|
Home
Search
Study Topics
Glossary
|
![]() |
![]() |
|
![]() |
|
![]() |
|
![]() |
![]() |
![]() |
|
![]() |
![]() |
||||||||||||||||||||||||||||||||||||
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Received Date ICMJE | July 11, 2001 | ||||
| Last Updated Date | February 6, 2009 | ||||
| Start Date ICMJE | February 2000 | ||||
| Primary Completion Date | |||||
| Current Primary Outcome Measures ICMJE |
Disease-free survival at 6 or 12 months [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE |
Disease-free survival at 6 or 12 months | ||||
| Change History | Complete list of historical versions of study NCT00020059 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | |||||
| Original Secondary Outcome Measures ICMJE | |||||
| Descriptive Information | |||||
| Brief Title ICMJE | Continuous Hyperthermic Peritoneal Perfusion With Cisplatin Plus Intraperitoneal Paclitaxel and Fluorouracil Following Surgery in Treating Patients With Peritoneal Cancer | ||||
| Official Title ICMJE | Phase II Trial of Continuous Hyperthermic Peritoneal Perfusion (CHPP) With Cisplatin Plus Early Postoperative Intraperitoneal Paclitaxel and 5-Fluorouracil for Peritoneal Carcinomatosis | ||||
| Brief Summary | RATIONALE: Hyperthermia therapy kills tumor cells by heating them to several degrees above body temperature. Peritoneal infusion of heated and nonheated chemotherapy drugs following surgery may kill more tumor cells. PURPOSE: This phase II trial is studying how well continuous hyperthermic peritoneal perfusion of cisplatin plus intraperitoneal infusions of paclitaxel and fluorouracil work in treating patients who have undergone surgery for peritoneal cancer. |
||||
| Detailed Description | OBJECTIVES:
OUTLINE: Patients are stratified according to histology (primary peritoneal mesothelioma vs low-grade mucinous adenocarcinoma [including low-grade mucinous neoplasms of borderline malignant potential] [closed to accrual as of 11/14/03] vs adenocarcinoma of gastrointestinal tract origin [other than low-grade mucinous, excluding pancreatic cancer]). Patients undergo cytoreductive surgery plus continuous hyperthermic peritoneal perfusion with cisplatin over 90 minutes on day 1 followed by intraperitoneal dwell chemotherapy with paclitaxel and fluorouracil over 60 minutes during the early postoperative period (days 7-12). Quality of life is assessed at study initiation, at 6 weeks, every 3 months for 1 year, and then every 6 months thereafter. Patients are followed at 4-6 weeks, every 3 months for 1 year, and then every 6 months for up to 4 years. PROJECTED ACCRUAL: A total of 179 patients (72 with peritoneal mesothelioma, 48 with low-grade mucinous adenocarcinoma [closed to accrual as of 11/14/03], and 59 with adenocarcinoma of gastrointestinal tract origin) will be accrued for this study within approximately 5-6 years. |
||||
| Study Phase | Phase II | ||||
| Study Type ICMJE | Interventional | ||||
| Study Design ICMJE | Treatment, Open Label | ||||
| Condition ICMJE |
|
||||
| Intervention ICMJE |
|
||||
| Study Arms / Comparison Groups | |||||
| Publications * |
|
||||
|
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
|||||
| Recruitment Information | |||||
| Recruitment Status ICMJE | Active, not recruiting | ||||
| Estimated Enrollment ICMJE | 179 | ||||
| Completion Date | |||||
| Primary Completion Date | |||||
| Eligibility Criteria ICMJE | DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS: Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Pulmonary:
Other:
PRIOR CONCURRENT THERAPY: Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
|
||||
| Gender | Both | ||||
| Ages | |||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT ID ICMJE | NCT00020059 | ||||
| Responsible Party | |||||
| Study ID Numbers ICMJE | CDR0000067690, NCI-00-C-0069 | ||||
| Study Sponsor ICMJE | National Cancer Institute (NCI) | ||||
| Collaborators ICMJE | |||||
| Investigators ICMJE |
|
||||
| Information Provided By | National Cancer Institute (NCI) | ||||
| Verification Date | April 2008 | ||||
|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
|||||