Prospective multicenter study for functional evaluation of transoral laser microsurgery (TLM) for supraglottic carcinomas - SUPRATOL

Prospective multicenter study for functional evaluation of transoral laser microsurgery (TLM) for supraglottic carcinomas - SUPRATOL - SUPRATOL

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

DRKS

Registry ID

DRKS00004641

Enrollment

200

Registered

2015-02-24

Start date

2015-04-08

Completion date

Unknown

Last updated

2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

C32

Interventions

Group 1: Transoral laser microsurgery (TLM) for supraglottic laryngectomy

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: • Histologically proven squamous cell carcinoma of the supraglottic larynx • T2 and T3 tumor (UICC, 7th edition 2010) • Stage II-IVb (UICC, 7th edition 2010) • Age =18 years • No pregnancy, reliable contraception during time of treatment • Written informed consent • Examination of swallowing function by FEES possible

Exclusion criteria

Exclusion criteria: • Tumor location outside the supraglottic larynx • R0 resection of cervical lymph node metastases not possible • Simultaneous distant metastases • Simultaneous second primary tumor • Previous malignant tumor, except basalioma and spinalioma of the skin and carcinomata in situ. • Malignant tumor in patient’s history with follow-up time less than 5 years. Patients without relapse within 5 years after therapy of a malignant tumor need consultation with the Principal Investigator. • Previous local, regional or systemic tumor therapy. • No suitability for general anesthesia. • Not tumor-related swallowing disorder.

Design outcomes

Primary

Measure	Time frame
Time to aspiration-free swallowing after end of treatment, examined with FEES (fiberoptic endoscopic evaluation of swallowing), defined as time after end of treatment until grade <6 at penetration-aspiration-scale (PAS) according to Rosenbeck.	—

Secondary

Measure	Time frame
• Local control, defined as time from study registration until local recurrence • Larynx preservation • Disease-specific survival, defined as time from study registration to tumor-related death • Overall survival, defined as time from study registration to death of any cause • Dysphagia- and voice-related quality of life, recorded by MD Anderson Dysphagia Inventory (MDADI) and Voice-Handicap-Index (VHI) • Complications of treatment • Severe adverse events • Tracheostomy temporary/permanent • Necessity of PEG-feeding	—

Measure

Time frame

• Local control, defined as time from study registration until local recurrence • Larynx preservation • Disease-specific survival, defined as time from study registration to tumor-related death • Overall survival, defined as time from study registration to death of any cause • Dysphagia- and voice-related quality of life, recorded by MD Anderson Dysphagia Inventory (MDADI) and Voice-Handicap-Index (VHI) • Complications of treatment • Severe adverse events • Tracheostomy temporary/permanent • Necessity of PEG-feeding

—

Countries

Germany

Contacts

Public ContactPetra Ambrosch

Universität zu Kiel/UKSH Campus KielKlinik für HNO-Heilkunde, Kopf- und Halschirurgie

ambrosch@hno.uni-kiel.de0431/597-2240

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 5, 2026