Endoscopic Placement of Metal Stents in Treating Patients With Cancer- Related Duodenal Obstruction

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Primary Purpose

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

bowel obstruction management

quality-of-life assessment

About this trial

This is an interventional supportive care trial for Colorectal Cancer focused on measuring stage I colon cancer, stage II colon cancer, stage III colon cancer, stage IV colon cancer, stage I gastric cancer, stage II gastric cancer, stage III gastric cancer, stage IV gastric cancer, recurrent gastric cancer, stage I pancreatic cancer, stage II pancreatic cancer, stage III pancreatic cancer, recurrent pancreatic cancer, recurrent colon cancer, localized gastrointestinal carcinoid tumor, regional gastrointestinal carcinoid tumor, metastatic gastrointestinal carcinoid tumor, recurrent gastrointestinal carcinoid tumor, small intestine adenocarcinoma, small intestine lymphoma, small intestine leiomyosarcoma, localized extrahepatic bile duct cancer, unresectable extrahepatic bile duct cancer, recurrent extrahepatic bile duct cancer, recurrent small intestine cancer, constipation, impaction, and bowel obstruction, quality of life, gastrointestinal stromal tumor, stage IV pancreatic cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Robert H. Lurie Comprehensive Cancer Center, Northwestern University

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

NCT ID

NCT00004910

First Posted

March 7, 2000

Last Updated

May 31, 2012

Sponsor

Northwestern University

Collaborators

National Cancer Institute (NCI)

1. Study Identification

Unique Protocol Identification Number

NCT00004910

Brief Title

Endoscopic Placement of Metal Stents in Treating Patients With Cancer- Related Duodenal Obstruction

Official Title

A Pilot Phase I/II Trial of Enteral Wallstents for Duodenal Obstruction in the Setting of Malignancy

Study Type

Interventional

2. Study Status

Record Verification Date

May 2012

Overall Recruitment Status

Completed

Study Start Date

January 2000 (undefined)

Primary Completion Date

February 2003 (Actual)

Study Completion Date

February 2003 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Northwestern University

Collaborators

National Cancer Institute (NCI)

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

Detailed Description

OBJECTIVES: Determine the objective response and clinical outcome in patients with duodenal obstruction secondary to malignancy treated with enteral Wallstents. Evaluate the efficacy and safety of this treatment in these patients. Evaluate the quality of life of these patients after enteral Wallstent placement. OUTLINE: Patients undergo enteral Wallstent placement through an endoscope under fluoroscopic guidance into the duodenum. Quality of life is assessed at 48 hours and 6 months after procedure. Patients are followed at 48 hours, 30 days, 6 months, and then yearly thereafter until death. PROJECTED ACCRUAL: A total of 20 patients will be accrued for this study.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Colorectal Cancer, Constipation, Impaction, and Bowel Obstruction, Extrahepatic Bile Duct Cancer, Gastric Cancer, Gastrointestinal Carcinoid Tumor, Gastrointestinal Stromal Tumor, Pancreatic Cancer, Quality of Life, Small Intestine Cancer

Keywords

stage I colon cancer, stage II colon cancer, stage III colon cancer, stage IV colon cancer, stage I gastric cancer, stage II gastric cancer, stage III gastric cancer, stage IV gastric cancer, recurrent gastric cancer, stage I pancreatic cancer, stage II pancreatic cancer, stage III pancreatic cancer, recurrent pancreatic cancer, recurrent colon cancer, localized gastrointestinal carcinoid tumor, regional gastrointestinal carcinoid tumor, metastatic gastrointestinal carcinoid tumor, recurrent gastrointestinal carcinoid tumor, small intestine adenocarcinoma, small intestine lymphoma, small intestine leiomyosarcoma, localized extrahepatic bile duct cancer, unresectable extrahepatic bile duct cancer, recurrent extrahepatic bile duct cancer, recurrent small intestine cancer, constipation, impaction, and bowel obstruction, quality of life, gastrointestinal stromal tumor, stage IV pancreatic cancer

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Phase 1, Phase 2

8. Arms, Groups, and Interventions

Intervention Type

Procedure

Intervention Name(s)

bowel obstruction management

Intervention Type

Procedure

Intervention Name(s)

quality-of-life assessment

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

No

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Willis G. Parsons, MD, PC

Organizational Affiliation

Robert H. Lurie Cancer Center

Official's Role

Study Chair

Facility Information:

Facility Name

Robert H. Lurie Comprehensive Cancer Center, Northwestern University

City

Chicago

State/Province

Illinois

ZIP/Postal Code

60611-3013

Country

United States

Colorectal Cancer, Constipation, Impaction, and Bowel Obstruction, Extrahepatic Bile Duct Cancer

About this trial

Eligibility Criteria

Sites / Locations

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

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