Extracranial Stereotactic Radiosurgery in Treating Patients With Solid Tumors

NCT00311597 | Completed Phase 1

• 3 other identifiers: CDR0000466064CCCWFU-99502CCCWFU-BG02-187
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief Summary

RATIONALE: Extracranial stereotactic radiosurgery may be able to send x-rays directly to the tumor and cause less damage to normal tissue. PURPOSE: This phase I/II trial is studying the side effects and best dose of extracranial stereotactic radiosurgery and to see how well it works in treating patients with solid tumors.

Conditions

Unspecified Adult Solid Tumor, Protocol Specific

Keywords

unspecified adult solid tumor, protocol specific

Outcome Measures

Primary Outcomes (2)

• Maximum tolerated dose for up to 90 days after completion of study treatment

  day 1 through 90

• Minimum dose required for local control as assessed by RECIST one-dimensional criterion and volumetric analysis for 90 days after completion of study treatment

  day 1 through 90

Secondary Outcomes (3)

• Median time to progression of treated tumor for up to 2 years

  day 1 to 2 years

• Toxicity as assessed by NCI Common Toxicity Criteria (CTC) version 2.0 for up to 90 days after completion of study treatment

  day 1 through 90

• Cause of death as assessed by medical records and autopsy at time of death

  variable, survival of the patient

Study Arms (1)

Single fractionated radiation adjusted for tumor size

EXPERIMENTAL

Single fractionated radiation adjusted for volume of tumor tissue encompassed by desired isodose line

Procedure: Radiosurgery

Interventions

Radiosurgery PROCEDURE

single fractionated radiation therapy

Single fractionated radiation adjusted for tumor size

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

DISEASE CHARACTERISTICS: * Presence of well-circumscribed tumor on contrast-enhanced CT scan or MRI * Maximum diameter of 6 cm PATIENT CHARACTERISTICS: * Life expectancy ≥ 3 months * Not pregnant * Fertile patients must use effective contraception * Negative pregnancy test * Must be able to tolerate CT scan or MRI contrast PRIOR CONCURRENT THERAPY: * At least 3 weeks since prior chemotherapy or immunotherapy * No prior treatment on this study * No chemotherapy or immunotherapy during and for 4 weeks after completion of study treatment * No concurrent external-beam radiotherapy overlapping with the radiosurgically-treated volume (including low-dose regions)

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Wake Forest University Comprehensive Cancer Center

Winston-Salem, North Carolina, 27157-1096, United States

Location

Related Publications (1)

• Stieber VW, Hinson W, Kearns W, et al.: A phase I/II dose-escalation/efficacy study of palliative stereotactic body radiosurgery, including bioanatomic imaging to assess response. [Abstract] Int J Radiat Oncol Biol Phys 60 (1 Suppl 1): A-2381, S563-4, 2004.

  RESULT

MeSH Terms

Interventions

Radiosurgery

Intervention Hierarchy (Ancestors)

Radiotherapy; Therapeutics; Stereotaxic Techniques; Neurosurgical Procedures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• James Urbanic, MD

  Wake Forest University Health Sciences

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 5, 2006
• First Posted: April 6, 2006
• Study Start: June 1, 2002
• Primary Completion: September 1, 2007
• Study Completion: March 1, 2009
• Last Updated: March 14, 2017

Record last verified: 2017-03

Locations

US (1)