Clinical trial · Interventional
The Management of Metastatic Neck Nodes in N2/3 Hypopharyngeal Squamous Cell Carcinoma
The Management of Metastatic Neck Nodes in N2/3 Hypopharyngeal Squamous Cell Carcinoma: A Multi-center Randomized Controlled Prospective Study
NCT05494190CI-TRIAL-00099839recruitingN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This is a multi-center, multidisciplinary, open-label, randomized controlled prospective clinical study.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Hypopharyngeal Carcinoma | Hypopharyngeal Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Capecitabine | Drug | Capecitabine | ALIAS |
| Cisplatin | Drug | Cisplatin | ALIAS |
| Concomitant chemoradiotherapy | Radiation | — | UNRESOLVED |
| Docetaxel | Drug | Docetaxel | ALIAS |
| Surgery | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Induction chemotherapy group
- description
- Patients initially receive induction chemotherapy consisting of docetaxel, cisplatin and capecitabine (TPC), q3w, 2-3 cycles in total. Patients with regional response of complete reaction (CR)/partial reaction (PR)≥50% after induction chemotherapy then receive concomitant chemoradiotherapy for both the primary and regional sites. Patients with regional response of PR\<50%/stable disease (SD)/progressive disease (PD) after induction chemotherapy then receive surgery for both the primary and regional sites and postoperative concomitant chemoradiotherapy.
- interventionNames
- Drug: Docetaxel
- Drug: Cisplatin
- Drug: Capecitabine
- Radiation: Concomitant chemoradiotherapy
- Procedure: Surgery
- type
- ACTIVE_COMPARATOR
- label
- Surgery group
- description
- Patients initially receive surgery for both the primary and regional sites and postoperative concomitant chemoradiotherapy.
- interventionNames
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: 1. Able to understand and willing to sign a written informed consent document. 2. Age ≥ 18 and ≤ 75 years. 3. Male or female. 4. Karnofsky physical status (KPS): ≥ 80 5. Hepatic function, renal function and normal blood test. Hepatic function: Alanine aminotransferase (ALT) ≤ 2.5 upper limit of normal, Aspartate aminotransferase (AST) ≤ 2.5 upper limit of normal. Serum total bilirubin ≤ 1.5 upper limit of normal. Kidney function: Serum creatinine \< upper limit of normal value and creatinine clearance rate \> 60 ml/(min\*1.73m2) (Cockcroft-Gault formula). Blood test: neutrophil (Neu) ≥ 1.5×109/L, platelet (PLT) ≥ 100×109/L, hemoglobin (HGB) ≥ 90 g/L. 6. Pathologically diagnosed with squamous cell carcinoma of the hypopharynx. 7. After clinical and radiographic evaluations, clinically classified as T1/2 N2/3 M0 stage according to American Joint Committee on Cancer (AJCC, eighth edition). 8. Resectable regional metastatic lesion (incompletely tumor- wrapped carotid vascular). 9. Assessable tumor lesions according to Response Evaluation Criteria in Solid Tumors (RECIST, Version 1.1). 10. Radical treatment intent. 11. Male patients with fertility and female patients with fertility and pregnancy risk must agree to use contraceptive methods throughout the study period, and continued until at least 6 months after the last dose of cisplatin. Female patients who do not have fertility (ie meet at least one of the following criteria): Have undergone hysterectomy and/or bilateral oophorectomy with archival records, medically confirmed ovarian function decline; In postmenopausal state. It is defined as: At least 12 months of continuous menstruation without other pathological or physiological reasons, and the status confirmed by serum follicle stimulating hormone (FSH) levels is consistent with postmenopausal status. 12. Good compliance. Exclusion Criteria: 1. Distant metastatic disease 2. Have a history of other cancers or coinstantaneous second primary tumor 3. Previous treatment for the primary tumor, including radiotherapy, surgery except biopsy operation, chemotherapy, immunotherapy and biological targeted therapy. 4. Patients who have participated in other clinical trials within 1 month before the test. 5. Patients estimated to have poor tolerance to induction chemotherapy. 6. The investigator believes that it is inappropriate for individuals to participate in the trial: having, for example, severe acute or chronic medical conditions (including immune colitis, inflammatory bowel disease, non-infectious pneumonia, pulmonary fibrosis) or mental illness (including recent time \[within the past year\] or active suicidal ideation or behavior). 7. Palliative treatment intent. 8. Pregnant or lactating women.
References
Publications (0)
Data not yet available
No reference posted for this study.