CyberKnife Accelerated Hemilarynx Stereotactic Radiotherapy Study for Early-stage Glottic Larynx … (NCT01984502) | Clinical Trial Compass
CompletedPhase 1
CyberKnife Accelerated Hemilarynx Stereotactic Radiotherapy Study for Early-stage Glottic Larynx Cancer
United States30 participantsStarted 2013-11-18
Plain-language summary
The feasibility of reducing fractions in early-stage laryngeal cancer has not previously been prospectively studied, and we will therefore conduct a careful phase I bio-equivalent dose fraction reduction study.
Who can participate
Age range18 Years – 99 Years
SexALL
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Inclusion criteria
✓.1.1 Stage Tis, T1, or T2 laryngeal squamous cancer as defined by American Joint Commission on Cancer (AJCC) 2007 staging system
✓.1.2 Biopsy proven squamous cell carcinoma histology or squamous cell variants (sarcomatoid, verrucous, basaloid, and papillary subtypes) involving the true vocal cord
✓.1.3 Direct laryngoscopy showing no evidence of greater than Stage II true glottic larynx cancer
✓.1.4 PET/CT, X-ray, CT-scan of the chest showing no evidence of metastatic disease
✓.1.5 PET/CT or CT-scan of the neck showing no evidence of nodal involvement
✓.1.6 Age ≥ 18 years.
✓.1.7 Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and for 90 days following completion of therapy. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.
✓.1.7.1 A female of child-bearing potential is any woman (regardless of sexual orientation, having undergone a tubal ligation, or remaining celibate by choice) who meets the following criteria:
Exclusion criteria
✕.2.1 Evidence of fixed vocal cord (Stage cT3)
✕.2.2 Evidence of thyroid or soft tissue invasion (Stage cT4)
What they're measuring
1
Fraction
Timeframe: 90 days
Trial details
NCT IDNCT01984502
SponsorUniversity of Texas Southwestern Medical Center