NCT00004910

Brief Summary

RATIONALE: The use of endoscopy to place metal stents in the duodenum is less invasive than surgery for treating cancer-related duodenal obstruction and may have fewer side effects and improve recovery. PURPOSE: Phase I/II trial to study the effectiveness of endoscopic placement of metal stents in treating patients who have cancer-related obstruction of the duodenum.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Timeline
Completed

Started Jan 2000

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2000

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 7, 2000

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2003

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2003

Completed
3 months until next milestone

First Posted

Study publicly available on registry

May 9, 2003

Completed
Last Updated

June 6, 2012

Status Verified

May 1, 2012

Enrollment Period

3.1 years

First QC Date

March 7, 2000

Last Update Submit

May 31, 2012

Conditions

Colorectal CancerConstipation, Impaction, and Bowel ObstructionExtrahepatic Bile Duct CancerGastric CancerGastrointestinal Carcinoid TumorGastrointestinal Stromal TumorPancreatic CancerQuality of LifeSmall Intestine Cancer

Keywords

stage I colon cancerstage II colon cancerstage III colon cancerstage IV colon cancerstage I gastric cancerstage II gastric cancerstage III gastric cancerstage IV gastric cancerrecurrent gastric cancerstage I pancreatic cancerstage II pancreatic cancerstage III pancreatic cancerrecurrent pancreatic cancerrecurrent colon cancerlocalized gastrointestinal carcinoid tumorregional gastrointestinal carcinoid tumormetastatic gastrointestinal carcinoid tumorrecurrent gastrointestinal carcinoid tumorsmall intestine adenocarcinomasmall intestine lymphomasmall intestine leiomyosarcomalocalized extrahepatic bile duct cancerunresectable extrahepatic bile duct cancerrecurrent extrahepatic bile duct cancerrecurrent small intestine cancerconstipation, impaction, and bowel obstructionquality of lifegastrointestinal stromal tumorstage IV pancreatic cancer

Interventions

bowel obstruction managementPROCEDURE
quality-of-life assessmentPROCEDURE

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: * Endoscopically confirmed localized tumor as the cause of duodenal obstruction * All primary tumor types are eligible * No prior duodenal Wallstents * Must have symptoms of gastrointestinal obstruction, including: * Inability to move bowels, absence of flatus, nausea/vomiting, abdominal pain, or diarrhea PATIENT CHARACTERISTICS: Age: * 18 and over Performance status: * ECOG 0-3 Life expectancy: * Not specified Hematopoietic: * Platelet count greater than 50,000/mm\^3 Hepatic: * INR no greater than 1.5 times upper limit of normal Renal: * Not specified Cardiovascular: * No cardiac condition Other: * Not pregnant or nursing * Fertile patients must use effective contraception * No significant active infection (e.g., pneumonia, peritonitis, or wound abscess) that would preclude endoscopy * No other serious concurrent illness * No uncontrolled metabolic disease (e.g., diabetes mellitus or hypothyroidism) * No dementia, psychiatric disorder, or altered mental status that would preclude compliance * History of other neoplastic disease allowed * Veterans Administration patients are not eligible PRIOR CONCURRENT THERAPY: Biologic therapy: * Not specified Chemotherapy: * Prior or concurrent chemotherapy allowed Endocrine therapy: * Not specified Radiotherapy: * Prior or concurrent radiotherapy allowed Surgery: * At least 3 weeks since prior surgery and recovered

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

Robert H. Lurie Comprehensive Cancer Center, Northwestern University

Chicago, Illinois, 60611-3013, United States

Location

MeSH Terms

Conditions

Colorectal NeoplasmsConstipationIntestinal ObstructionBile Duct NeoplasmsStomach NeoplasmsGastrointestinal Stromal TumorsPancreatic NeoplasmsColonic Neoplasms

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal DiseasesSigns and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and SymptomsBiliary Tract NeoplasmsBile Duct DiseasesBiliary Tract DiseasesStomach DiseasesNeoplasms, Connective TissueNeoplasms, Connective and Soft TissueNeoplasms by Histologic TypeEndocrine Gland NeoplasmsPancreatic DiseasesEndocrine System Diseases

Study Officials

  • Willis G. Parsons, MD, PC

    Robert H. Lurie Cancer Center

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 1
Purpose
SUPPORTIVE CARE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 7, 2000

First Posted

May 9, 2003

Study Start

January 1, 2000

Primary Completion

February 1, 2003

Study Completion

February 1, 2003

Last Updated

June 6, 2012

Record last verified: 2012-05

Locations

US(1)