Health Condition 1: C320- Malignant neoplasm of glottis Health Condition 2: C329- Malignant neoplasm of larynx, unspecified
Conditions
Interventions
Intervention1: Single Vocal Cord Irradiation (SVCI)
: As per Study Protocol this is a ARM-B. The Radiotherapy will be delivered over 16 fractions as 5 days per week.
Control Intervention1: Transoral C
Sponsors
the Insel Gruppe AG Universittsklinik fr Allgemeine Innere Medizin Bern Switzerland
Eligibility
Inclusion criteria
Inclusion criteria: 1. ECOG Performance status 0-1 2. =18 years of age 3. Histopathologically confirmed, previously untreated unilateral (cT1a or unilateral cTis) stage 0 or I glottic larynx cancer 4. History and physical examination within 28 days prior registrations
Exclusion criteria
Exclusion criteria: 1. Infection hampering the voice quality at the time of voice assessment 2. Involvement of the anterior commissure by the tumor 3. Previous oncologic surgery with curative intent (exception: excisional biopsies resulting in unacceptable close R0 or R1/R2 margins may be included) or radiotherapy to larynx 4. Synchronous or previous malignancies. Exceptions are adequately treated basal cell carcinoma or SCC of the skin, or in situ carcinoma of the cervix uteri, low-risk prostate cancer or breast with a cancer-free follow-up time of at least 3 years, or other previous malignancy with a progression-free interval of at least 5 years 5. Co-existing disease prejudicing survival (expected survival less than 6 months) 6. Active bacterial or fungal infection requiring intravenous antibiotics at the time of registration 7. History of any voice disorders (not related to the SCCGL) lasting longer than 3 weeks 8. Illness requiring hospitalization or precluding study therapy within 28 days before registration 9. Presence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Average of the VHI assessed at 6, 12, 18, and 24 monthsTimepoint: 6, 12, 18, and 24 months | — |
Secondary
| Measure | Time frame |
|---|---|
| VHI separately assessed at 6, 12, 18, and 24 months Perceptual impression of the voice via Roughness ? Breathiness ? Hoarseness (RBH) assessment at 6, 12, 18, and 24 months Quantitative characteristics of voice by means of Jitter and Shimmer (JS), Glottal-to-Noise Excitation Ratio (GNE) and Singing Power Ratio (SPR), which will be assessed at 6, 12, 18, and 24 months Loco-regional control of the disease at 2 and 5 years Treatment toxicity at 2 and 5 years based on CTCAE v.5.0Timepoint: 6, 12, 18, and 24 months | — |
Countries
India
Contacts
Public ContactDr Deepa Nair
TATA MEMORIAL HOSPITAL
Outcome results
None listed