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Phase III Study of Somatostatin Analog vs Placebo for Inhibition of Postoperative Pancreatic Drainage in Patients Who Have Undergone Excision of Pancreatic Islet Cell Tumors (Summary Last Modified 04/92)

Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Trial Contact Information

Basic Trial Information

Phase
Type
Status
Age
Sponsor
Protocol IDs

Phase III

Supportive care

Completed

any age

NCI

NCI-89-C-80
NCI-T89-0090N, T89-0090

Objectives

I.  Determine whether postoperative pancreatic drainage in patients who have 
undergone surgery to resect an islet cell tumor can be substantially reduced 
by the use of somatostatin analog.

Entry Criteria

Disease Characteristics:


Pancreatic islet cell tumor requiring incision into the
pancreas for surgical excision

Prior/Concurrent Therapy:


Not specified

Patient Characteristics:


No diabetes

No gallstones documented on preoperative ultrasound or at the
time of surgery

Expected Enrollment

Initially, 11 patients will be studied on each treatment arm; if a 
statistically significant difference between the 2 treatment arms is not seen 
after accrual of the first 11 patients per arm, accrual will continue until 33 
patients per arm are entered, for a total of 66 patients.

Outline

Randomized, double-blind study.
Arm I:  Pancreatic Exocrine Inhibition.  Somatostatin Analog, Octreotide, 
Sandostatin, SMS-201-995.
Arm II:  Control.  Placebo.

Trial Contact Information

Trial Lead Organizations

NCI - Center for Cancer Research-Medical Oncology

Jeffrey Norton, MD, Protocol chair(Contact information may not be current)
Ph: 415-750-2057

Note: The purpose of most clinical trials listed in this database is to test new cancer treatments, or new methods of diagnosing, screening, or preventing cancer. Because all potentially harmful side effects are not known before a trial is conducted, dose and schedule modifications may be required for participants if they develop side effects from the treatment or test. The therapy or test described in this clinical trial is intended for use by clinical oncologists in carefully structured settings, and may not prove to be more effective than standard treatment. A responsible investigator associated with this clinical trial should be consulted before using this protocol.