Hypopharyngeal CarcinomaNCT05494190
The Management of Metastatic Neck Nodes in N2/3 Hypopharyngeal Squamous Cell Carcinoma
A study testing Docetaxel, Cisplatin and Capecitabine in people with Hypopharyngeal Carcinoma, run by Eye & ENT Hospital of Fudan University at 3 sites in China.
Trial summary
This is a multi-center, multidisciplinary, open-label, randomized controlled prospective clinical study. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Hypopharyngeal Carcinoma
- What is being tested?
- Docetaxel, Cisplatin and Capecitabine
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 111 participants
- Where
- 3 sitesChina
- Study dates
- 1 Nov 2022to Nov 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Able to understand and willing to sign a written informed consent document.
- Age ≥ 18 and ≤ 75 years.
- Male or female.
- Karnofsky physical status (KPS): ≥ 80
- 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.
- Pathologically diagnosed with squamous cell carcinoma of the hypopharynx.
Show all 12Show fewer
- After clinical and radiographic evaluations, clinically classified as T1/2 N2/3 M0 stage according to American Joint Committee on Cancer (AJCC, eighth edition).
- Resectable regional metastatic lesion (incompletely tumor- wrapped carotid vascular).
- Assessable tumor lesions according to Response Evaluation Criteria in Solid Tumors (RECIST, Version 1.1).
- Radical treatment intent.
- 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.
- Good compliance.
Who cannot join
- Distant metastatic disease
- Have a history of other cancers or coinstantaneous second primary tumor
- Previous treatment for the primary tumor, including radiotherapy, surgery except biopsy operation, chemotherapy, immunotherapy and biological targeted therapy.
- Patients who have participated in other clinical trials within 1 month before the test.
- Patients estimated to have poor tolerance to induction chemotherapy.
- 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).
- Palliative treatment intent.
- Pregnant or lactating women.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China3 sites, 3 recruiting
- Not yet recruiting
Harbin Medical University Cancer Hospital
Harbin, Heilongjiang, 150000
Susheng Miao, PhD, 38898546@qq.com
- Not yet recruiting
Shandong Provincial ENT Hospital, Cheeloo College of Medicine, Shandong University
Jinan, Shandong, 250012
Zhenghua Lv, PhD, entlvzhenghua@163.com
- Recruiting
Eye & ENT Hospital, Fudan University
Shanghai, Shanghai Municipality, 200031
Ming Zhang, PhD, 8621-64377151, ent_zhm@126.com
About this study
Official title: The Management of Metastatic Neck Nodes in N2/3 Hypopharyngeal Squamous Cell Carcinoma: A Multi-center Randomized Controlled Prospective Study
This is a multi-center, multidisciplinary, open-label, randomized controlled prospective clinical study.
Read the detailed description
Hypopharyngeal squamous cell carcinoma (HPSCC) is prone to have regional metastasis, which is an established negative prognostic factor. Especially for N2/3 patients whose metastatic neck nodes are bulky and have multiple or extracapsular spreads, their survival outcome is even worse. Therefore, it is vital for clinicians to select proper treatment and further improve the prognosis of N2/3 HPSCC patients. The aim of this randomized controlled prospective study is to explore the suitable treatment strategy of metastatic neck nodes in N2/3 HPSCC. This study will enroll a total of 111 HPSCC patients, who are clinically classified as T1/2 N2/3 M0 stage and initially treated with surgery (group 1) or induction chemotherapy (group 2). For patients with the regional response of PR<50%/SD/PD after induction chemotherapy, their following treatment will be surgery for both the primary and regional sites. For patients with the regional response of CR/PR≥50%, the following treatment will be concomitant chemoradiotherapy for both the primary and regional sites.
- Conditions
- Hypopharyngeal Carcinoma
- Being tested
- Docetaxel, Cisplatin, Capecitabine, Concomitant chemoradiotherapy, Surgery
- Keywords
- Metastatic Neck Nodes, Induction Chemotherapy, Neck Dissection
- Medical subject headings
- Hypopharyngeal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DocetaxelDrug
60 mg/m2 i.v. day 1
CisplatinDrug
60 mg/m2 i.v. day 1-3
CapecitabineDrug
750 mg/m2 po bid day 1-14
Concomitant chemoradiotherapyRadiation
Radiotherapy: using intensity-modulated radiation therapy (IMRT)
Gross tumor volume (GTV) for primary tumor: 66-70 Gy in total, 2.0~2.2 Gy per day, 5 days per week
Clinical target volume (CTV) for lesions closely related to the primary lesion and metastatic lymph nodes: 65~70 Gy in total, 1.7~2.0 Gy per day, 5 days per week
Prophylactic irradiation for sites of suspected subclinical spread: 50~60 Gy in total, 1.7~2.0 Gy per day, 5 days per week
Concurrent chemotherapy: cisplatin 80 mg/m2 on days 1-3 every 3 weeks.
SurgeryProcedure or surgery
Neck dissection and primary tumor resection
| Study group | Role | What they receive |
|---|---|---|
| Induction chemotherapy group | Experimental | 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. Receives: Drug: Docetaxel; Drug: Cisplatin; Drug: Capecitabine; Radiation: Concomitant chemoradiotherapy; Procedure: Surgery |
| Surgery group | Active comparator | Patients initially receive surgery for both the primary and regional sites and postoperative concomitant chemoradiotherapy. Receives: Radiation: Concomitant chemoradiotherapy; Procedure: Surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free survival rate
The proportion of patients with disease progress or death due to any reasons.
Measured: 3 years
Secondary outcomes (6)
Overall survival rate
The proportion of dead patients due to any reasons.
Measured: 3 years
Local control
The proportion of patients with local recurrence.
Measured: 3 years
Regional control
The proportion of patients with regional recurrence.
Measured: 3 years
Metastasis-free survival
The proportion of patients with distant metastasis.
Measured: 3 years
Quality of life (UW-QOL V4.0)
Evaluated by University of Washington Quality of Life Questionnaire (UW-QOL) V4.0.
Measured: 3 years
Adverse events
Evaluated by the NCI Common Terminology Criteria for Adverse Events (NCI-CTCAE) V5.0.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2022
- Study start1 Nov 2022
- Primary completionNov 2027 (estimated)
- Study completionNov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hypopharyngeal CarcinomaStudies of the same condition, open and under way.
- More trials run by Eye & ENT Hospital of Fudan UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 111 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Eye & ENT Hospital of Fudan University
- Sponsor type
- University, hospital or other
- Collaborators
- Shandong Provincial Hospital, Harbin Medical University Third Affiliated Hospital
- Responsible party
- Principal investigator, Ming Zhang, Eye & ENT Hospital of Fudan University
- Investigators
- Ming Zhang, PhD, Principal investigator, Eye & ENT Hospital, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05494190
- Sponsor's protocol ID
- EENTHN0706
- Status last verified
- Dec 2025
- First submitted
- 6 Aug 2022
- Last updated
- 30 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Management of Metastatic Neck Nodes in N2/3 Hypopharyngeal Squamous Cell Carcinoma: A Multi-center Randomized Controlled Prospective Study
- ClinicalTrials.gov ID
- NCT05494190
- Acronym / sponsor ID
- EENTHN0706
- Conditions
- Hypopharyngeal Carcinoma
- Keywords
- Metastatic Neck Nodes, Induction Chemotherapy, Neck Dissection
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 111 participants (estimated)
- Lead sponsor
- Eye & ENT Hospital of Fudan UniversityUniversity, hospital or other
- Collaborators
- Shandong Provincial Hospital, Harbin Medical University Third Affiliated Hospital
- Study start
- 1 Nov 2022 (actual)
- Primary completion
- Nov 2027 (estimated)
- Study completion
- Nov 2027 (estimated)
- First posted
- 9 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a multi-center, multidisciplinary, open-label, randomized controlled prospective clinical study.
Detailed description
Hypopharyngeal squamous cell carcinoma (HPSCC) is prone to have regional metastasis, which is an established negative prognostic factor. Especially for N2/3 patients whose metastatic neck nodes are bulky and have multiple or extracapsular spreads, their survival outcome is even worse. Therefore, it is vital for clinicians to select proper treatment and further improve the prognosis of N2/3 HPSCC patients. The aim of this randomized controlled prospective study is to explore the suitable treatment strategy of metastatic neck nodes in N2/3 HPSCC. This study will enroll a total of 111 HPSCC patients, who are clinically classified as T1/2 N2/3 M0 stage and initially treated with surgery (group 1) or induction chemotherapy (group 2). For patients with the regional response of PR<50%/SD/PD after induction chemotherapy, their following treatment will be surgery for both the primary and regional sites. For patients with the regional response of CR/PR≥50%, the following treatment will be concomitant chemoradiotherapy for both the primary and regional sites.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Induction chemotherapy group | Experimental | Drug: Docetaxel, Drug: Cisplatin, Drug: Capecitabine, Radiation: Concomitant chemoradiotherapy, Procedure: SurgeryPatients 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. |
| Surgery group | Active comparator | Radiation: Concomitant chemoradiotherapy, Procedure: SurgeryPatients initially receive surgery for both the primary and regional sites and postoperative concomitant chemoradiotherapy. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Able to understand and willing to sign a written informed consent document.
- Age ≥ 18 and ≤ 75 years.
- Male or female.
- Karnofsky physical status (KPS): ≥ 80
- 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.
Key exclusion criteria (8 listed)
- Distant metastatic disease
- Have a history of other cancers or coinstantaneous second primary tumor
- Previous treatment for the primary tumor, including radiotherapy, surgery except biopsy operation, chemotherapy, immunotherapy and biological targeted therapy.
- Patients who have participated in other clinical trials within 1 month before the test.
- Patients estimated to have poor tolerance to induction chemotherapy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Docetaxel60 mg/m2 i.v. day 1 | Drug | Induction chemotherapy group |
| Cisplatin60 mg/m2 i.v. day 1-3 | Drug | Induction chemotherapy group |
| Capecitabine750 mg/m2 po bid day 1-14 | Drug | Induction chemotherapy group |
| Concomitant chemoradiotherapyRadiotherapy: using intensity-modulated radiation therapy (IMRT) Gross tumor volume (GTV) for primary tumor: 66-70 Gy in total, 2.0~2.2 Gy per day, 5 days per week Clinical target volume (CTV) for lesions closely related to the primary lesion and metastatic lymph nodes: 65~70 Gy in total, 1.7~2.0 Gy per day, 5 days per week Prophylactic irradiation for sites of suspected subclinical spread: 50~60 Gy in total, 1.7~2.0 Gy per day, 5 days per week Concurrent chemotherapy: cisplatin 80 mg/m2 on days 1-3 every 3 weeks. | Radiation | Induction chemotherapy group, Surgery group |
| SurgeryNeck dissection and primary tumor resection | Procedure or surgery | Induction chemotherapy group, Surgery group |
Primary outcome
Progression-free survival rate
Time frame: 3 years
The proportion of patients with disease progress or death due to any reasons.
6 secondary outcomes
Overall survival rate
Time frame: 3 years
Local control
Time frame: 3 years
Regional control
Time frame: 3 years
Metastasis-free survival
Time frame: 3 years
Quality of life (UW-QOL V4.0)
Time frame: 3 years
Adverse events
Time frame: 3 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Dec 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ming Zhang, PhD principal investigator
Eye & ENT Hospital, Fudan University
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Docetaxel, Cisplatin and Capecitabine in people with Hypopharyngeal Carcinoma, run by Eye & ENT Hospital of Fudan University at 3 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 30 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Feiran Li (8664377134, lifr214@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-free survival rate (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Dec 2025.