Head-and-neck CancerPhase 2NCT02764216
Elective Mucosal Irradiation in Head-and-Neck Cancer of Unknown Primary
A Phase 2 study testing Elective mucosal irradiaton in people with Head-and-neck Cancer and Carcinoma of Unknown Primary, run by Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University at 2 sites in China.
Trial summary
The optimal treatment of HNCUP remains controversial and lacks evidence from prospective randomized trials. The management of these patients relies primarily on surgery and radiotherapy. The role of radiotherapy in sterilizing putative mucosal sites remains controversial. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Head-and-neck Cancer, Carcinoma of Unknown Primary
- What is being tested?
- Elective mucosal irradiaton
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 2 sitesChina
- Study dates
- Jan 2010to Dec 2020
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Carcinomas metastatic to cervical lymph node with unknown primary
- Squamous cell carcinoma, poorly differentiated carcinoma, or undifferentiated carcinoma
- All patients must be suitable to attend regular follow-up and undergo toxicity assessment.
- Stage T0, N1-3, M0 disease
- Karnofsky score over 60
- No significant cardiac, chest, gastrointestinal or renal morbidities
Who cannot join
- Previous radiotherapy to the head and neck region
- Previous malignancy except non-melanoma skin cancer
- Previous or concurrent illness which in the investigators opinion would interfere with either completion of therapy or follow-up
Trial locations and contacts
2 sites in 1 country.
Guopei Zhu, M.D. contact
China2 sites, 2 recruiting
- Recruiting
Shanghai ninth people's hospital
Shanghai, Shanghai Municipality, 200011
Guopei Zhu, M.D.
- Recruiting
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, 200032
Guopei Zhu, M.D., +8621 6417 5590, antica@gmail.com
Guopei Zhu, M.D.
About this study
Official title: Elective Mucosal Irradiation in Head-and Neck Cancer of Unknown Primary, A Single Arm Phase II Trial
The optimal treatment of HNCUP remains controversial and lacks evidence from prospective randomized trials. The management of these patients relies primarily on surgery and radiotherapy. The role of radiotherapy in sterilizing putative mucosal sites remains controversial. The main debate concerns the extent of the radiation field. Although pan-mucosal irradiation from the nasopharynx to the hypopharynx and bilateral neck nodes reduces the risk of emergence of a mucosal primary or a nodal relapse, it has been associated with significant toxicity and long-term morbidity (mostly xerostomia and dysphagia). Most single institution retrospective studies have not shown any advantage for more extensive irradiation.Therefore, elective mucosal irradiation may might be appropriate only for these patients.
- Conditions
- Head-and-neck Cancer, Carcinoma of Unknown Primary
- Being tested
- Elective mucosal irradiaton
- Medical subject headings
- Head and Neck Neoplasms, Neoplasms, Unknown Primary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Elective mucosal irradiatonRadiation
Patients will elective mucosal irradiaton based on nodal station, EBV/HPV status, RPN status etc. IMRT will be adopted.
| Study group | Role | What they receive |
|---|---|---|
| EMI group | Experimental | Elective mucosal irradiation Receives: Radiation: Elective mucosal irradiaton |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mucosal recurrence free survival
from date of enrollment to date of first documented primary site emergence or death, assessed up to 3 years.
Measured: 3 years
Secondary outcomes (4)
Disease-free survival
from date of enrollment until date of first documented disease progression or death from any cause, assessed up to 3 years.
Measured: 3 years
Neck control rate
from date of enrollment until date of first documented neck relapse, assessed up to 3 years.
Measured: 3 years
overall survival rate
from date of enrollment until date of first death from any cause, assessed up to 3 years.
Measured: 3 years
Acute toxicities(gastrointestinal toxicities,hematologic toxicities, dysphagia,oral mucositis)
Acute toxicities(gastrointestinal toxicities,hematologic toxicities, dysphagia,oral mucositis) during the course of radiotherapy
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2016 (estimated)
- Study startJan 2010
- Primary completionJan 2020 (estimated)
- Study completionDec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Head-and-neck CancerStudies of the same condition, open and under way.
- More trials run by Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong UniversityThe 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Shanghai Jiao Tong University School of Medicine
- Responsible party
- Principal investigator, Guopei Zhu, Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02764216
- Sponsor's protocol ID
- 1501160-4
- Status last verified
- Apr 2019
- First submitted
- 4 May 2016
- Last updated
- 9 Apr 2019
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Publications
Dou S, Li R, Zhang L, Wang Z, Xie L, Zhang C, Zhu G. Long-term results of elective mucosal irradiation for head and neck cancer of unknown primary in Chinese population: The EMICUP study. Cancer Med. 2020 Mar;9(5):1712-1720. doi: 10.1002/cam4.2856. Epub 2020 Jan 17.
PubMed 31953927
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Elective Mucosal Irradiation in Head-and Neck Cancer of Unknown Primary, A Single Arm Phase II Trial
- ClinicalTrials.gov ID
- NCT02764216
- Acronym / sponsor ID
- 1501160-4
- Conditions
- Head-and-neck Cancer, Carcinoma of Unknown Primary
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong UniversityUniversity, hospital or other
- Collaborators
- Shanghai Jiao Tong University School of Medicine
- Study start
- Jan 2010 (actual)
- Primary completion
- Jan 2020 (estimated)
- Study completion
- Dec 2020 (estimated)
- First posted
- 6 May 2016 (estimated)
- 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.
The optimal treatment of HNCUP remains controversial and lacks evidence from prospective randomized trials. The management of these patients relies primarily on surgery and radiotherapy. The role of radiotherapy in sterilizing putative mucosal sites remains controversial. The main debate concerns the extent of the radiation field. Although pan-mucosal irradiation from the nasopharynx to the hypopharynx and bilateral neck nodes reduces the risk of emergence of a mucosal primary or a nodal relapse, it has been associated with significant toxicity and long-term morbidity (mostly xerostomia and dysphagia). Most single institution retrospective studies have not shown any advantage for more extensive irradiation.Therefore, elective mucosal irradiation may might be appropriate only for these patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| EMI group | Experimental | Radiation: Elective mucosal irradiatonElective mucosal irradiation |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Carcinomas metastatic to cervical lymph node with unknown primary
- Squamous cell carcinoma, poorly differentiated carcinoma, or undifferentiated carcinoma
- All patients must be suitable to attend regular follow-up and undergo toxicity assessment.
- Stage T0, N1-3, M0 disease
- Karnofsky score over 60
Key exclusion criteria (3 listed)
- Previous radiotherapy to the head and neck region
- Previous malignancy except non-melanoma skin cancer
- Previous or concurrent illness which in the investigators opinion would interfere with either completion of therapy or follow-up
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 |
|---|---|---|
| Elective mucosal irradiatonPatients will elective mucosal irradiaton based on nodal station, EBV/HPV status, RPN status etc. IMRT will be adopted. | Radiation | EMI group |
Primary outcome
Mucosal recurrence free survival
Time frame: 3 years
from date of enrollment to date of first documented primary site emergence or death, assessed up to 3 years.
4 secondary outcomes
Disease-free survival
Time frame: 3 years
Neck control rate
Time frame: 3 years
overall survival rate
Time frame: 3 years
Acute toxicities(gastrointestinal toxicities,hematologic toxicities, dysphagia,oral mucositis)
Time frame: 2 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2019.
- Derived from this study: PubMed 31953927Dou S, Li R, Zhang L, Wang Z, Xie L, Zhang C, Zhu G. Long-term results of elective mucosal irradiation for head and neck cancer of unknown primary in Chinese population: The EMICUP study. Cancer Med. 2020 Mar;9(5):1712-1720. doi: 10.1002/cam4.2856. Epub 2020 Jan 17.
- Individual participant dataSharing planned: Undecided
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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. This study is not recruiting at the moment.
Guopei Zhu, M.D. contact
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Elective mucosal irradiaton in people with Head-and-neck Cancer and Carcinoma of Unknown Primary, run by Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University at 2 sites 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 6 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 9 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Guopei Zhu, M.D. (antica@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mucosal recurrence free survival (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02764216, which also lists 1 linked publication.
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 9 Apr 2019.