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Neck Dissection vs Radiotherapy for Cervical Metastases in Advanced Hypopharyngeal Cancer

Primary Purpose

Hypopharyngeal Carcinoma

Status
Not yet recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Neck dissection followed by radiotherapy(50Gy) according to risk factors
Definitive radiotherapy
Sponsored by
Tianjin Medical University Cancer Institute and Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypopharyngeal Carcinoma focused on measuring Hypopharyngeal cancer, Neck dissection, Induction chemotherapy, Cervical lymph node metastasis, definitive radiotherapy

Eligibility Criteria

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

Inclusion Criteria:

  1. Ability to understand and the willingness to sign a written informed consent document
  2. Age≥ 18 and≤ 75 years
  3. Histological/ cytological/ Imaging examination proven hypopharyngeal squamous-cell carcinoma in preoperative assessment
  4. Advanced hypopharyngeal cancer with metastatic cervical lymph node more than 2cm in diameter
  5. EPOG≤1,KPS≥ 70
  6. No contraindication of surgery and radiotherapy
  7. No serious disease history of the heart, liver, kidney, lung and other important organs
  8. Expected survival period≥ 12 months
  9. Good compliance

Exclusion Criteria:

  1. Inability to provide an informed consent
  2. Other malignancy tumor history,(except for cured skin basal cell carcinoma and papillary thyroid carcinoma)
  3. Serious cardiovascular, liver, respiratory, kidney and neurologic and psychiatric disease with clinical symptoms
  4. The patient has received prior surgery or radiotherapy (except for biopsy)
  5. The patient has received chemotherapy or immunotherapy
  6. Pregnant or lactating women
  7. Other disease requiring simultaneous surgery or radiotherapy

Sites / Locations

  • Tianjin Medical University Cancer Institute and Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Neck dissection group

Radiotherapy group

Arm Description

Neck dissection followed by radiotherapy(50Gy) according to risk factors

Definitive radiotherapy (70Gy)

Outcomes

Primary Outcome Measures

Neck control rates
The percentage of patients without cervical lymph node metastasis

Secondary Outcome Measures

Disease-free survival
The proportion of patients did not find clear evidence of recurrence or metastasis
Disease-free survival
The proportion of patients did not find clear evidence of recurrence or metastasis
Disease-free survival
The proportion of patients did not find clear evidence of recurrence or metastasis
Disease-free survival
The proportion of patients did not find clear evidence of recurrence or metastasis
Overall survival
The proportion of patients who survived
Overall survival
The proportion of patients who survived
Quality of life(QOL) QLQ-C30
Evaluated by the European Organization for Research and Treatment of Cancer(EORTC)QLQ-C30
Quality of life(QOL) QLQ-HN35
Evaluated by the European Organization for Research and Treatment of Cancer(EORTC) QLQ-HN35

Full Information

First Posted
December 5, 2017
Last Updated
December 10, 2017
Sponsor
Tianjin Medical University Cancer Institute and Hospital
Collaborators
Tianjin Medical University Second Hospital, Tianjin Medical University General Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03367884
Brief Title
Neck Dissection vs Radiotherapy for Cervical Metastases in Advanced Hypopharyngeal Cancer
Official Title
Neck Dissection Versus Radiotherapy for Cervical Lymph Node Metastasis in Advanced Hypopharyngeal Carcinoma With Poor Response to Induction Chemotherapy : A Randomized Controlled Prospective Study
Study Type
Interventional

2. Study Status

Record Verification Date
November 2017
Overall Recruitment Status
Not yet recruiting
Study Start Date
January 1, 2018 (Anticipated)
Primary Completion Date
January 1, 2024 (Anticipated)
Study Completion Date
January 1, 2028 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Tianjin Medical University Cancer Institute and Hospital
Collaborators
Tianjin Medical University Second Hospital, Tianjin Medical University General Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
At the time of diagnosis, approximately 60%-80% of patients with hypopharyngeal cancer are found with cervical lymph node metastasis. Cervical nodal metastasis is an important prognostic factor in hypopharyngeal cancer. Induction chemotherapy is frequently used in advanced hypopharynx cancer. However, sometimes CR was obtained at the tumor's primary site but not in the palpable lymph nodes in the neck, the large cervical lymph node metastasis poorly responded to induction chemotherapy in a considerable percentage of patients. At present, patients with primary tumor achieved CR preferred to receive definitive radiotherapy no matter cervical lymph node metastasis SD or progression. But, radiotherapy was poor effective to the big cervical lymph node metastasis, because the inner of big cervical lymph node metastasis was hypoxic and necrosis. The investigators conducted a prospective, randomised trial to compare neck dissection with definitive radiotherapy for advanced hypopharyngeal cancer cervical lymph node metastasis with poor response to induction chemotherapy.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypopharyngeal Carcinoma
Keywords
Hypopharyngeal cancer, Neck dissection, Induction chemotherapy, Cervical lymph node metastasis, definitive radiotherapy

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Neck dissection group
Arm Type
Experimental
Arm Description
Neck dissection followed by radiotherapy(50Gy) according to risk factors
Arm Title
Radiotherapy group
Arm Type
Active Comparator
Arm Description
Definitive radiotherapy (70Gy)
Intervention Type
Procedure
Intervention Name(s)
Neck dissection followed by radiotherapy(50Gy) according to risk factors
Intervention Description
Neck dissection followed by radiotherapy(50Gy) according to risk factors
Intervention Type
Radiation
Intervention Name(s)
Definitive radiotherapy
Intervention Description
Definitive radiotherapy (70Gy)
Primary Outcome Measure Information:
Title
Neck control rates
Description
The percentage of patients without cervical lymph node metastasis
Time Frame
2 years
Secondary Outcome Measure Information:
Title
Disease-free survival
Description
The proportion of patients did not find clear evidence of recurrence or metastasis
Time Frame
1 year
Title
Disease-free survival
Description
The proportion of patients did not find clear evidence of recurrence or metastasis
Time Frame
2 years
Title
Disease-free survival
Description
The proportion of patients did not find clear evidence of recurrence or metastasis
Time Frame
3 years
Title
Disease-free survival
Description
The proportion of patients did not find clear evidence of recurrence or metastasis
Time Frame
5 years
Title
Overall survival
Description
The proportion of patients who survived
Time Frame
3 years
Title
Overall survival
Description
The proportion of patients who survived
Time Frame
5 years
Title
Quality of life(QOL) QLQ-C30
Description
Evaluated by the European Organization for Research and Treatment of Cancer(EORTC)QLQ-C30
Time Frame
1 year
Title
Quality of life(QOL) QLQ-HN35
Description
Evaluated by the European Organization for Research and Treatment of Cancer(EORTC) QLQ-HN35
Time Frame
1 year

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: Ability to understand and the willingness to sign a written informed consent document Age≥ 18 and≤ 75 years Histological/ cytological/ Imaging examination proven hypopharyngeal squamous-cell carcinoma in preoperative assessment Advanced hypopharyngeal cancer with metastatic cervical lymph node more than 2cm in diameter EPOG≤1,KPS≥ 70 No contraindication of surgery and radiotherapy No serious disease history of the heart, liver, kidney, lung and other important organs Expected survival period≥ 12 months Good compliance Exclusion Criteria: Inability to provide an informed consent Other malignancy tumor history,(except for cured skin basal cell carcinoma and papillary thyroid carcinoma) Serious cardiovascular, liver, respiratory, kidney and neurologic and psychiatric disease with clinical symptoms The patient has received prior surgery or radiotherapy (except for biopsy) The patient has received chemotherapy or immunotherapy Pregnant or lactating women Other disease requiring simultaneous surgery or radiotherapy
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yuansheng Duan, MD
Phone
+86 022 23340123
Email
duanyuansheng89@163.com
First Name & Middle Initial & Last Name or Official Title & Degree
Ze Zhang, MD
Phone
+86 022 23340123
Email
zhangze_smu@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xudong Wang, Ph.D
Organizational Affiliation
Tianjin Medical University Cancer Institute and Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Tianjin Medical University Cancer Institute and Hospital
City
Tianjin
State/Province
Tianjin
ZIP/Postal Code
300000
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yuansheng Duan, MD
Phone
+86 022 23340123
Email
duanyuansheng89@163.com
First Name & Middle Initial & Last Name & Degree
Ze Zhang, MD
Phone
+86 022 23340123
Email
zhangze_smu@163.com
First Name & Middle Initial & Last Name & Degree
Xudong Wang, Ph.D

12. IPD Sharing Statement

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Neck Dissection vs Radiotherapy for Cervical Metastases in Advanced Hypopharyngeal Cancer

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