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Neck Dissection vs Radiotherapy for Cervical Metastases in Advanced Hypopharyngeal Cancer

NCT ID: NCT03367884

Last Updated: 2017-12-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-01-01

Study Completion Date

2028-01-01

Brief Summary

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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.

Detailed Description

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Conditions

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Hypopharyngeal Carcinoma

Keywords

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Hypopharyngeal cancer Neck dissection Induction chemotherapy Cervical lymph node metastasis definitive radiotherapy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Neck dissection group

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

Group Type EXPERIMENTAL

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

Intervention Type PROCEDURE

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

Radiotherapy group

Definitive radiotherapy (70Gy)

Group Type ACTIVE_COMPARATOR

Definitive radiotherapy

Intervention Type RADIATION

Definitive radiotherapy (70Gy)

Interventions

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

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

Intervention Type PROCEDURE

Definitive radiotherapy

Definitive radiotherapy (70Gy)

Intervention Type RADIATION

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Tianjin Medical University Second Hospital

OTHER

Sponsor Role collaborator

Tianjin Medical University General Hospital

OTHER

Sponsor Role collaborator

Tianjin Medical University Cancer Institute and Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Xudong Wang, Ph.D

Role: PRINCIPAL_INVESTIGATOR

Tianjin Medical University Cancer Institute and Hospital

Locations

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Tianjin Medical University Cancer Institute and Hospital

Tianjin, Tianjin Municipality, China

Site Status

Countries

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China

Central Contacts

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Yuansheng Duan, MD

Role: CONTACT

Phone: +86 022 23340123

Email: [email protected]

Ze Zhang, MD

Role: CONTACT

Phone: +86 022 23340123

Email: [email protected]

Facility Contacts

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Yuansheng Duan, MD

Role: primary

Ze Zhang, MD

Role: backup

Other Identifiers

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TJHPC-01

Identifier Type: -

Identifier Source: org_study_id