Neck Dissection vs Radiotherapy for Cervical Metastases in Advanced Hypopharyngeal Cancer

Neck Dissection Versus Radiotherapy for Cervical Lymph Node Metastasis in Advanced Hypopharyngeal Carcinoma With Poor Response to Induction Chemotherapy : A Randomized Controlled Prospective Study

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Hypopharyngeal Carcinoma
• Intervention / Treatment: Procedure: Neck dissection followed by radiotherapy(50Gy) according to risk factors; Radiation: Definitive radiotherapy

• Study Type: Interventional
• Enrollment (Anticipated): 120
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Yuansheng Duan, MD; Phone Number: +86 022 23340123; Email: duanyuansheng89@163.com

Study Locations

• China
  • Tianjin
    • Tianjin, Tianjin, China, 300000
      • Tianjin Medical University Cancer Institute and Hospital
      • Contact: Yuansheng Duan, MD; Phone Number: +86 022 23340123; Email: duanyuansheng89@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Neck dissection group; Neck dissection followed by radiotherapy(50Gy) according to risk factors	Procedure: Neck dissection followed by radiotherapy(50Gy) according to risk factors; Neck dissection followed by radiotherapy(50Gy) according to risk factors
ACTIVE_COMPARATOR: Radiotherapy group; Definitive radiotherapy (70Gy)	Radiation: Definitive radiotherapy; Definitive radiotherapy (70Gy)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Neck control rates	The percentage of patients without cervical lymph node metastasis	2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Disease-free survival	The proportion of patients did not find clear evidence of recurrence or metastasis	1 year
Disease-free survival	The proportion of patients did not find clear evidence of recurrence or metastasis	2 years
Disease-free survival	The proportion of patients did not find clear evidence of recurrence or metastasis	3 years
Disease-free survival	The proportion of patients did not find clear evidence of recurrence or metastasis	5 years
Overall survival	The proportion of patients who survived	3 years
Overall survival	The proportion of patients who survived	5 years
Quality of life(QOL) QLQ-C30	Evaluated by the European Organization for Research and Treatment of Cancer(EORTC)QLQ-C30	1 year
Quality of life(QOL) QLQ-HN35	Evaluated by the European Organization for Research and Treatment of Cancer(EORTC) QLQ-HN35	1 year

Collaborators and Investigators

• Sponsor: Tianjin Medical University Cancer Institute and Hospital
• Collaborators: Tianjin Medical University General Hospital; Tianjin Medical University Second Hospital
• Investigators: Principal Investigator: Xudong Wang, Ph.D, Tianjin Medical University Cancer Institute and Hospital

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): January 1, 2018
• Primary Completion (ANTICIPATED): January 1, 2024
• Study Completion (ANTICIPATED): January 1, 2028

Study Registration Dates

• First Submitted: December 5, 2017
• First Submitted That Met QC Criteria: December 5, 2017
• First Posted (ACTUAL): December 11, 2017

Study Record Updates

• Last Update Posted (ACTUAL): December 12, 2017
• Last Update Submitted That Met QC Criteria: December 10, 2017
• Last Verified: November 1, 2017

More Information

Terms related to this study

• Keywords: Induction chemotherapy; definitive radiotherapy; Neck dissection; Hypopharyngeal cancer; Cervical lymph node metastasis
• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Neoplasms, Glandular and Epithelial; Pharyngeal Neoplasms; Otorhinolaryngologic Neoplasms; Head and Neck Neoplasms; Pharyngeal Diseases; Stomatognathic Diseases; Otorhinolaryngologic Diseases; Neoplastic Processes; Carcinoma; Neoplasm Metastasis; Hypopharyngeal Neoplasms
• Other Study ID Numbers: TJHPC-01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No