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Not yet recruitingNCT03367884Updated Dec 12, 2017

Neck Dissection vs Radiotherapy for Cervical Metastases in Advanced Hypopharyngeal Cancer

An interventional study of Neck dissection followed by radiotherapy(50Gy) according to risk factors and Definitive radiotherapy in Hypopharyngeal Carcinoma, sponsored by Tianjin Medical University Cancer Institute and Hospital. Not yet recruiting at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2017-12-12.

Sponsored by Tianjin Medical University Cancer Institute and Hospital · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Jan 2024, 2 years 10 months ago, but the record still lists the study as not yet recruiting.

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Phase
Not applicable
Study type
Interventional
Enrollment
120
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-13

Among 21 studies in Hypopharyngeal Neoplasms with a site in China — 16 open to participants now, 17 under way, 2 of them phase 3. Hypopharyngeal Neoplasms · China.

Planned enrollment
3rd of 19
120 · median 63
Started
2018
the only one that year
No phase
4 of 21
3 open now
Primary completion
2024-01
later than 2 of 16 live
Registered
3rd of 21
by date

Among the 21 studies in Hypopharyngeal Neoplasms with a site in China, this one is the 3rd largest by planned enrollment of the 19 interventional ones that give a count, is the only one that started in 2018, is one of 4 with no phase, reaches primary completion later than 2 of the 16 other live ones, and was the 3rd registered.

Hypopharyngeal Neoplasms

148 studies on the registry are indexed under Hypopharyngeal Neoplasms; 45 are open to participants now.

Browse Hypopharyngeal Neoplasms studies →

Open to participants now

16 of the 21 studies in Hypopharyngeal Neoplasms with a site in China are open now. Recruiting first, the newest first:

10 more — sign in →

All 16 open studies →

A study can be open while its sites in China have not opened yet or have stopped. Only those recruiting at a site in China →

Who these studies take

Of the 38 Hypopharyngeal Neoplasms studies recruiting now, 23 (61%) set no upper age limit and 8 (21%) stop at 75 or younger; none take children under 18; 2 take healthy volunteers.

This study: 18 Years to 75 Years · all sexes · no healthy volunteers.

The full table on the hub →

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02

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.

03

Conditions studied

  • Hypopharyngeal Carcinoma

Keywords

  • Hypopharyngeal cancer
  • Neck dissection
  • Induction chemotherapy
  • Cervical lymph node metastasis
  • definitive radiotherapy
04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Ability to understand and the willingness to sign a written 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 cervical lymph node more than 2cm in diameter
  5. EPOG≤1,≥ 70
  6. No 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

Exclusion Criteria:

  1. Inability to provide an
  2. Other 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 )
  5. The patient has received chemotherapy or immunotherapy
  6. Pregnant or lactating women
  7. Other disease requiring simultaneous surgery or radiotherapy
Terms in these criteria, in plain language(6)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Metastases

Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.

Karnofsky performance status (KPS)

A 0–100 scale of how well someone can carry out everyday activities. 100 is no complaints and no signs of illness; 70 is able to look after yourself but not to work or keep up normal activity; 50 is needing considerable help and frequent medical care.

Studies often ask for 60 or 70 and above. Your doctor gives the score.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

Biopsy and archival tissue

A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.

Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
120 participants (estimated)

Study arms

  • 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

  • Active comparator
    Radiotherapy group

    Definitive radiotherapy (70Gy)

    Radiation: Definitive radiotherapy

Interventions

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

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

  • RadiationDefinitive radiotherapy

    Definitive radiotherapy (70Gy)

06

What researchers measure

Primary outcomes

  1. Neck control rates

    The percentage of patients without cervical lymph node metastasis

    Time frame: 2 years

Secondary outcomes

  1. Disease-free survival

    The proportion of patients did not find clear evidence of recurrence or metastasis

    Time frame: 1 year

  2. Disease-free survival

    The proportion of patients did not find clear evidence of recurrence or metastasis

    Time frame: 2 years

  3. Disease-free survival

    The proportion of patients did not find clear evidence of recurrence or metastasis

    Time frame: 3 years

  4. Disease-free survival

    The proportion of patients did not find clear evidence of recurrence or metastasis

    Time frame: 5 years

  5. Overall survival

    The proportion of patients who survived

    Time frame: 3 years

  6. Overall survival

    The proportion of patients who survived

    Time frame: 5 years

  7. Quality of life(QOL) QLQ-C30

    Evaluated by the European Organization for Research and Treatment of Cancer(EORTC)QLQ-C30

    Time frame: 1 year

  8. Quality of life(QOL) QLQ-HN35

    Evaluated by the European Organization for Research and Treatment of Cancer(EORTC) QLQ-HN35

    Time frame: 1 year

07

Study locations

1 site
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Start is estimated for Jan 2018; primary completion for Jan 2024, 72 months later.

How these figures are worked out, and which studies are left out of them.

Registered
Dec 5, 2017
First posted
Dec 11, 2017
StartEst.
Jan 1, 2018
Primary completionEst.
Jan 1, 2024
CompletionEst.
Jan 1, 2028
Last update
Dec 12, 2017
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Dec 12, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT03367884
Collaborators
Tianjin Medical University Second Hospital, Tianjin Medical University General Hospital
Responsible party
Sponsor
First posted
Dec 11, 2017
Start date
Jan 1, 2018 (estimated)
Primary completion
Jan 1, 2024 (estimated)
Completion
Jan 1, 2028 (estimated)
Last update
Dec 12, 2017

Study contacts

Yuansheng Duan, MD
Contact
duanyuansheng89@163.com
+86 022 23340123
Ze Zhang, MD
Contact
zhangze_smu@163.com
+86 022 23340123
Xudong Wang, Ph.D
principal investigator · Tianjin Medical University Cancer Institute and Hospital

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Nov 2017. You cannot join it, but the record below documents what was studied.

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Discussion

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