search
Back to results

The Management of Metastatic Neck Nodes in N2/3 Hypopharyngeal Squamous Cell Carcinoma

Primary Purpose

Hypopharyngeal Carcinoma

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Docetaxel
Cisplatin
Capecitabine
Concomitant chemoradiotherapy
Surgery
Sponsored by
Eye & ENT Hospital of Fudan University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypopharyngeal Carcinoma focused on measuring Metastatic Neck Nodes, Induction Chemotherapy, Neck Dissection

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Harbin Medical University Cancer Hospital
  • Shandong Provincial ENT Hospital, Cheeloo College of Medicine, Shandong University
  • Eye & ENT Hospital, Fudan UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Induction chemotherapy group

Surgery group

Arm 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.

Patients initially receive surgery for both the primary and regional sites and postoperative concomitant chemoradiotherapy.

Outcomes

Primary Outcome Measures

Progression-free survival rate
The proportion of patients with disease progress or death due to any reasons.

Secondary Outcome Measures

Overall survival rate
The proportion of dead patients due to any reasons.
Local control
The proportion of patients with local recurrence.
Regional control
The proportion of patients with regional recurrence.
Metastasis-free survival
The proportion of patients with distant metastasis.
Quality of life (UW-QOL V4.0)
Evaluated by University of Washington Quality of Life Questionnaire (UW-QOL) V4.0.
Adverse events
Evaluated by the NCI Common Terminology Criteria for Adverse Events (NCI-CTCAE) V5.0.

Full Information

First Posted
August 6, 2022
Last Updated
April 17, 2023
Sponsor
Eye & ENT Hospital of Fudan University
Collaborators
Shandong Provincial Hospital, Harbin Medical University Third Affiliated Hospital
search

1. Study Identification

Unique Protocol Identification Number
NCT05494190
Brief Title
The Management of Metastatic Neck Nodes in N2/3 Hypopharyngeal Squamous Cell Carcinoma
Official Title
The Management of Metastatic Neck Nodes in N2/3 Hypopharyngeal Squamous Cell Carcinoma: A Multi-center Randomized Controlled Prospective Study
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 1, 2022 (Actual)
Primary Completion Date
November 2025 (Anticipated)
Study Completion Date
November 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Eye & ENT Hospital of Fudan University
Collaborators
Shandong Provincial Hospital, Harbin Medical University Third Affiliated Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypopharyngeal Carcinoma
Keywords
Metastatic Neck Nodes, Induction Chemotherapy, Neck Dissection

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
111 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Induction chemotherapy group
Arm Type
Experimental
Arm 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.
Arm Title
Surgery group
Arm Type
Active Comparator
Arm Description
Patients initially receive surgery for both the primary and regional sites and postoperative concomitant chemoradiotherapy.
Intervention Type
Drug
Intervention Name(s)
Docetaxel
Intervention Description
60 mg/m2 i.v. day 1
Intervention Type
Drug
Intervention Name(s)
Cisplatin
Intervention Description
60 mg/m2 i.v. day 1-3
Intervention Type
Drug
Intervention Name(s)
Capecitabine
Intervention Description
750 mg/m2 po bid day 1-14
Intervention Type
Radiation
Intervention Name(s)
Concomitant chemoradiotherapy
Intervention 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.
Intervention Type
Procedure
Intervention Name(s)
Surgery
Intervention Description
Neck dissection and primary tumor resection
Primary Outcome Measure Information:
Title
Progression-free survival rate
Description
The proportion of patients with disease progress or death due to any reasons.
Time Frame
3 years
Secondary Outcome Measure Information:
Title
Overall survival rate
Description
The proportion of dead patients due to any reasons.
Time Frame
3 years
Title
Local control
Description
The proportion of patients with local recurrence.
Time Frame
3 years
Title
Regional control
Description
The proportion of patients with regional recurrence.
Time Frame
3 years
Title
Metastasis-free survival
Description
The proportion of patients with distant metastasis.
Time Frame
3 years
Title
Quality of life (UW-QOL V4.0)
Description
Evaluated by University of Washington Quality of Life Questionnaire (UW-QOL) V4.0.
Time Frame
3 years
Title
Adverse events
Description
Evaluated by the NCI Common Terminology Criteria for Adverse Events (NCI-CTCAE) V5.0.
Time Frame
3 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. 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. Exclusion Criteria: 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Feiran Li
Phone
8621-64377151
Email
lifr214@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ming Zhang, PhD
Organizational Affiliation
Eye & ENT Hospital, Fudan University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Harbin Medical University Cancer Hospital
City
Harbin
State/Province
Heilongjiang
ZIP/Postal Code
150000
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Susheng Miao, PhD
Email
38898546@qq.com
Facility Name
Shandong Provincial ENT Hospital, Cheeloo College of Medicine, Shandong University
City
Jinan
State/Province
Shandong
ZIP/Postal Code
250012
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zhenghua Lv, PhD
Email
entlvzhenghua@163.com
Facility Name
Eye & ENT Hospital, Fudan University
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200031
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ming Zhang, PhD
Phone
8621-64377151
Email
ent_zhm@126.com

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

The Management of Metastatic Neck Nodes in N2/3 Hypopharyngeal Squamous Cell Carcinoma

We'll reach out to this number within 24 hrs