superficial pharyngeal cancer
Conditions
Interventions
An appropriate amount of the peptide-based absorbable topical hemostatic agent (PURESTAT) will be evenly applied to the ulcer base following ESD, ELPS, or TORS for pharyngeal tumors, with a maximum vo
Sponsors
Hiroshima University
3-D Matrix, Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1 Diagnosed with primary pharyngeal squamous cell carcinoma including high-grade dysplasia HGD or basaloid carcinoma by endoscopy or histopathology 2 Tumor is endoscopically confined to the epithelial EP or subepithelial SEP layer 3 No lymph node or distant metastasis on contrast-enhanced CT slice <=10 mm from neck to abdomen or PET-CT cN0M0 UICC TNM 8th ed Non-contrast CT allowed if renal dysfunction contrast allergy or asthma 4 ESD ELPS or TORS is planned for a lesion meeting at least one of the following Expected resected specimen >=35 mm Lesion developed after cervical radiotherapy Residual or recurrent lesion post-RT or CRT for pharyngeal cancer 5 Single lesion in pharynx or esophagus or all other lesions <10 mm 6 Age 18 to 85 at informed consent 7 ECOG performance status 0 to 1 8 No prior surgery for laryngeal pharyngeal or esophageal cancer 9 CTCAE JCOG dysphagia grade <=2 10 Lab values within 90 days before registration WBC >=2000 and <=12000 per mm3 Hemoglobin >=8.0 g per dL Platelets >=100000 per mm3 Total bilirubin <=2.0 mg per dL AST <=150 IU per L ALT <=150 IU per L Creatinine <=2.0 mg per dL 11 Written informed consent obtained Secondary screening 12 Target lesion confined to pharynx completely resected by ESD ELPS or TORS and meets at least one of the following Resected specimen >=35 mm Lesion developed after cervical radiotherapy Residual or recurrent lesion post-RT or CRT for pharyngeal cancer
Exclusion criteria
Exclusion criteria: 1 Active multiple cancers including synchronous or metachronous cancers with disease-free interval less than 1 year Exceptions include superficial pharyngeal cancer stage 0 esophageal cancer or completely resected cancers in the following stages Gastric colon or rectal adenocarcinoma stage 0 to I Breast cancer DCIS LCIS stage 0 IDC ILC Paget stage 0 to IIA Endometrial adenocarcinoma stage I Prostate cancer stage I to II Cervical SCC stage 0 Thyroid cancer papillary or follicular stage I to III Renal cell carcinoma clear cell or chromophobe type stage I 2 Lesion involving larynx 3 Systemic infection requiring treatment 4 Fever 38.0C or higher at axilla at provisional registration 5 Female patients who are pregnant possibly pregnant within 28 days postpartum or breastfeeding 6 Psychiatric illness or symptoms that make study participation difficult 7 Receiving continuous systemic corticosteroids or immunosuppressants oral or IV 8 Receiving inhaled corticosteroid therapy 9 Uncontrolled hypertension 10 Unstable angina within 3 weeks or history of myocardial infarction within 6 months 11 Respiratory disease requiring continuous oxygen therapy 12 History of allergy to peptide-based or protein-based agents
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Severity of dysphagia assessed by the Functional Outcome Swallowing Scale (FOSS) at 24 weeks following Endoscopic Submucosal Dissection (ESD), Endoscopic Laryngopharyngeal Surgery (ELPS), or Transoral Robotic Surgery (TORS) | — |
Secondary
| Measure | Time frame |
|---|---|
| everity of dysphagia (FOSS) at 12 weeks after ESD, ELPS, or TORS Severity of dysphagia at each time point (assessed using the Functional Outcome Swallowing Scale [FOSS] and Common Terminology Criteria for Adverse Events [CTCAE, JCOG version]) Degree of pharyngeal pain (assessed using the Numerical Rating Scale [NRS]) Presence or absence of gastrostomy Duration of fasting Introduction of swallowing rehabilitation (yes/no) Incidence of postoperative pneumonia Proportion of cases in which a standard endoscope could not pass through the esophagus Residual ulcer rate and incidence of scar contracture at 4, 12, and 24 weeks after ESD, ELPS, or TORS Incidence of adverse events Incidence of serious adverse events | — |
Countries
Japan
Contacts
Public ContactYuji Urabe
Hiroshima University Hospital Department of Gastroenterology
Outcome results
None listed