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


Phase 1/Phase 2
18 Years
N/A
Not Enrolling
Both
Colorectal Cancer, Constipation, Impaction, and Bowel Obstruction, Gastric Cancer, Gastrointestinal Carcinoid Tumor, Gastrointestinal Stromal Tumor, Quality of Life, Small Intestine Cancer

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Trial Information

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


OBJECTIVES:

- Determine the objective response and clinical outcome in patients with colonic
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: All patient undergo a colonoscopy, followed by placement of an enteral Wallstent
through an endoscope under fluoroscopic guidance into the large intestine.

Quality of life is assessed at 48 hours and 6 months after the 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.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Endoscopically confirmed localized tumor as the cause of colonic obstruction

- All primary tumor types are eligible

- No prior colonic 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, wound abscess) that
would preclude endoscopy

- No other serious concurrent illness

- No uncontrolled metabolic disease (e.g., diabetes 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

Type of Study:

Interventional

Study Design:

Primary Purpose: Supportive Care

Principal Investigator

Willis G. Parsons, MD, PC

Investigator Role:

Study Chair

Investigator Affiliation:

Robert H. Lurie Cancer Center

Authority:

United States: Federal Government

Study ID:

NU 98CC3

NCT ID:

NCT00004911

Start Date:

January 2000

Completion Date:

February 2003

Related Keywords:

  • Colorectal Cancer
  • Constipation, Impaction, and Bowel Obstruction
  • Gastric Cancer
  • Gastrointestinal Carcinoid Tumor
  • Gastrointestinal Stromal Tumor
  • Quality of Life
  • Small Intestine Cancer
  • 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 rectal cancer
  • stage II rectal cancer
  • stage III rectal cancer
  • stage IV rectal cancer
  • recurrent colon cancer
  • recurrent rectal 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
  • recurrent small intestine cancer
  • constipation, impaction, and bowel obstruction
  • quality of life
  • gastrointestinal stromal tumor
  • Carcinoid Tumor
  • Colorectal Neoplasms
  • Constipation
  • Fecal Impaction
  • Intestinal Obstruction
  • Stomach Neoplasms
  • Duodenal Neoplasms
  • Ileal Neoplasms
  • Jejunal Neoplasms
  • Malignant Carcinoid Syndrome
  • Gastrointestinal Neoplasms
  • Gastrointestinal Stromal Tumors
  • Intestinal Neoplasms

Name

Location

Robert H. Lurie Comprehensive Cancer Center, Northwestern UniversityChicago, Illinois  60611