Head and Neck Squamous Cell CarcinomaPhase 2NEOSNCT05294900
Trial of Neoadjuvant Therapy With Paclitaxel and Carboplatin in Operable Locally Advanced Head and Neck Cancer Patients
A Phase 2 study testing paclitaxel/carboplatin in people with Head and Neck Squamous Cell Carcinoma, run by Yonsei University at 1 site in South Korea.
Trial summary
Objective: Primary objective: To evaluate the major pathologic response (mPR) of locally advanced head and neck cancer after paclitaxel and carboplatin-induction chemotherapy followed by surgery. Secondary objective: To evaluate the efficacy and safety of induction chemotherapy. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Head and Neck Squamous Cell Carcinoma
- What is being tested?
- paclitaxel/carboplatin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 79 participants
- Where
- 1 siteSouth Korea
- Study dates
- 26 May 2023to 22 Oct 2025
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- A patient whose potentially surgical, teletransfer-free HNSCC of oral, hypodermic, occipital, and larynx has been tissue-confirmed Oral cancer of III-IV, laryngeal cancer, hypodermic cancer, HPV-negative head cancer II-III HPV positive head cancer
- A disease that can be measured, defined as a lesion that can be accurately measured pursuant to RECIST 1.1
- Where the candidate subject to the test prepares the consent of the person subject to the test after obtaining approval required by region before the commencement of any plan-related procedures, including screening evaluation
- Adult men and women over 20 years old at the time of participation in clinical trials
- Eastern Cancer Cooperation Research Group (Eastern Cooperative Oncology Group, ECOG) Activity Status 0 or 1
- A patient with a life expectancy of at least 12 weeks
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- Proper and normal organ and bone marrow functions as defined below:
- hemoglobin test 9.0 g/dL
- Absolute neutropenic number (ANC) set 109/L (1500 per mm3)
- Platelet count 75,000 per mm3
- 1.5 times the total ULN of serum biliubine test institution
- 2.5 times the ULN of the AST (SGOT)/ALT (SGPT) test institute.
- Creatinine cleaning rate measured by 24-hour urine collection samples > 40 mL/min or calculated by Cockcroft Gault formula (Cockcroft and Gault 1976) >40 mL/min:
- Women who have evidence after menopause or pre-menopausal women whose urine or serum pregnancy test results are negative. Women who have amenorrhea for 12 months without other medical reasons are considered after menopause. The following age requirements apply:
- Even under the age of 50, she is in amenorrhea for at least 12 months after discontinuing exogenous hormone treatment, and if the LH and FSH levels are the menopause levels of the test institute, or if she underwent a surgical infertility operation (bilateral ovarian resection or complete hysterectomy), she is considered a menopause woman.
- Women who have been in amenorrhea for at least 12 months after stopping all external hormone treatment, or whose last menstrual period is at least a year before and after radiation-induced menopause, or more than a year after chemotherapy induced menopause or who have undergone surgical infertility (bilateral ovarian resection, bilateral tubulectomy, or full hysterectomy) are considered women with menopause.
Who cannot join
- Direct involvement in the planning and/or implementation of this clinical trial
- Patients with nasopharyngeal cancer
- A patient who has experienced previous treatment for head and neck cancer (including a history of radiation treatment)
- Patients who have participated in other clinical trials using clinical drugs within the past month
- A patient registered simultaneously in a clinical trial other than an observation (non-mediate) clinical trial or an intermediary clinical trial tracer
- Patients who need to use additional chemotherapy, clinical medicine, biological medicine, or hormone therapy for chemotherapy: Provided, That the simultaneous use of hormone therapy (e.g. hormone replacement therapy) for conditions unrelated to cancer is allowed.
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- The toxicity of at least NCI CTCAE Level 2 of the previous anti-cancer treatment, which has not yet been resolved: Provided, That laboratory values defined as hair loss, vitiligo, and selection criteria shall be excluded.
- Neuropathy of grade 2 or higher is determined after consultation with a clinical trial doctor on a case-by-case basis.
- Patients with irreversible toxicity that is not expected to worsen due to the administration of clinical trials can participate in the test only after consultation with a clinical trial doctor.
- Patients who undergo a major operation (according to the tester's definition) within 28 days before the initial administration of clinical medication. Note: Local surgery on independent lesions for the purpose of conventional treatment is acceptable.
- Intractable diseases, but not limited to the following: ongoing or active infections; symptom congestive heart failure; uncontrolled high blood pressure; unstable angina; heart veins; epileptic lung disease; Major chronic gastrointestinal conditions with diarrhea; All mental/social conditions that may restrict compliance with clinical trial requirements or significantly increase the risk of adverse reactions or hinder the subject's ability to write consent
- A patient who has a history of another primary malignant tumor: Provided, That the following shall not apply:
- A past malignant tumor that was treated for the purpose of complete cure and has no history of a known active disease within five years before the initial administration of clinical medication and has a low risk of recurrence
- non-black skin cancer treated properly or malignant black spots without evidence of disease
- Carcinoma that has been properly treated and has no evidence of disease
- History of active primary immune deficiency
- Women who are currently pregnant or breastfeeding or fertile men and women who are not willing to use effective contraception from the time of screening to 180 days after the end of clinical treatment
- Patients who are known to be allergic or irritable to clinical trials drugs or their siblings
- Patients who are not suitable to participate in clinical trials and are not expected to comply with clinical trial procedures, restrictions, and requirements according to the judgment of the tester
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Yonsei University Health System, Severance Hospital
Seoul
About this study
Official title: Phase II Trial of Neoadjuvant Therapy With Paclitaxel and Carboplatin in Operable Locally Advanced Head and Neck Cancer Patients (NEOS)
- Objective: Primary objective: To evaluate the major pathologic response (mPR) of locally advanced head and neck cancer after paclitaxel and carboplatin-induction chemotherapy followed by surgery.
Secondary objective: To evaluate the efficacy and safety of induction chemotherapy. Outcome metrics: Local relapse rate (LRR), Relapse-free survival (RFS), Overall survival (OS), Adverse reactions according to CTCAE 5.0 Exploratory Purpose: To evaluate changes in circulating tumor cells (CTC) and immunodynamics before and after paclitaxel and carboplatin-induction chemotherapy through blood, biopsy specimens, and surgical specimen analysis.
- background :
- Chemoradiation (CRT) or chemotherapy (Induction Chemotherapy (IC) + CRT) after induction chemotherapy has been performed for locally advanced head and neck cancer that cannot be operated immediately or for organ function preservation. .
- The efficacy of induction chemotherapy before chemotherapy has been controversial because the results of several phase 3 clinical studies are inconsistent. At present, it is difficult to assert the superiority of either the addition of induction chemotherapy or radiation therapy alone, but in certain subgroups (advanced N stage such as N2c/N3) induction chemotherapy is a useful option to lower distant metastases. I can do it.
- As a result of the TAX324 clinical trial, when weekly carboplatin-based chemotherapy or surgery was performed after adjuvant Docetaxel + Cisplatin + 5FU chemotherapy, overall survival was improved compared to Cisplatin + 5FU (HR 0.7, p=0.0058), It resulted in improvement of institutional retention rate (3 year LFS: 52% vs 32%). However, it is difficult to apply this TPF therapy to all patients in actual clinical practice due to the toxicity (neutropenia, nephrotoxicity) and the limitation of anticancer radiation.
- In a retrospective study, in the case of adjuvant paclitaxel + carboplatin, there was no difference in progression-free survival compared to TPF (p=0.15), and there was no statistically significant decrease in the local recurrence rate (HR 0.27, p = 0.04). Confirmed.
- Therefore, in this study, when paclitaxel and carboplatin-induction chemotherapy followed by surgery and chemotherapy after surgery, compared to standard TPF-induced chemotherapy, it is expected that the clinical outcome will be improved with less toxicity.
- Hypothesis: Paclitaxel and carboplatin-induction chemotherapy followed by surgery, followed by chemo-radiation after surgery according to standard guidelines Compared with the existing standard treatment (TCF), improvement of clinical outcome with less toxicity
- Study procedure
- Induction chemotherapy Paclitaxel 175mg/m2 + Carboplatin AUC5 (calculated by Cockcroft - Gault formula) Combination therapy A total of 2 intravenous infusions every 3 weeks Surgery performed within 2-9 weeks after induction chemotherapy
- surgery The surgery in this study means a complete resection for the purpose of a complete cure, and aims for a minimally invasive surgery.
Read the detailed description
- Induction chemotherapy Paclitaxel 175mg/m2 + Carboplatin AUC5 (calculated by Cockcroft - Gault formula) Combination therapy A total of 2 intravenous infusions every 3 weeks"
- Conditions
- Head and Neck Squamous Cell Carcinoma
- Being tested
- paclitaxel/carboplatin
- Keywords
- HNSCC, Neo-adjuvant chemotherapy
- Medical subject headings
- Squamous Cell Carcinoma of Head and Neck
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
paclitaxel/carboplatinDrug
Induction chemotherapy : total 2 cycle every 3weeks as below:
- Paclitaxel 175mg/m2
- Carboplatin AUC5
| Study group | Role | What they receive |
|---|---|---|
| paclitaxel/carboplatin | Experimental | paclitaxel+carboplatin Receives: Drug: paclitaxel/carboplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Major Pathologic Response
Major Pathologic Response (MPR) was defined as ≤10% residual viable tumor cells in the resected primary tumor specimen following completion of two cycles of neoadjuvant paclitaxel-carboplatin chemotherapy. Pathologic evaluation was performed by two independent board-certified pathologists in a blinded manner. MPR reflects the extent of tumor regression induced by neoadjuvant therapy and serves as a key indicator of treatment efficacy in resectable head and neck squamous cell carcinoma.
Measured: At the time of surgery following two cycles of neoadjuvant paclitaxel-carboplatin chemotherapy (approximately 6-9 weeks after treatment initiation).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2022
- Study start26 May 2023
- Primary completion22 Oct 2025
- Study completion22 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Head and Neck Squamous Cell CarcinomaStudies of the same condition, open and under way.
- More trials run by Yonsei 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
- 79 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chang Gon Kim, Yonsei University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05294900
- Sponsor's protocol ID
- 4-2022-0130
- Acronym
- NEOS
- Status last verified
- May 2026
- First submitted
- 15 Mar 2022
- Last updated
- 26 May 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Trial of Neoadjuvant Therapy With Paclitaxel and Carboplatin in Operable Locally Advanced Head and Neck Cancer Patients (NEOS)
- ClinicalTrials.gov ID
- NCT05294900
- Acronym / sponsor ID
- NEOS / 4-2022-0130
- Conditions
- Head and Neck Squamous Cell Carcinoma
- Keywords
- HNSCC, Neo-adjuvant chemotherapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 79 participants (actual)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- 26 May 2023 (actual)
- Primary completion
- 22 Oct 2025 (actual)
- Study completion
- 22 Oct 2025 (actual)
- First posted
- 24 Mar 2022 (actual)
- Results
- Posted 26 May 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- Objective: Primary objective: To evaluate the major pathologic response (mPR) of locally advanced head and neck cancer after paclitaxel and carboplatin-induction chemotherapy followed by surgery.
Secondary objective: To evaluate the efficacy and safety of induction chemotherapy. Outcome metrics: Local relapse rate (LRR), Relapse-free survival (RFS), Overall survival (OS), Adverse reactions according to CTCAE 5.0 Exploratory Purpose: To evaluate changes in circulating tumor cells (CTC) and immunodynamics before and after paclitaxel and carboplatin-induction chemotherapy through blood, biopsy specimens, and surgical specimen analysis.
- background :
- Chemoradiation (CRT) or chemotherapy (Induction Chemotherapy (IC) + CRT) after induction chemotherapy has been performed for locally advanced head and neck cancer that cannot be operated immediately or for organ function preservation. .
- The efficacy of induction chemotherapy before chemotherapy has been controversial because the results of several phase 3 clinical studies are inconsistent. At present, it is difficult to assert the superiority of either the addition of induction chemotherapy or radiation therapy alone, but in certain subgroups (advanced N stage such as N2c/N3) induction chemotherapy is a useful option to lower distant metastases. I can do it.
- As a result of the TAX324 clinical trial, when weekly carboplatin-based chemotherapy or surgery was performed after adjuvant Docetaxel + Cisplatin + 5FU chemotherapy, overall survival was improved compared to Cisplatin + 5FU (HR 0.7, p=0.0058), It resulted in improvement of institutional retention rate (3 year LFS: 52% vs 32%). However, it is difficult to apply this TPF therapy to all patients in actual clinical practice due to the toxicity (neutropenia, nephrotoxicity) and the limitation of anticancer radiation.
- In a retrospective study, in the case of adjuvant paclitaxel + carboplatin, there was no difference in progression-free survival compared to TPF (p=0.15), and there was no statistically significant decrease in the local recurrence rate (HR 0.27, p = 0.04). Confirmed.
- Therefore, in this study, when paclitaxel and carboplatin-induction chemotherapy followed by surgery and chemotherapy after surgery, compared to standard TPF-induced chemotherapy, it is expected that the clinical outcome will be improved with less toxicity.
- Hypothesis: Paclitaxel and carboplatin-induction chemotherapy followed by surgery, followed by chemo-radiation after surgery according to standard guidelines Compared with the existing standard treatment (TCF), improvement of clinical outcome with less toxicity
- Study procedure
- Induction chemotherapy Paclitaxel 175mg/m2 + Carboplatin AUC5 (calculated by Cockcroft - Gault formula) Combination therapy A total of 2 intravenous infusions every 3 weeks Surgery performed within 2-9 weeks after induction chemotherapy
- surgery The surgery in this study means a complete resection for the purpose of a complete cure, and aims for a minimally invasive surgery.
Detailed description
- Induction chemotherapy Paclitaxel 175mg/m2 + Carboplatin AUC5 (calculated by Cockcroft - Gault formula) Combination therapy A total of 2 intravenous infusions every 3 weeks"
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| paclitaxel/carboplatin | Experimental | Drug: paclitaxel/carboplatinpaclitaxel+carboplatin |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- A patient whose potentially surgical, teletransfer-free HNSCC of oral, hypodermic, occipital, and larynx has been tissue-confirmed Oral cancer of III-IV, laryngeal cancer, hypodermic cancer, HPV-negative head cancer II-III HPV positive head cancer
- A disease that can be measured, defined as a lesion that can be accurately measured pursuant to RECIST 1.1
- Where the candidate subject to the test prepares the consent of the person subject to the test after obtaining approval required by region before the commencement of any plan-related procedures, including screening evaluation
- Adult men and women over 20 years old at the time of participation in clinical trials
- Eastern Cancer Cooperation Research Group (Eastern Cooperative Oncology Group, ECOG) Activity Status 0 or 1
Key exclusion criteria (19 listed)
- Direct involvement in the planning and/or implementation of this clinical trial
- Patients with nasopharyngeal cancer
- A patient who has experienced previous treatment for head and neck cancer (including a history of radiation treatment)
- Patients who have participated in other clinical trials using clinical drugs within the past month
- A patient registered simultaneously in a clinical trial other than an observation (non-mediate) clinical trial or an intermediary clinical trial tracer
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 |
|---|---|---|
| paclitaxel/carboplatinInduction chemotherapy : total 2 cycle every 3weeks as below: * Paclitaxel 175mg/m2 * Carboplatin AUC5 | Drug | paclitaxel/carboplatin |
Primary outcome
Major Pathologic Response
Time frame: At the time of surgery following two cycles of neoadjuvant paclitaxel-carboplatin chemotherapy (approximately 6-9 weeks after treatment initiation).
Major Pathologic Response (MPR) was defined as ≤10% residual viable tumor cells in the resected primary tumor specimen following completion of two cycles of neoadjuvant paclitaxel-carboplatin chemotherapy. Pathologic evaluation was performed by two independent board-certified pathologists in a blinded manner. MPR reflects the extent of tumor regression induced by neoadjuvant therapy and serves as a key indicator of treatment efficacy in resectable head and neck squamous cell carcinoma.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 May 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing paclitaxel/carboplatin in people with Head and Neck Squamous Cell Carcinoma, run by Yonsei University at 1 site in South Korea.
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 16 inclusion and 19 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: finished, as of the sponsor's last update on 26 May 2026. 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 South Korea. 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?
Yes. Results are posted in the registry (first posted 26 May 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Major Pathologic Response (time frame: At the time of surgery following two cycles of neoadjuvant paclitaxel-carboplatin chemotherapy (approximately 6-9 weeks after treatment initiation).). 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 26 May 2026.