Oropharynx CarcinomaNCT05341479
An Observational Study of Clinical Treatments for Patients With Oropharyngeal Carcinoma
An observational study of Oropharynx Carcinoma, run by Eye & ENT Hospital of Fudan University at 1 site in China.
Trial summary
This is a prospective, observational study evaluating the effect and efficiency of different clinical treatments for patients with oropharyngeal carcinoma (OPC). The selection of treatment for individual patient is based on tumor characteristics (tumor size and tumor location), a complete assessment of therapeutic… Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Oropharynx Carcinoma
- What is being tested?
- Surgery for early-stage OPC, RT for early-stage OPC and CRT for advanced OPC
- Type of treatment
- Surgery or procedure
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 1 Apr 2022to 1 Jul 2025
- Phase
- Observational
- 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 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: This prospective, observational study involves patients with T1-T4 stages oropharyngeal carcinoma, and we aim to evaluate and compare the oncological outcomes of different clinical treatments in patients with same TNM stage disease, overall and stratified by HPV expression. Demographic and clinicopathological characteristics of patients enrolled are also collected to assess their associations with treatment strategies and prognoses.
Who may be able to join
- Oropharyngeal cancer: Base of Tongue/Tonsil/Posterior Pharyngeal Wall/Soft Palate;
- T1, T2, T3, and T4 stage.
- Age 18 - 90.
- Male or female.
- Good compliance.
- No other severe related diseases that may impact the treatment (such as other tumors, severe heart, lung and central nervous system diseases, etc.).
- Negative pregnancy test (for female patients with fertility).
- Male patients with fertility and female patients with fertility and pregnancy risk must agree to use contraceptive methods throughout the study period, and continued until at least 6 months after the last dose of cisplatin. Female patients do not have fertility. Female patients with postmenopausal status.
Who cannot join
- Patients who have previously been diagnosed with immunodeficiency or known human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS)-related diseases.
- Patients with a known history of active tuberculosis (TB).
- Pregnant women or lactating women.
- The doctors believes that it is inappropriate for patients to participate in the trial: having, for example, severe acute or chronic medical conditions (including immune colitis, inflammatory bowel disease, non-infectious pneumonia, pulmonary fibrosis) or mental illness (including recent time [within the past year] or active suicidal ideation or behavior).
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Department of Otorhinolaryngology, Eye & ENT Hospital
Shanghai, Shanghai Municipality, 200031
Lei Tao, Dr., +86 2164377134, doctortaolei@163.com
About this study
Official title: Department of Otorhinolaryngology, Eye & ENT Hospital
This is a prospective, observational study evaluating the effect and efficiency of different clinical treatments for patients with oropharyngeal carcinoma (OPC). The selection of treatment for individual patient is based on tumor characteristics (tumor size and tumor location), a complete assessment of therapeutic effects (treatment effectiveness, possible dysfunction after operation, function maintenance, complications, etc.), and the preferences of doctors and patients.
Read the detailed description
For early-stage oropharyngeal carcinoma (T1-2,N0), radiotherapy or resection of the primary tumor (transoral laser microsurgery, transoral robotic surgery, conventional transoral surgery, and open surgery) with ipsilateral or bilateral neck dissection are performed according to the guidelines of Chinese society of clinical oncology (CSCO, version 2021) and the NCCN guidelines (version 2021). Postoperative radiotherapy (RT) or chemoradiotherapy (CRT) should be considered for patients with adverse features (e.g., extranodal extension, positive margins, perineural invasion or vascular invasion).
For advanced oropharyngeal carcinoma (T1-2,N1-3/T3-4,N0-3), chemoradiotherapy (CRT), resection of the primary tumor (transoral robotic surgery, conventional transoral surgery, transoral laser microsurgery, and open surgery) with ipsilateral or bilateral neck dissection or neoadjuvant therapy with appropriate therapy (surgical resection, RT or CRT) are performed according to the CSCO guidelines (version 2021) and the NCCN guidelines (version 2021). Postoperative radiotherapy (RT) or chemoradiotherapy (CRT) should be considered for patients with adverse features (e.g., pT3 or pT4 primary, pN2 or pN3 nodal disease, extranodal extension, positive margins, perineural invasion or vascular invasion).
This study aims to evaluate and compare the clinical outcomes of different medical treatments in patients with same TNM stage disease, overall and stratified by HPV expression. Demographic and clinicopathological characteristics of patients enrolled were also collected to assess their associations with treatment strategies and prognoses. The rates of overall survival, disease specific survival, disease free survival, local control, regional control, and progress-free survival are analyzed in the present study.
- Conditions
- Oropharynx Carcinoma
- Being tested
- Surgery for early-stage OPC, RT for early-stage OPC, CRT for advanced OPC, Surgery for advanced OPC, Neoadjuvant treatment for advanced OPC
- Keywords
- Oropharynx carcinoma, Treatment, Survival outcomes
- Medical subject headings
- Oropharyngeal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Surgery for early-stage OPCProcedure or surgery
The treatment strategy for patients should be discussed by the multidisciplinary team with the goal of maximizing survival with preservation of appearance and function and planned based on the tumor extension as ascertained by clinical evaluation and careful interpretation of appropriate imaging examinations.
Early-stage OPC patients (T1-2,N0) enrolled in this group will be treated with surgical resection. The surgical techniques of the primary tumor include transoral robotic surgery, conventional transoral surgery, transoral laser microsurgery (e.g., CO2 laser resection), and open surgery. Ipsilateral neck dissection should be performed for patients enrolled in this group. For patients with OPC at or approaching the midline, bilateral neck dissection should be strongly considered.
Postoperative radiotherapy (RT) or system therapy/RT should be considered for patients with adverse features (e.g., extranodal extension, perineural invasion or vascular invasion).
RT for early-stage OPCRadiation
The treatment strategy for patients should be discussed by the multidisciplinary team with the goal of maximizing survival with preservation of appearance and function and planned based on the tumor extension as ascertained by clinical evaluation and careful interpretation of appropriate imaging examinations.
Early-stage OPC patients (T1-2,N0) enrolled in this group will be treated with RT.
CRT for advanced OPCRadiation
The treatment strategy for patients should be discussed by the multidisciplinary team with the goal of maximizing survival with preservation of appearance and function and planned based on the tumor extension as ascertained by clinical evaluation and careful interpretation of appropriate imaging examinations.
Advanced OPC patients (T1-2,N1-3/T3-4,N0-3) enrolled in this group will be treated with CRT.
Surgery for advanced OPCOther
The treatment strategy for patients should be discussed by the multidisciplinary team with the goal of maximizing survival with preservation of appearance and function and planned based on the tumor extension as ascertained by clinical evaluation and careful interpretation of appropriate imaging examinations.
Advanced OPC patients (T1-2,N1-3/T3-4,N0-3) enrolled in this group will be treated with surgical resection. The surgical techniques of the primary tumor include transoral robotic surgery, conventional transoral surgery, transoral laser microsurgery, and open surgery. Ipsilateral neck dissection should be performed for patients enrolled in this group. For patients with OPC at or approaching the midline, bilateral neck dissection should be strongly considered.
Postoperative radiotherapy (RT) or system therapy/RT should be considered for patients with adverse features (e.g., pT3 or pT4 primary, pN2 or pN3 nodal disease, extranodal extension, or vascular invasion).
Neoadjuvant treatment for advanced OPCProcedure or surgery
The treatment strategy for patients should be discussed by the multidisciplinary team with the goal of maximizing survival with preservation of appearance and function and planned based on the tumor extension as ascertained by clinical evaluation and careful interpretation of appropriate imaging examinations.
Advanced OPC patients (T1-2,N1-3/T3-4,N0-3) enrolled in this group will be treated with neoadjuvant treatment. The subsequent treatments include RT, system therapy/RT, and surgical resection with or without postoperative adjuvant therapy.
| Study group | Role | What they receive |
|---|---|---|
| Surgical treatment for early-stage OPC | Early-stage OPC patients treated with surgery according to proper indications (CSCO 2021 and NCCN 2021). Receives: Procedure: Surgery for early-stage OPC | |
| RT treatment for early-stage OPC | Early-stage OPC patients treated with radiotherapy (RT) according to proper indications (CSCO 2021 and NCCN 2021). Receives: Radiation: RT for early-stage OPC | |
| CRT treatment for advanced OPC | Advanced OPC patients treated with chemoradiotherapy (CRT) according to proper indications (CSCO 2021 and NCCN 2021). Receives: Radiation: CRT for advanced OPC | |
| Surgical treatment for advanced OPC | Advanced OPC patients treated with surgery according to proper indications (CSCO 2021 and NCCN 2021). Receives: Other: Surgery for advanced OPC | |
| Neoadjuvant treatment for advanced OPC | Advanced OPC patients treated with neoadjuvant treatment according to proper indications (CSCO 2021 and NCCN 2021). Receives: Procedure: Neoadjuvant treatment for advanced OPC |
What is being measured
The primary outcome is the main question the study is designed to answer.
3-year overall survival
The time between the treatment and the date of death from any causes
Measured: Three years
Secondary outcomes (6)
3-year local control survival
The time between the treatment and the first evidence of local recurrence
Measured: Three years
3-year regional control
The time between the treatment and the first evidence of regional recurrence
Measured: Three years
3-year disease specific survival
The time between the treatment and the date of death from oropharyngeal cancer
Measured: Three years
3-year disease free survival
The time between the treatment and the first evidence of disease recurrence, metastasis or death from any cause
Measured: Three years
3-year progress-free survival
The time between the treatment and the date of first documented disease progression or death from any cause
Measured: Three years
Quality of Life post treatment
Quality of life as assessed with the MD Anderson Dysphagia Inventory (MDADI)
Measured: One year and three years post treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2022
- Study start1 Apr 2022
- Primary completion31 Mar 2025 (estimated)
- Study completion1 Jul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Oropharynx CarcinomaStudies of the same condition, open and under way.
- More trials run by Eye & ENT Hospital of Fudan 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Eye & ENT Hospital of Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, LeiTao, Eye & ENT Hospital of Fudan University
- Investigators
- Lei Tao, Dr., Study chair, Department of Otorhinolaryngology, Eye & ENT Hospital, Fudan University, Shanghai, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05341479
- Sponsor's protocol ID
- FD-EENT-2022036
- Status last verified
- Apr 2022
- First submitted
- 18 Apr 2022
- Last updated
- 22 Apr 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Department of Otorhinolaryngology, Eye & ENT Hospital
- ClinicalTrials.gov ID
- NCT05341479
- Acronym / sponsor ID
- FD-EENT-2022036
- Conditions
- Oropharynx Carcinoma
- Keywords
- Oropharynx carcinoma, Treatment, Survival outcomes
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Eye & ENT Hospital of Fudan UniversityUniversity, hospital or other
- Study start
- 1 Apr 2022 (actual)
- Primary completion
- 31 Mar 2025 (estimated)
- Study completion
- 1 Jul 2025 (estimated)
- First posted
- 22 Apr 2022 (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.
This is a prospective, observational study evaluating the effect and efficiency of different clinical treatments for patients with oropharyngeal carcinoma (OPC). The selection of treatment for individual patient is based on tumor characteristics (tumor size and tumor location), a complete assessment of therapeutic effects (treatment effectiveness, possible dysfunction after operation, function maintenance, complications, etc.), and the preferences of doctors and patients.
Detailed description
For early-stage oropharyngeal carcinoma (T1-2,N0), radiotherapy or resection of the primary tumor (transoral laser microsurgery, transoral robotic surgery, conventional transoral surgery, and open surgery) with ipsilateral or bilateral neck dissection are performed according to the guidelines of Chinese society of clinical oncology (CSCO, version 2021) and the NCCN guidelines (version 2021). Postoperative radiotherapy (RT) or chemoradiotherapy (CRT) should be considered for patients with adverse features (e.g., extranodal extension, positive margins, perineural invasion or vascular invasion).
For advanced oropharyngeal carcinoma (T1-2,N1-3/T3-4,N0-3), chemoradiotherapy (CRT), resection of the primary tumor (transoral robotic surgery, conventional transoral surgery, transoral laser microsurgery, and open surgery) with ipsilateral or bilateral neck dissection or neoadjuvant therapy with appropriate therapy (surgical resection, RT or CRT) are performed according to the CSCO guidelines (version 2021) and the NCCN guidelines (version 2021). Postoperative radiotherapy (RT) or chemoradiotherapy (CRT) should be considered for patients with adverse features (e.g., pT3 or pT4 primary, pN2 or pN3 nodal disease, extranodal extension, positive margins, perineural invasion or vascular invasion).
This study aims to evaluate and compare the clinical outcomes of different medical treatments in patients with same TNM stage disease, overall and stratified by HPV expression. Demographic and clinicopathological characteristics of patients enrolled were also collected to assess their associations with treatment strategies and prognoses. The rates of overall survival, disease specific survival, disease free survival, local control, regional control, and progress-free survival are analyzed in the present study.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Surgical treatment for early-stage OPC | – | Procedure: Surgery for early-stage OPCEarly-stage OPC patients treated with surgery according to proper indications (CSCO 2021 and NCCN 2021). |
| RT treatment for early-stage OPC | – | Radiation: RT for early-stage OPCEarly-stage OPC patients treated with radiotherapy (RT) according to proper indications (CSCO 2021 and NCCN 2021). |
| CRT treatment for advanced OPC | – | Radiation: CRT for advanced OPCAdvanced OPC patients treated with chemoradiotherapy (CRT) according to proper indications (CSCO 2021 and NCCN 2021). |
| Surgical treatment for advanced OPC | – | Other: Surgery for advanced OPCAdvanced OPC patients treated with surgery according to proper indications (CSCO 2021 and NCCN 2021). |
| Neoadjuvant treatment for advanced OPC | – | Procedure: Neoadjuvant treatment for advanced OPCAdvanced OPC patients treated with neoadjuvant treatment according to proper indications (CSCO 2021 and NCCN 2021). |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This prospective, observational study involves patients with T1-T4 stages oropharyngeal carcinoma, and we aim to evaluate and compare the oncological outcomes of different clinical treatments in patients with same TNM stage disease, overall and stratified by HPV expression. Demographic and clinicopathological characteristics of patients enrolled are also collected to assess their associations with treatment strategies and prognoses.
Key inclusion criteria (8 listed)
- Oropharyngeal cancer: Base of Tongue/Tonsil/Posterior Pharyngeal Wall/Soft Palate;
- T1, T2, T3, and T4 stage.
- Age 18 - 90.
- Male or female.
- Good compliance.
Key exclusion criteria (4 listed)
- Patients who have previously been diagnosed with immunodeficiency or known human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS)-related diseases.
- Patients with a known history of active tuberculosis (TB).
- Pregnant women or lactating women.
- The doctors believes that it is inappropriate for patients to participate in the trial: having, for example, severe acute or chronic medical conditions (including immune colitis, inflammatory bowel disease, non-infectious pneumonia, pulmonary fibrosis) or mental illness (including recent time [within the past year] or active suicidal ideation or behavior).
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 |
|---|---|---|
| Surgery for early-stage OPCThe treatment strategy for patients should be discussed by the multidisciplinary team with the goal of maximizing survival with preservation of appearance and function and planned based on the tumor extension as ascertained by clinical evaluation and careful interpretation of appropriate imaging examinations. Early-stage OPC patients (T1-2,N0) enrolled in this group will be treated with surgical resection. The surgical techniques of the primary tumor include transoral robotic surgery, conventional transoral surgery, transoral laser microsurgery (e.g., CO2 laser resection), and open surgery. Ipsilateral neck dissection should be performed for patients enrolled in this group. For patients with OPC at or approaching the midline, bilateral neck dissection should be strongly considered. Postoperative radiotherapy (RT) or system therapy/RT should be considered for patients with adverse features (e.g., extranodal extension, perineural invasion or vascular invasion). | Procedure or surgery | Surgical treatment for early-stage OPC |
| RT for early-stage OPCThe treatment strategy for patients should be discussed by the multidisciplinary team with the goal of maximizing survival with preservation of appearance and function and planned based on the tumor extension as ascertained by clinical evaluation and careful interpretation of appropriate imaging examinations. Early-stage OPC patients (T1-2,N0) enrolled in this group will be treated with RT. | Radiation | RT treatment for early-stage OPC |
| CRT for advanced OPCThe treatment strategy for patients should be discussed by the multidisciplinary team with the goal of maximizing survival with preservation of appearance and function and planned based on the tumor extension as ascertained by clinical evaluation and careful interpretation of appropriate imaging examinations. Advanced OPC patients (T1-2,N1-3/T3-4,N0-3) enrolled in this group will be treated with CRT. | Radiation | CRT treatment for advanced OPC |
| Surgery for advanced OPCThe treatment strategy for patients should be discussed by the multidisciplinary team with the goal of maximizing survival with preservation of appearance and function and planned based on the tumor extension as ascertained by clinical evaluation and careful interpretation of appropriate imaging examinations. Advanced OPC patients (T1-2,N1-3/T3-4,N0-3) enrolled in this group will be treated with surgical resection. The surgical techniques of the primary tumor include transoral robotic surgery, conventional transoral surgery, transoral laser microsurgery, and open surgery. Ipsilateral neck dissection should be performed for patients enrolled in this group. For patients with OPC at or approaching the midline, bilateral neck dissection should be strongly considered. Postoperative radiotherapy (RT) or system therapy/RT should be considered for patients with adverse features (e.g., pT3 or pT4 primary, pN2 or pN3 nodal disease, extranodal extension, or vascular invasion). | Other | Surgical treatment for advanced OPC |
| Neoadjuvant treatment for advanced OPCThe treatment strategy for patients should be discussed by the multidisciplinary team with the goal of maximizing survival with preservation of appearance and function and planned based on the tumor extension as ascertained by clinical evaluation and careful interpretation of appropriate imaging examinations. Advanced OPC patients (T1-2,N1-3/T3-4,N0-3) enrolled in this group will be treated with neoadjuvant treatment. The subsequent treatments include RT, system therapy/RT, and surgical resection with or without postoperative adjuvant therapy. | Procedure or surgery | Neoadjuvant treatment for advanced OPC |
Primary outcome
3-year overall survival
Time frame: Three years
The time between the treatment and the date of death from any causes
6 secondary outcomes
3-year local control survival
Time frame: Three years
3-year regional control
Time frame: Three years
3-year disease specific survival
Time frame: Three years
3-year disease free survival
Time frame: Three years
3-year progress-free survival
Time frame: Three years
Quality of Life post treatment
Time frame: One year and three years post treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2022.
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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.
Lei Tao, Dr. study chair
Department of Otorhinolaryngology, Eye & ENT Hospital, Fudan University, Shanghai, China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Oropharynx Carcinoma, run by Eye & ENT Hospital of Fudan 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 8 inclusion and 4 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 22 Apr 2022. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lei Tao, Dr. (+86 2164377134, doctortaolei@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
3-year overall survival (time frame: Three 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 22 Apr 2022.