Hypopharyngeal CarcinomaNCT03367884
Neck Dissection vs Radiotherapy for Cervical Metastases in Advanced Hypopharyngeal Cancer
A study testing Neck dissection followed by radiotherapy(50Gy) according to risk factors and Definitive radiotherapy in people with Hypopharyngeal Carcinoma, run by Tianjin Medical University Cancer Institute and Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Hypopharyngeal Carcinoma
- What is being tested?
- Neck dissection followed by radiotherapy(50Gy) according to risk factors and Definitive radiotherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2018to 1 Jan 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 9Show fewer
- No serious disease history of the heart, liver, kidney, lung and other important organs
- Expected survival period≥ 12 months
- Good compliance
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Tianjin Medical University Cancer Institute and Hospital
Tianjin, Tianjin Municipality, 300000
Yuansheng Duan, MD, +86 022 23340123, duanyuansheng89@163.com
Ze Zhang, MD, +86 022 23340123, zhangze_smu@163.com
About this study
Official title: 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.
- Conditions
- Hypopharyngeal Carcinoma
- Being tested
- Neck dissection followed by radiotherapy(50Gy) according to risk factors, Definitive radiotherapy
- Keywords
- Hypopharyngeal cancer, Neck dissection, Induction chemotherapy, Cervical lymph node metastasis, definitive radiotherapy
- Medical subject headings
- Hypopharyngeal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neck dissection followed by radiotherapy(50Gy) according to risk factorsProcedure or surgery
Neck dissection followed by radiotherapy(50Gy) according to risk factors
Definitive radiotherapyRadiation
Definitive radiotherapy (70Gy)
| Study group | Role | What they receive |
|---|---|---|
| Neck dissection group | Experimental | Neck dissection followed by radiotherapy(50Gy) according to risk factors Receives: Procedure: Neck dissection followed by radiotherapy(50Gy) according to risk factors |
| Radiotherapy group | Active comparator | Definitive radiotherapy (70Gy) Receives: Radiation: Definitive radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neck control rates
The percentage of patients without cervical lymph node metastasis
Measured: 2 years
Secondary outcomes (8)
Disease-free survival
The proportion of patients did not find clear evidence of recurrence or metastasis
Measured: 1 year
Disease-free survival
The proportion of patients did not find clear evidence of recurrence or metastasis
Measured: 2 years
Disease-free survival
The proportion of patients did not find clear evidence of recurrence or metastasis
Measured: 3 years
Disease-free survival
The proportion of patients did not find clear evidence of recurrence or metastasis
Measured: 5 years
Overall survival
The proportion of patients who survived
Measured: 3 years
Overall survival
The proportion of patients who survived
Measured: 5 years
Quality of life(QOL) QLQ-C30
Evaluated by the European Organization for Research and Treatment of Cancer(EORTC)QLQ-C30
Measured: 1 year
Quality of life(QOL) QLQ-HN35
Evaluated by the European Organization for Research and Treatment of Cancer(EORTC) QLQ-HN35
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2017
- Study start1 Jan 2018 (estimated)
- Primary completion1 Jan 2024 (estimated)
- Study completion1 Jan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hypopharyngeal CarcinomaStudies of the same condition, open and under way.
- More trials run by Tianjin Medical University Cancer Institute and HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Tianjin Medical University Second Hospital, Tianjin Medical University General Hospital
- Responsible party
- Sponsor
- Investigators
- Xudong Wang, Ph.D, Principal investigator, Tianjin Medical University Cancer Institute and Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03367884
- Sponsor's protocol ID
- TJHPC-01
- Status last verified
- Nov 2017
- First submitted
- 5 Dec 2017
- Last updated
- 12 Dec 2017
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neck Dissection Versus Radiotherapy for Cervical Lymph Node Metastasis in Advanced Hypopharyngeal Carcinoma With Poor Response to Induction Chemotherapy : A Randomized Controlled Prospective Study
- ClinicalTrials.gov ID
- NCT03367884
- Acronym / sponsor ID
- TJHPC-01
- Conditions
- Hypopharyngeal Carcinoma
- Keywords
- Hypopharyngeal cancer, Neck dissection, Induction chemotherapy, Cervical lymph node metastasis, definitive radiotherapy
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Tianjin Medical University Cancer Institute and HospitalUniversity, hospital or other
- Collaborators
- Tianjin Medical University Second Hospital, Tianjin Medical University General Hospital
- Study start
- 1 Jan 2018 (estimated)
- Primary completion
- 1 Jan 2024 (estimated)
- Study completion
- 1 Jan 2028 (estimated)
- First posted
- 11 Dec 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Neck dissection group | Experimental | Procedure: Neck dissection followed by radiotherapy(50Gy) according to risk factorsNeck dissection followed by radiotherapy(50Gy) according to risk factors |
| Radiotherapy group | Active comparator | Radiation: Definitive radiotherapyDefinitive radiotherapy (70Gy) |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Neck dissection followed by radiotherapy(50Gy) according to risk factorsNeck dissection followed by radiotherapy(50Gy) according to risk factors | Procedure or surgery | Neck dissection group |
| Definitive radiotherapyDefinitive radiotherapy (70Gy) | Radiation | Radiotherapy group |
Primary outcome
Neck control rates
Time frame: 2 years
The percentage of patients without cervical lymph node metastasis
8 secondary outcomes
Disease-free survival
Time frame: 1 year
Disease-free survival
Time frame: 2 years
Disease-free survival
Time frame: 3 years
Disease-free survival
Time frame: 5 years
Overall survival
Time frame: 3 years
Overall survival
Time frame: 5 years
Quality of life(QOL) QLQ-C30
Time frame: 1 year
Quality of life(QOL) QLQ-HN35
Time frame: 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Xudong Wang, Ph.D principal investigator
Tianjin Medical University Cancer Institute and Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Neck dissection followed by radiotherapy(50Gy) according to risk factors and Definitive radiotherapy in people with Hypopharyngeal Carcinoma, run by Tianjin Medical University Cancer Institute and Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 12 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yuansheng Duan, MD (+86 022 23340123, duanyuansheng89@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Neck control rates (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Dec 2017.