Oral CancerPhase 4NCT03017053
The Optimal Neck Treatments Strategy of Early Oral Cancer Based on Adverse Pathological Factor
A Phase 4 study testing Radiotherapy and Elective neck dissection in people with Oral Cancer, run by Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University at 1 site in China.
Trial summary
Cervical nodal metastasis is the most certain prognostic factor in oral cancer. Appropriate management of the neck is therefore of paramount importance in the treatment of oral cancer. However, there is still some controversy on the treatment of early maxillofacial malignancies. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Oral Cancer
- What is being tested?
- Radiotherapy and Elective neck dissection
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 270 participants
- Where
- 1 siteChina
- Study dates
- Jul 2016to Jul 2025
- Phase
- Phase 4
- 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 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
- Clinical/ Histological/ cytological/ Imaging examination proven Oral/Oropharynx Squamous-cell carcinoma (Tongue, buccal mucosa, mouth floor, hard palate, Molar area), the depth of invasion > 4mm in preoperative assessment
- In line with clinical stage I / II stage (T1-2 N0 M0; AJCC 2010) and receiving surgical resection
- KPS≥ 70
- Normal bone marrow reserve function and normal liver, kidney function
- Expected survival period≥ 6 months
Who cannot join
- Inability to provide an informed consent
- Evidence of oral distant metastasis or other malignancies
- The patient has received prior surgery for primary tumor or lymph node ( except for biopsy )
- Prior radiotherapy for primary tumor
- The patient has previously received anti-tumor biological targeted therapy
- The patient has received chemotherapy or immunotherapy for primary tumors
Show all 17Show fewer
- Prior malignancy within the previous 5 years (except for cured skin basal cell carcinoma or cervical carcinoma in situ)
- With 3-4 grad Allergy to any drug in the treatment
- Peripheral neuropathy> 1 grade
- Any unstable systematic disease (including active infection, uncontrolled high blood pressure, unstable angina, onset of angina within the last 3 months, congestive heart failure, myocardial infarction within the previous 12 months, severe arrhythmia needing drug treatment, liver, kidney or metabolic disease)
- HIV positive
- Chronic diseases requiring immune agents or hormone therapy
- Pregnant or lactating women
- Drug/alcohol abuse, psychological or spiritual illness that may interfere compliance to the study
- Patients with epilepsy requiring medications (such as steroids or antiepileptic drugs)
- The patient has participated in other experimental therapy studies within 30 days
- Researchers believe that the situation is unsuitable for participation in the group
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Shanghai Ninth People's Hospital
Shanghai
Chenping ZHANG, Ph.D, +86-21-63136856, zhang.chenping@hotmail.com
About this study
Cervical nodal metastasis is the most certain prognostic factor in oral cancer. Appropriate management of the neck is therefore of paramount importance in the treatment of oral cancer. However, there is still some controversy on the treatment of early maxillofacial malignancies. Currently, investigators have no accurate uniform treatment standards, including the National Comprehensive Cancer Network (NCCN) recommended between surgery and radiotherapy options. Clinical evaluation indicated that lymph node-negative patients eventually 25%-35% had cervical node metastasis. Therefore, for the majority of patients with true node-negative, preventive cervical lymph node dissection is obviously over-treatment, and lower quality of life. Radiotherapy can avoid such surgery.
Read the detailed description
Objective: To evaluate the effect of radiotherapy on the neck of early oral cancer with poor pathologic factors.
This is a randomized, prospective, open, multicenter study. Intervention: Patients receive primary tumor resection followed by radiotherapy.
Control: Patients receive primary tumor resection with selective neck dissection.
Primary:
2 years neck control rates
Secondary:
Disease-free survival (1, 2, 3, 5 years) Overall survival (3, 5 years) Quality of life
Endpoint definition:
1 year, 2 years, 3 years, 5 years disease-free survival is defined as: patients proportion from the date of surgery completion to 1 year, 2 years, 3 years, 5 years did not find clear evidence of recurrence or metastasis.
3 years, 5 years overall survival is defined as: the proportion of patients who survived from the beginning of the study to the third and fifth year in the total enrollment.
- Conditions
- Oral Cancer
- Being tested
- Radiotherapy, Elective neck dissection
- Keywords
- Neck dissection, Survival, Early oral cancer, Early oral cavity squamous cancer with node negative neck
- Medical subject headings
- Mouth Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RadiotherapyRadiation
Radiotherapy after primary surgery in the treatment of early oral cancer based on adverse pathological factor
Elective neck dissectionProcedure or surgery
Elective neck dissection after primary surgery in the treatment of early oral cancer based on adverse pathological factor
| Study group | Role | What they receive |
|---|---|---|
| Radiotherapy | Experimental | Primary surgery \& Radiotherapy Receives: Radiation: Radiotherapy |
| Elective neck dissection | Active comparator | Primary surgery \& Elective neck dissection Receives: Procedure: Elective neck dissection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neck control rates
Measured: 2 years
Secondary outcomes (6)
Disease-free survival
Measured: 1 year
Disease-free survival
Measured: 2 years
Disease-free survival
Measured: 3 years
Disease-free survival
Measured: 5 years
Overall survival
Measured: 3 years
Overall survival
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2017 (estimated)
- Study startJul 2016
- Primary completionJul 2025 (estimated)
- Study completionJul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Oral 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 270 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chenping Zhang, Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
- Investigators
- Chenping ZHANG, Ph.D, Principal investigator, Shanghai Ninth People's Hospital Shanghai, China, 200011
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03017053
- Sponsor's protocol ID
- 15411950300
- Status last verified
- Jan 2017
- First submitted
- 9 Jan 2017
- Last updated
- 11 Jan 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Optimal Neck Treatments Strategy of Early Oral Cancer Based on Adverse Pathological Factor
- ClinicalTrials.gov ID
- NCT03017053
- Acronym / sponsor ID
- 15411950300
- Conditions
- Oral Cancer
- Keywords
- Neck dissection, Survival, Early oral cancer, Early oral cavity squamous cancer with node negative neck
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 270 participants (estimated)
- Lead sponsor
- Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong UniversityUniversity, hospital or other
- Study start
- Jul 2016
- Primary completion
- Jul 2025 (estimated)
- Study completion
- Jul 2025 (estimated)
- First posted
- 11 Jan 2017 (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.
Cervical nodal metastasis is the most certain prognostic factor in oral cancer. Appropriate management of the neck is therefore of paramount importance in the treatment of oral cancer. However, there is still some controversy on the treatment of early maxillofacial malignancies. Currently, investigators have no accurate uniform treatment standards, including the National Comprehensive Cancer Network (NCCN) recommended between surgery and radiotherapy options. Clinical evaluation indicated that lymph node-negative patients eventually 25%-35% had cervical node metastasis. Therefore, for the majority of patients with true node-negative, preventive cervical lymph node dissection is obviously over-treatment, and lower quality of life. Radiotherapy can avoid such surgery.
Detailed description
Objective: To evaluate the effect of radiotherapy on the neck of early oral cancer with poor pathologic factors.
This is a randomized, prospective, open, multicenter study. Intervention: Patients receive primary tumor resection followed by radiotherapy.
Control: Patients receive primary tumor resection with selective neck dissection.
Primary:
2 years neck control rates
Secondary:
Disease-free survival (1, 2, 3, 5 years) Overall survival (3, 5 years) Quality of life
Endpoint definition:
1 year, 2 years, 3 years, 5 years disease-free survival is defined as: patients proportion from the date of surgery completion to 1 year, 2 years, 3 years, 5 years did not find clear evidence of recurrence or metastasis.
3 years, 5 years overall survival is defined as: the proportion of patients who survived from the beginning of the study to the third and fifth year in the total enrollment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Radiotherapy | Experimental | Radiation: RadiotherapyPrimary surgery \& Radiotherapy |
| Elective neck dissection | Active comparator | Procedure: Elective neck dissectionPrimary surgery \& Elective neck dissection |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Ability to understand and the willingness to sign a written informed consent document
- Age≥ 18 and≤ 75 years
- Clinical/ Histological/ cytological/ Imaging examination proven Oral/Oropharynx Squamous-cell carcinoma (Tongue, buccal mucosa, mouth floor, hard palate, Molar area), the depth of invasion > 4mm in preoperative assessment
- In line with clinical stage I / II stage (T1-2 N0 M0; AJCC 2010) and receiving surgical resection
- KPS≥ 70
Key exclusion criteria (17 listed)
- Inability to provide an informed consent
- Evidence of oral distant metastasis or other malignancies
- The patient has received prior surgery for primary tumor or lymph node ( except for biopsy )
- Prior radiotherapy for primary tumor
- The patient has previously received anti-tumor biological targeted therapy
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 |
|---|---|---|
| RadiotherapyRadiotherapy after primary surgery in the treatment of early oral cancer based on adverse pathological factor | Radiation | Radiotherapy |
| Elective neck dissectionElective neck dissection after primary surgery in the treatment of early oral cancer based on adverse pathological factor | Procedure or surgery | Elective neck dissection |
Primary outcome
Neck control rates
Time frame: 2 years
6 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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jan 2017.
- Individual participant dataSharing planned: No
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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.
Chenping ZHANG, Ph.D principal investigator
Shanghai Ninth People's Hospital Shanghai, China, 200011
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Radiotherapy and Elective neck dissection in people with Oral Cancer, run by Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University 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 7 inclusion and 17 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 11 Jan 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 Chenping ZHANG, Ph.D (+86-21-63136856, zhang.chenping@hotmail.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 11 Jan 2017.