Trial Title:
The Management of Metastatic Neck Nodes in N2/3 Hypopharyngeal Squamous Cell Carcinoma
NCT ID:
NCT05494190
Condition:
Hypopharyngeal Carcinoma
Conditions: Official terms:
Carcinoma
Carcinoma, Squamous Cell
Squamous Cell Carcinoma of Head and Neck
Docetaxel
Capecitabine
Conditions: Keywords:
Metastatic Neck Nodes
Induction Chemotherapy
Neck Dissection
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Docetaxel
Description:
60 mg/m2 i.v. day 1
Arm group label:
Induction chemotherapy group
Intervention type:
Drug
Intervention name:
Cisplatin
Description:
60 mg/m2 i.v. day 1-3
Arm group label:
Induction chemotherapy group
Intervention type:
Drug
Intervention name:
Capecitabine
Description:
750 mg/m2 po bid day 1-14
Arm group label:
Induction chemotherapy group
Intervention type:
Radiation
Intervention name:
Concomitant chemoradiotherapy
Description:
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.
Arm group label:
Induction chemotherapy group
Arm group label:
Surgery group
Intervention type:
Procedure
Intervention name:
Surgery
Description:
Neck dissection and primary tumor resection
Arm group label:
Induction chemotherapy group
Arm group label:
Surgery group
Summary:
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.
Criteria for eligibility:
Criteria:
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.
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Harbin Medical University Cancer Hospital
Address:
City:
Harbin
Zip:
150000
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Susheng Miao, PhD
Email:
38898546@qq.com
Facility:
Name:
Shandong Provincial ENT Hospital, Cheeloo College of Medicine, Shandong University
Address:
City:
Jinan
Zip:
250012
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Zhenghua Lv, PhD
Email:
entlvzhenghua@163.com
Facility:
Name:
Eye & ENT Hospital, Fudan University
Address:
City:
Shanghai
Zip:
200031
Country:
China
Status:
Recruiting
Contact:
Last name:
Ming Zhang, PhD
Phone:
8621-64377151
Email:
ent_zhm@126.com
Start date:
November 1, 2022
Completion date:
November 2025
Lead sponsor:
Agency:
Eye & ENT Hospital of Fudan University
Agency class:
Other
Collaborator:
Agency:
Shandong Provincial Hospital
Agency class:
Other
Collaborator:
Agency:
Harbin Medical University Third Affiliated Hospital
Agency class:
Other
Source:
Eye & ENT Hospital of Fudan University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05494190
