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CompletedNCT00233415Updated Jun 2, 2010

Cyberknife Radiosurgery for Locally Advanced Pancreatic Cancer

A Phase 2 interventional study of Stereotactic Radiosurgery (Cyberknife) in Pancreatic Cancer, sponsored by Stanford University. Completed at 1 site in United States. Open to participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2010-06-02.

Sponsored by Stanford University · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
100
Allocation
Non-randomized
Ages
18 Years to 90 Years
Sex
All
01

Study summary

The purpose of the trial is to test the efficacy of combining conventional chemoradiotherapy with radiosurgery for locally advanced pancreas cancer.

Read the detailed description

The purpose of the trial is to test the efficacy of treating locally advanced pancreatic cancer with 5FU and concurrent conventional radiotherapy followed by precisely administered single fraction of high-energy radiation using a radiosurgical technique.

02

Conditions studied

  • Pancreatic Cancer
03

In context

Pancreatic Neoplasms

3,310 studies on the registry are indexed under Pancreatic Neoplasms; 910 are open to participants now.

This study's enrollment of 100 is above the median of 46 across 2,480 interventional studies indexed under Pancreatic Neoplasms.

Browse Pancreatic Neoplasms studies →

Lead sponsor

Stanford University is the lead sponsor of 2,161 studies on the registry; 428 are open to participants now.

Of its 268 completed or terminated interventional studies of FDA-regulated products, 207 (77%) have results posted.

Browse Stanford University studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 90 Years
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

Inclusion Criteria:- Pancreatic tumors not to exceed 7.5 cm.

  • Histologically confirmed malignancies of the pancreas, (ampulla of Vater or periampullary duodenum, tumors may be included when the head of pancreas is secondarily involved and unresectable criteria are met).
  • Unresectable by CT criteria or unresectable at exploratory laparotomy or laparoscopy. CT criteria for unresectability include encasement of the superior mesenteric vein (SMV), portal vein (PV) or invasion of the celiac artery or superior mesenteric artery (SMA).
  • Patients with metastatic disease may be treated if they are symptomatic from the primary tumor.
  • Eastern Clinical Oncology Group performance status 0, 1 or 2. Exclusion Criteria:Chemotherapy within 1 month of registration.
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
100 participants (actual)

Interventions

  • DeviceStereotactic Radiosurgery (Cyberknife)
06

What researchers measure

Primary outcomes

  1. Efficacy of Conventional Chemoradiotherapy Followed by Stereotactic Radiosurgery

07

Study locations

1 site
  • Stanford University School of Medicine
    Stanford, California 94305, United States
08

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Jul 2003, a primary completion of Mar 2006 and a completion of May 2007. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 3, 2005
First posted
Oct 5, 2005
Start
Jul 2003
Primary completionActual
Mar 2006
CompletionActual
May 2007
Last update
Jun 2, 2010
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jun 2, 2010, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00233415
Lead sponsor
Stanford University
First posted
Oct 5, 2005
Start date
Jul 2003
Primary completion
Mar 2006
Completion
May 2007
Last update
Jun 2, 2010

Study contacts

Albert Koong
principal investigator · Stanford University
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2010. You cannot join it, but the record below documents what was studied.

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Discussion

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