NCT00026936

Brief Summary

The utility of PEREGRINE Monte Carlo calculations for radiation treatment planning in a clinical setting will be assessed by comparing results with other fully three-dimensional programs. ROB will investigate PEREGRINE for clinical use at NCI in collaboration with Lawrence Livermore National Laboratory (LLNL).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
140

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started May 1999

Longer than P75 for phase_2

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

May 1, 1999

Completed
2.5 years until next milestone

First Submitted

Initial submission to the registry

November 14, 2001

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 15, 2001

Completed
3.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2005

Completed
Last Updated

March 4, 2008

Status Verified

January 1, 2005

First QC Date

November 14, 2001

Last Update Submit

March 3, 2008

Conditions

Neoplasm

Keywords

External Beam RadiotherapyTCPDVHNTCP3-D Programming

Interventions

RadiotherapyPROCEDURE

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with documented malignancy requiring standard radiotherapy OR patients with a benign condition for whom radiotherapy is indicated.

You may not qualify if:

  • Documented connective tissue disease or Ataxia Telangiectasia.
  • Cognitively impaired patients who cannot give informed consent.
  • Other medical conditions deemed by the PI to make the patient ineligible.
  • Patients requiring emergent radiotherapy.
  • Patients who are not able to undergo a CT scan.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Cancer Institute (NCI)

Bethesda, Maryland, 20892, United States

Location

Related Publications (3)

  • Perez CA, Purdy JA, Harms W, Gerber R, Graham MV, Matthews JW, Bosch W, Drzymala R, Emami B, Fox S, et al. Three-dimensional treatment planning and conformal radiation therapy: preliminary evaluation. Radiother Oncol. 1995 Jul;36(1):32-43. doi: 10.1016/0167-8140(95)01566-y.

    PMID: 8525023BACKGROUND

  • Lawrence TS, Ten Haken RK, Kessler ML, Robertson JM, Lyman JT, Lavigne ML, Brown MB, DuRoss DJ, Andrews JC, Ensminger WD, et al. The use of 3-D dose volume analysis to predict radiation hepatitis. Int J Radiat Oncol Biol Phys. 1992;23(4):781-8. doi: 10.1016/0360-3016(92)90651-w.

    PMID: 1618671BACKGROUND

  • Yorke ED, Kutcher GJ, Jackson A, Ling CC. Probability of radiation-induced complications in normal tissues with parallel architecture under conditions of uniform whole or partial organ irradiation. Radiother Oncol. 1993 Mar;26(3):226-37. doi: 10.1016/0167-8140(93)90264-9.

    PMID: 8316652BACKGROUND

MeSH Terms

Conditions

Neoplasms

Interventions

Radiotherapy

Intervention Hierarchy (Ancestors)

Therapeutics

Study Design

Study Type
interventional
Phase
phase 2
Purpose
TREATMENT
Sponsor Type
NIH

Study Record Dates

First Submitted

November 14, 2001

First Posted

November 15, 2001

Study Start

May 1, 1999

Study Completion

January 1, 2005

Last Updated

March 4, 2008

Record last verified: 2005-01

Locations

US(1)