This trial is active, not recruiting.

Condition unspecified adult solid tumor, protocol specific
Treatment radiosurgery
Phase phase 1/phase 2
Sponsor Comprehensive Cancer Center of Wake Forest University
Collaborator National Cancer Institute (NCI)
Start date June 2002
End date September 2007
Trial size 48 participants
Trial identifier NCT00311597, CCCWFU-99502, CCCWFU-BG02-187, CDR0000466064


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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation non-randomized
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Single fractionated radiation adjusted for volume of tumor tissue encompassed by desired isodose line
single fractionated radiation therapy

Primary Outcomes

Maximum tolerated dose for up to 90 days after completion of study treatment
time frame: 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
time frame: day 1 through 90

Secondary Outcomes

Median time to progression of treated tumor for up to 2 years
time frame: 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
time frame: day 1 through 90
Cause of death as assessed by medical records and autopsy at time of death
time frame: variable, survival of the patient

Eligibility Criteria

Male or female participants at least 18 years old.

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)

Additional Information

Official title A Phase I/II Dose-Escalation/Efficacy Study of Palliative Extracranial Radiosurgery Using the Elektra Stereotactic Body Frame System
Description OBJECTIVES: Primary - Establish the maximum tolerated dose (MTD) of extracranial stereotactic radiosurgery in patients with isolated tumors. (Phase I) - Determine the minimum dose required for local control. (Phase II) Secondary - Determine the radiographic response rate. - Determine the median time to progression of the treated tumor. - Evaluate the toxicity of treatment. - Evaluate the cause of death. OUTLINE: This is a phase I dose-escalation study followed by a phase II open-label study. Patients are stratified according to tumor size. - Phase I: Patients undergo stereotactic radiosurgery to one lesion. Cohorts of 3-6 patients undergo escalating doses of stereotactic radiosurgery until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose at which 33% of patients experience dose-limiting toxicity within 3 months of treatment. - Phase II: Patients undergo stereotactic radiosurgery to one lesion at the MTD or at the dose at which local control at 3 months is ≥ 80%, as determined in phase I. After completion of study treatment, patients are followed at 1 month, 3 months, and then every 3 months thereafter. PROJECTED ACCRUAL: At least 48 patients will be accrued for this study.
Trial information was received from ClinicalTrials.gov and was last updated in September 2014.
Information provided to ClinicalTrials.gov by Comprehensive Cancer Center of Wake Forest University.