Compare and report Patient Reported Voice Quality

Phase 3

• Conditions: Health Condition 1: C320- Malignant neoplasm of glottisHealth Condition 2: C329- Malignant neoplasm of larynx, unspecified

• Registration Number: CTRI/2022/11/047797
• Lead Sponsor: the Insel Gruppe AG Universittsklinik fr Allgemeine Innere Medizin Bern Switzerland

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 9 January 2023

Recruitment & Eligibility

• Status: ot Yet Recruiting
• Sex: Not specified
• Target Recruitment: 0

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified