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Neck Dissection vs Radiotherapy for Cervical Metastases in Advanced Hypopharyngeal Cancer

NCT03367884 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2017-12-12

No results posted yet for this study

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.

Conditions

  • Hypopharyngeal Carcinoma

Interventions

PROCEDURE

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

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

RADIATION

Definitive radiotherapy

Definitive radiotherapy (70Gy)

Sponsors & Collaborators

  • Tianjin Medical University Second Hospital

    collaborator OTHER

  • Tianjin Medical University General Hospital

    collaborator OTHER

  • Tianjin Medical University Cancer Institute and Hospital

    lead OTHER

Principal Investigators

  • Xudong Wang, Ph.D · Tianjin Medical University Cancer Institute and Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-01-01
Primary Completion
2024-01-01
Completion
2028-01-01

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03367884 on ClinicalTrials.gov