty a umístění
Studijní místa
-
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Colorado
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Aurora, Colorado, Spojené státy, 80012
- Aurora Presbyterian Hospital
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Boulder, Colorado, Spojené státy, 80301-9019
- Boulder Community Hospital
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Colorado Springs, Colorado, Spojené státy, 80933
- Penrose Cancer Center at Penrose Hospital
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Denver, Colorado, Spojené státy, 80210
- Porter Adventist Hospital
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Denver, Colorado, Spojené státy, 80220
- Rose Medical Center
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Denver, Colorado, Spojené státy, 80218
- Presbyterian - St. Luke's Medical Center
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Denver, Colorado, Spojené státy, 80204
- St. Anthony Central Hospital
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Denver, Colorado, Spojené státy, 80218
- St. Joseph Hospital
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Denver, Colorado, Spojené státy, 80224-2522
- CCOP - Colorado Cancer Research Program
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Englewood, Colorado, Spojené státy, 80110
- Swedish Medical Center
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Grand Junction, Colorado, Spojené státy, 81502
- St. Mary's Regional Cancer Center at St. Mary's Hospital and Medical Center
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Greeley, Colorado, Spojené státy, 80631
- North Colorado Medical Center
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Lone Tree, Colorado, Spojené státy, 80124
- Sky Ridge Medical Center
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Longmont, Colorado, Spojené státy, 80501
- Hope Cancer Care Center at Longmont United Hospital
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Loveland, Colorado, Spojené státy, 80539
- McKee Medical Center
-
Pueblo, Colorado, Spojené státy, 81004
- St. Mary - Corwin Regional Medical Center
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Thornton, Colorado, Spojené státy, 80229
- North Suburban Medical Center
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Wheat Ridge, Colorado, Spojené státy, 80033
- Exempla Lutheran Medical Center
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Illinois
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Joliet, Illinois, Spojené státy, 60435
- Joliet Oncology-Hematology Associates, Limited - West
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Moline, Illinois, Spojené státy, 61265
-
Moline, Illinois, Spojené státy, 61265
- Trinity Cancer Center at Trinity Medical Center - 7th Street Campus
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Indiana
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Elkhart, Indiana, Spojené státy, 46515
- Elkhart General Hospital
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Kokomo, Indiana, Spojené státy, 46904
- Howard Community Hospital
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La Porte, Indiana, Spojené státy, 46350
- Center for Cancer Therapy at LaPorte Hospital and Health Services
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South Bend, Indiana, Spojené státy, 46601
- Memorial Hospital of South Bend
-
South Bend, Indiana, Spojené státy, 46601
- CCOP - Northern Indiana CR Consortium
-
South Bend, Indiana, Spojené státy, 46617
- Saint Joseph Regional Medical Center
-
South Bend, Indiana, Spojené státy, 46617
- South Bend Clinic
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Iowa
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Ames, Iowa, Spojené státy, 50010
- McFarland Clinic, PC
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Bettendorf, Iowa, Spojené státy, 52722
-
Des Moines, Iowa, Spojené státy, 50309
- CCOP - Iowa Oncology Research Association
-
Des Moines, Iowa, Spojené státy, 50309
- John Stoddard Cancer Center at Iowa Methodist Medical Center
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Des Moines, Iowa, Spojené státy, 50309
- Medical Oncology and Hematology Associates at John Stoddard Cancer Center
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Des Moines, Iowa, Spojené státy, 50314
- Medical Oncology and Hematology Associates at Mercy Cancer Center
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Des Moines, Iowa, Spojené státy, 50314
- Mercy Cancer Center at Mercy Medical Center - Des Moines
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Des Moines, Iowa, Spojené státy, 50316
- John Stoddard Cancer Center at Iowa Lutheran Hospital
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Des Moines, Iowa, Spojené státy, 50307
- Mercy Capitol Hospital
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Sioux City, Iowa, Spojené státy, 51101
- Siouxland Hematology-Oncology Associates, LLP
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Sioux City, Iowa, Spojené státy, 51104
- St. Luke's Regional Medical Center
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Sioux City, Iowa, Spojené státy, 51104
- Mercy Medical Center - Sioux City
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Kansas
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Chanute, Kansas, Spojené státy, 66720
- Cancer Center of Kansas, PA - Chanute
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Dodge City, Kansas, Spojené státy, 67801
- Cancer Center of Kansas, PA - Dodge City
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El Dorado, Kansas, Spojené státy, 67042
- Cancer Center of Kansas, PA - El Dorado
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Independence, Kansas, Spojené státy, 67301
- Cancer Center of Kansas-Independence
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Kingman, Kansas, Spojené státy, 67068
- Cancer Center of Kansas, PA - Kingman
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Lawrence, Kansas, Spojené státy, 66044
- Lawrence Memorial Hospital
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Liberal, Kansas, Spojené státy, 67901
- Southwest Medical Center
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Newton, Kansas, Spojené státy, 67114
- Cancer Center of Kansas, PA - Newton
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Parsons, Kansas, Spojené státy, 67357
- Cancer Center of Kansas, PA - Parsons
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Pratt, Kansas, Spojené státy, 67124
- Cancer Center of Kansas, PA - Pratt
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Salina, Kansas, Spojené státy, 67042
- Cancer Center of Kansas, PA - Salina
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Wellington, Kansas, Spojené státy, 67152
- Cancer Center of Kansas, PA - Wellington
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Wichita, Kansas, Spojené státy, 67208
- Cancer Center of Kansas, PA - Medical Arts Tower
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Wichita, Kansas, Spojené státy, 67214
- Cancer Center of Kansas, PA - Wichita
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Wichita, Kansas, Spojené státy, 67214
- CCOP - Wichita
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Wichita, Kansas, Spojené státy, 67214
- Via Christi Cancer Center at Via Christi Regional Medical Center
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Wichita, Kansas, Spojené státy, 67208
- Associates in Womens Health, PA - North Review
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Winfield, Kansas, Spojené státy, 67156
- Cancer Center of Kansas, PA - Winfield
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Michigan
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Adrian, Michigan, Spojené státy, 49221
- Hickman Cancer Center at Bixby Medical Center
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Lambertville, Michigan, Spojené státy, 48144
- Haematology-Oncology Associates of Ohio and Michigan, PC
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Monroe, Michigan, Spojené státy, 48162
- Community Cancer Center of Monroe
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Monroe, Michigan, Spojené státy, 48162
- Mercy Memorial Hospital - Monroe
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St. Joseph, Michigan, Spojené státy, 49085
- Lakeland Regional Cancer Care Center - St. Joseph
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Minnesota
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Alexandria, Minnesota, Spojené státy, 56308
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Bemidji, Minnesota, Spojené státy, 56601
- MeritCare Bemidji
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Duluth, Minnesota, Spojené státy, 55805
- CCOP - Duluth
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Duluth, Minnesota, Spojené státy, 55805-1983
- Duluth Clinic Cancer Center - Duluth
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Duluth, Minnesota, Spojené státy, 55805
- Miller - Dwan Medical Center
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Fergus Falls, Minnesota, Spojené státy, 56537
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Mankato, Minnesota, Spojené státy, 56002
- Immanuel St. Joseph's
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Rochester, Minnesota, Spojené státy, 55905
- Mayo Clinic Cancer Center
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Saint Cloud, Minnesota, Spojené státy, 56303
- CentraCare Clinic - River Campus
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Saint Cloud, Minnesota, Spojené státy, 56303
- Coborn Cancer Center
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Montana
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Billings, Montana, Spojené státy, 59101
- CCOP - Montana Cancer Consortium
-
Billings, Montana, Spojené státy, 59101
- Hematology-Oncology Centers of the Northern Rockies - Billings
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Billings, Montana, Spojené státy, 59101
- Northern Rockies Radiation Oncology Center
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Billings, Montana, Spojené státy, 59101
- St. Vincent Healthcare Cancer Care Services
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Billings, Montana, Spojené státy, 59107-7000
- Billings Clinic - Downtown
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Butte, Montana, Spojené státy, 59701
- St. James Healthcare Cancer Care
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Great Falls, Montana, Spojené státy, 59405
- Great Falls Clinic - Main Facility
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Great Falls, Montana, Spojené státy, 59405
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Havre, Montana, Spojené státy, 59501
- Northern Montana Hospital
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Helena, Montana, Spojené státy, 59601
- St. Peter's Hospital
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Kalispell, Montana, Spojené státy, 59901
- Kalispell Regional Medical Center
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Kalispell, Montana, Spojené státy, 59901
- Glacier Oncology, PLLC
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Kalispell, Montana, Spojené státy, 59901
- Kalispell Medical Oncology at KRMC
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Missoula, Montana, Spojené státy, 59801
- Community Medical Center
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Missoula, Montana, Spojené státy, 59804
- Guardian Oncology and Center for Wellness
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Missoula, Montana, Spojené státy, 59807-7877
- Montana Cancer Specialists at Montana Cancer Center
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Missoula, Montana, Spojené státy, 59807
- Montana Cancer Center at St. Patrick Hospital and Health Sciences Center
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Nebraska
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Omaha, Nebraska, Spojené státy, 68106
- CCOP - Missouri Valley Cancer Consortium
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Omaha, Nebraska, Spojené státy, 68122
- Immanuel Medical Center
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Omaha, Nebraska, Spojené státy, 68124
- Alegant Health Cancer Center at Bergan Mercy Medical Center
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Omaha, Nebraska, Spojené státy, 68131-2197
- Creighton University Medical Center
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North Dakota
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Bismarck, North Dakota, Spojené státy, 58501
- Bismarck Cancer Center
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Bismarck, North Dakota, Spojené státy, 58501
- Medcenter One Hospital Cancer Care Center
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Bismarck, North Dakota, Spojené státy, 58501
- Mid Dakota Clinic, PC
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Bismarck, North Dakota, Spojené státy, 58502
- St. Alexius Medical Center Cancer Center
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Fargo, North Dakota, Spojené státy, 58122
- CCOP - MeritCare Hospital
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Fargo, North Dakota, Spojené státy, 58122
- MeritCare Broadway
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Ohio
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Bowling Green, Ohio, Spojené státy, 43402
- Wood County Oncology Center
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Clyde, Ohio, Spojené státy, 43410
- North Coast Cancer Care - Clyde
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Elyria, Ohio, Spojené státy, 44035
- Hematology Oncology Center
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Lima, Ohio, Spojené státy, 45804
- Lima Memorial Hospital
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Maumee, Ohio, Spojené státy, 43537
- St. Luke's Hospital
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Maumee, Ohio, Spojené státy, 43537-1839
- Northwest Ohio Oncology Center
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Oregon, Ohio, Spojené státy, 43616
- St. Charles Mercy Hospital
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Oregon, Ohio, Spojené státy, 43616
- Toledo Clinic - Oregon
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Sandusky, Ohio, Spojené státy, 44870
- North Coast Cancer Care, Incorporated
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Sylvania, Ohio, Spojené státy, 43560
- Flower Hospital Cancer Center
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Tiffin, Ohio, Spojené státy, 44883
- Mercy Hospital of Tiffin
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Toledo, Ohio, Spojené státy, 43608
- St. Vincent Mercy Medical Center
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Toledo, Ohio, Spojené státy, 43606
- Toledo Hospital
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Toledo, Ohio, Spojené státy, 43614
- Medical University of Ohio Cancer Center
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Toledo, Ohio, Spojené státy, 43617
- CCOP - Toledo Community Hospital
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Toledo, Ohio, Spojené státy, 43623
- Toledo Clinic, Incorporated - Main Clinic
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Toledo, Ohio, Spojené státy, 43623
- St. Anne Mercy Hospital
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Wauseon, Ohio, Spojené státy, 43567
- Fulton County Health Center
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South Dakota
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Sioux Falls, South Dakota, Spojené státy, 57105
- Avera Cancer Institute
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Sioux Falls, South Dakota, Spojené státy, 57105
- Medical X-Ray Center, PC
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Sioux Falls, South Dakota, Spojené státy, 57117-5039
- Sanford Cancer Center at Sanford USD Medical Center
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Virginia
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Richmond, Virginia, Spojené státy, 23298-0037
- Virginia Commonwealth University Massey Cancer Center
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Popis
DISEASE CHARACTERISTICS:
- Histologically or cytologically confirmed cancer
Diagnosis of malignant ascites, as determined by the treating oncologist
- Positive cytology not required
- Patient is symptomatic and views ascites as a problem
- No lymphoma or lymphomatous ascites
- Planning therapeutic paracentesis ≤ 3 days after study entry OR completed therapeutic paracentesis 2 days before study entry
PATIENT CHARACTERISTICS:
Age
- 18 and over
Performance status
- Not specified
Life expectancy
- At least 4 weeks
Hematopoietic
- Not at high risk of bleeding from a procedure
Hepatic
- No known cirrhosis or portal hypertension
Renal
- No known history of chronic renal failure, defined as creatinine ≥ 2 times upper limit of normal
Other
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- Prior cholecystitis allowed provided patient underwent cholecystectomy
- No uncontrolled diabetes mellitus
- No known allergy to octreotide
- No known allergy to latex
- No medical condition that would preclude study treatment
PRIOR CONCURRENT THERAPY:
Biologic therapy
- No concurrent bevacizumab
Chemotherapy
- No concurrent intraperitoneal chemotherapy
No concurrent first-line chemotherapy for any cancer except pancreatic cancer
- Concurrent second-line chemotherapy or later-line chemotherapy allowed
Endocrine therapy
- No other concurrent octreotide
Radiotherapy
- Not specified
Surgery
- Not specified
Other
No concurrent therapeutic warfarin
- Concurrent prophylactic warfarin at a dose of 1 mg/day allowed
- No other concurrent treatment for ascites except paracentesis or ongoing diuretics
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Dvojnásobek
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
---|---|
Experimentální: Arm I
Patients receive octreotide subcutaneously (SC) once on day 1.
|
Given subcutaneously
|
Komparátor placeba: Arm II
Patients receive placebo SC once on day 1.
|
Podáno subkutánně
|
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
---|---|---|
Median Time to Paracentesis
Časové okno: Up to 2 years
|
Kaplan Meier curves will be constructed for each group; patients lost to follow up will be censored.
A log rank test will be used to compare groups.
We will adjust for the volume of fluid withdrawn at paracentesis and for change in abdominal circumference between baseline and the next procedure because a patient may require an extra paracentesis if only a small volume is withdrawn at baseline.
|
Up to 2 years
|
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
---|---|---|
Number of Paracenteses
Časové okno: Up to 2 years
|
We will compare the number of paracenteses between groups.
Parametric or nonparametric testing will be used as appropriate.
|
Up to 2 years
|
Average Quality-of-life
Časové okno: Up to 2 years
|
Quality of life will be recorded and analyzed in a descriptive, exploratory fashion.
We acknowledge that this study will represent the first to attempt a prospective assessment of quality of life in patients with symptomatic ascites.
The underlying hypothesis of this quality of life assessment is that patients who are receiving octreotide will enjoy a better quality of life compared to patients who receive placebo.
Quality of life scores from the CLDQ will be summed for all patients on a monthly basis.
Again we anticipate high patient drop out rates over time within these two cohorts.
With due diligence, we will attempt to ascertain the reason for each patient drop out, and appropriate imputation techniques will be employed for each.Quantified as: 1='All of the time' 2='Most of the time' 3='A good bit of the time' 4='Some of the time' 5='A little bit of the time' 6='Hardly any of the time' 7='None of the time' 0='Missing';
|
Up to 2 years
|
Spolupracovníci a vyšetřovatelé
Spolupracovníci
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia
Primární dokončení (Aktuální)
Dokončení studie (Aktuální)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Odhad)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
Další identifikační čísla studie
- NCCTG-N04C2
- NCI-2009-00647 (Identifikátor registru: CTRP (Clinical Trials Reporting System))
- CDR0000440922 (Identifikátor registru: PDQ (Physician Data Query))
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