A Pilot Study to Investigate the Clinical Utility of the Peregrine Monte Carlo Dose Calculation System for Radiation Therapy Treatment Planning

Neoplasm Clinical Trial

Official title:

A Pilot Study to Investigate the Clinical Utility of the Peregrine Monte Carlo Dose Calculation System for Radiation Therapy Treatment Planning

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00026936
• Other study ID #: 990116
• Secondary ID: 99-C-0116
• Status: Completed
• Phase: Phase 2
• First received: November 14, 2001
• Last updated: March 3, 2008
• Start date: May 1999
• Est. completion date: January 2005

Study information

• Verified date: January 2005
• Source: National Institutes of Health Clinical Center (CC)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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).

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 140
• Est. completion date: January 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

INCLUSION CRITERIA:

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

EXCLUSION CRITERIA:

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.

Study Design

Endpoint Classification: Safety/Efficacy Study, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Neoplasm

Intervention

Procedure:
• Radiotherapy

Locations

Country	Name	City	State
United States	National Cancer Institute (NCI)	Bethesda	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

References & Publications (3)

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. — View Citation

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. — View Citation

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. — View Citation