NCT03367884

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.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
20mo left

Started Jan 2018

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress83%
Jan 2018Jan 2028

First Submitted

Initial submission to the registry

December 5, 2017

Completed
6 days until next milestone

First Posted

Study publicly available on registry

December 11, 2017

Completed
21 days until next milestone

Study Start

First participant enrolled

January 1, 2018

Completed
6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2024

Completed
4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2028

Expected
Last Updated

December 12, 2017

Status Verified

November 1, 2017

Enrollment Period

6 years

First QC Date

December 5, 2017

Last Update Submit

December 10, 2017

Conditions

Hypopharyngeal Carcinoma

Keywords

Hypopharyngeal cancerNeck dissectionInduction chemotherapyCervical lymph node metastasisdefinitive radiotherapy

Outcome Measures

Primary Outcomes (1)

  • Neck control rates

    The percentage of patients without cervical lymph node metastasis

    2 years

Secondary Outcomes (8)

  • Disease-free survival

    1 year

  • Disease-free survival

    2 years

  • Disease-free survival

    3 years

  • Disease-free survival

    5 years

  • Overall survival

    3 years

  • +3 more secondary outcomes

Study Arms (2)

Neck dissection group

EXPERIMENTAL

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

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

Radiotherapy group

ACTIVE COMPARATOR

Definitive radiotherapy (70Gy)

Radiation: Definitive radiotherapy

Interventions

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

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

Neck dissection group
Definitive radiotherapyRADIATION

Definitive radiotherapy (70Gy)

Radiotherapy group

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tianjin Medical University Cancer Institute and Hospital

Tianjin, Tianjin Municipality, 300000, China

Location

MeSH Terms

Conditions

Hypopharyngeal Neoplasms

Condition Hierarchy (Ancestors)

Pharyngeal NeoplasmsOtorhinolaryngologic NeoplasmsHead and Neck NeoplasmsNeoplasms by SiteNeoplasmsPharyngeal DiseasesStomatognathic DiseasesOtorhinolaryngologic Diseases

Study Officials

  • Xudong Wang, Ph.D

    Tianjin Medical University Cancer Institute and Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Yuansheng Duan, MD

CONTACT

+86 022 23340123duanyuansheng89@163.com

Ze Zhang, MD

CONTACT

+86 022 23340123zhangze_smu@163.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 5, 2017

First Posted

December 11, 2017

Study Start

January 1, 2018

Primary Completion

January 1, 2024

Study Completion (Estimated)

January 1, 2028

Last Updated

December 12, 2017

Record last verified: 2017-11

Locations

CN(1)