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Evaluation of safety and efficacy of transoral robotic surgery for laryngo-pharyngeal cancer

Phase II trial of transoral robotic surgery for laryngo-pharyngeal cancer - Phase II trial of transoral robotic surgery for laryngo-pharyngeal cancer

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000036646
Enrollment
30
Registered
2019-08-01
Start date
2019-08-01
Completion date
Unknown
Last updated
2026-06-29

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

Conditions

Laryngo-pharyngeal cancer

Interventions

Sponsors

Kitasato University, School of Medicine
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: (1) Oropharyngeal, Hypopharyngeal or supraglottic cancer confirmed by pathological diagnosis (2) Tis-T2 or superficial T3 diagnosed by endoscopy or imaging test (CT, MRI or PET/CT) (3) Tumor invasion within pharyngeal constrictor (4) N0-N2b in p16-negative oropharyngeal, hypopharyngeal or supraglottic cancer (5) N0-1 in p16-positive oropharyngeal cancer (6) ECOG-PS 0-1 (7) Blood test results meeting the following requirements 1) Leukocyte count < 2,000/mm3 2) Platelate count < 100,000/mm3 3) AST= or <100 IU/L, ALT= or <100 IU/L 4) Total bilirubin= or <2.0 mg/dL (8) Age= or >20 (9) Providing written informed consent

Exclusion criteria

Exclusion criteria: (1) Poor exposure of surgical field due to trismus or difficulty of neck extension (2) Extranodal extention of lymph node metastasis (3) bilateral cervical lymph node metastases (4) Distant metastasis (5) Difficulty of discontinuation of anticoagulant or antiplatelet drug (6) Pregnancy (7) Unsuitable for inclusion at the discretion of the researchers

Design outcomes

Primary

MeasureTime frame
Positive rate of surgical margin

Secondary

MeasureTime frame
Postoperative swallowing function

Countries

Japan

Contacts

Public ContactShunsuke Miyamoto

Kitasato University School of Medicine

s-miya@kitasato-u.ac.jp042-778-8111

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026