Squamous Cell Cancer of Head and Neck (SCCHN)Phase 3NCT07125755
Comparing Postoperative Adjuvant Cisplatin Concurrent Chemoradiotherapy With Adjuvant Radiotherapy Alone for Intermediate-risk Head and Neck Squamous Cell Carcinoma
A Phase 3 study testing Cisplatin in people with Squamous Cell Cancer of Head and Neck (SCCHN), run by Sun Yat-sen University at 7 sites in China.
Trial summary
The main objective of this trial was to determine the value of concurrent chemoradiotherapy for Intermediate-risk head and neck squamous cell carcinoma Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Squamous Cell Cancer of Head and Neck (SCCHN)
- What is being tested?
- Cisplatin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 386 participants
- Where
- 7 sitesChina
- Study dates
- 15 Aug 2025to 15 Aug 2031
- Phase
- Phase 3
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The pathological type is head and neck squamous cell carcinoma
- Stages
- Radical surgery has been performed, and there are intermediary-risk factors (pT3/pT4, pN2/pN3, positive lymph nodes in the cervical IV/V region of oral cancer, nerve invasion, and vascular invasion).
- No evidence of distant metastasis (M0).
- Functional status: Karnofsky scale (KPS) > 70.
- Normal bone marrow function:
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- white blood cell count > 4×109/L
- hemoglobin > 120g/L in males, 110g/L in females
- platelet count > 100×109/L
- Normal liver function:
- alanine aminotransferase (ALT), aspartate aminotransferase (AST) < 1.5 times the upper limit of normal (ULN)
- alkaline phosphatase (ALP) < 2.5×ULN
- bilirubin < ULN.
- Normal renal function: creatinine clearance > 60 ml/min.
- Patients must be informed of the basic contents of this study and sign informed consent.
Who cannot join
- Age >70 years or <18 years.
- Treatment is palliative.
- Previous chemotherapy (except induction chemotherapy prior to surgery).
- Previous radiation therapy.
- Women who are pregnant or breastfeeding
- Previous history of malignant tumor.
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- With other serious medical conditions that may pose a greater risk or affect compliance with the test. Examples include:
- unstable heart disease that requires treatment
- kidney disease
- chronic hepatitis
- poorly controlled diabetes (fasting blood glucose > 1.5×ULN)
- mental illness.
Trial locations and contacts
7 sites in 1 country. Contact the study team or a site near you to ask about taking part.
7 sites in 1 country
China7 sites, 7 recruiting
- Recruiting
Hunan Cancer Hospital
Changsha, Hunan
Bei Yang, M.D, +8673113507403512
- Recruiting
Xiangya Hospital, Central South University
Changsha, Hunan
Haijun Wu, M.D, +8673113975110101
- Recruiting
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, 523000
Lei Chen, M.D, +86-20-87343096, chenlei@sysucc.org.cn
- Recruiting
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, 523000
ling Ye, M.D, +8618666080933, 32600972@qq.com
- Recruiting
Affiliated Hospital of Guilin Medical College
Guilin, Guangxi
Wei Jiang, M.D, +8677313788561863
- Recruiting
Jiangsu Cancer Hospital
Nanjing, Jiangsu
Lirong Wu, M.D, +862513701588737
- Recruiting
Hainan General Hospital
Sanya, Hainan
Shiping Yang, M.D, +86 18976460313, shipingyang1982@163.com
About this study
Official title: A Prospective, Multicenter, Randomized Controlled Phase 3 Clinical Trial Comparing Postoperative Adjuvant Cisplatin Concurrent Chemoradiotherapy With Adjuvant Radiotherapy Alone for Intermediate-risk Head and Neck Squamous Cell Carcinoma
The main objective of this trial was to determine the value of concurrent chemoradiotherapy for Intermediate-risk head and neck squamous cell carcinoma
- Being tested
- Cisplatin
- Keywords
- Concurrent chemoradiotherapy, Cisplatin, postoperative head and neck squamous cell carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CisplatinDrug
Concurrent Cisplatin chemotherapy (100 mg/m2 intravenous injection,once every 3 weeks, twice in total, on days 1 and 22) will be given plus intensity modulated radiotherapy
| Study group | Role | What they receive |
|---|---|---|
| 2 courses of cisplatin chemoradiotherapy arm | Experimental | Patients will receive intensity modulated radiotherapy (total dose: > 66 Gy, split dose: 2-2.2 Gy/ time, once a day, 5 times a week) plus concurrent Cisplatin chemotherapy (100 mg/m2 intravenous injection,once every 3 weeks, twice in total, on days 1 and 22). Receives: Drug: Cisplatin |
| Postoperative adjuvant radiotherapy alone | No intervention | Patients will receive intensity modulated radiotherapy (total dose: > 66 Gy, split dose: 2-2.2 Gy/ time, once a day, 5 times a week) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Failure-free survival (FFS)
calculated from enrolment to the date of locoregional recurrence,distant metastasis,or death from any cause, whichever occurred first.
Measured: 3 years
Secondary outcomes (4)
Overall survival (OS)
calculated from enrolment to the date of death from any cause.
Measured: 3 years
Distant metastasis-free survival(DMFS)
calculated from enrolment to the date of first distant metastasis.
Measured: 3 years
locoregional recurrence-free survival (LRRFS)
calculated from enrolment to the date of locoregional persistence or 1st locoregional recurrence.
Measured: 3 years
Quality of life (QoL)
The change of QoL from randomization to the start of radiotherapy,the end of radiotherapy,13-16 weeks after radiotherapy,2 years and 3 years after randomization. The EORTC QoL questionnaire-C30(EORTC quality of life questionnaire-C30#version 3.0 will be used. This questionnaire comprises 30 questions,24 of which are aggregated into nine multi- question scales,that is,five functioning scales (e.g.,physical),three symptom scales (e.g.,fatigue)and one global health status scale. The remaining six single-question (e.g.,dyspnoea)scales assess symptoms. These 15 scales will be scored according to the official Scoring Manual.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2025
- Study start15 Aug 2025
- Primary completion15 Aug 2028 (estimated)
- Study completion15 Aug 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Squamous Cell Cancer of Head and Neck (SCCHN)Studies of the same condition, open and under way.
- More trials run by Sun Yat-sen 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 386 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lei Chen, Sun Yat-sen University
- Investigators
- Lei Chen Principal Investigator, M.D, Principal investigator, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07125755
- Sponsor's protocol ID
- SL-B2025-367-02
- Status last verified
- Mar 2026
- First submitted
- 10 Aug 2025
- Last updated
- 23 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- 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 23 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multicenter, Randomized Controlled Phase 3 Clinical Trial Comparing Postoperative Adjuvant Cisplatin Concurrent Chemoradiotherapy With Adjuvant Radiotherapy Alone for Intermediate-risk Head and Neck Squamous Cell Carcinoma
- ClinicalTrials.gov ID
- NCT07125755
- Acronym / sponsor ID
- SL-B2025-367-02
- Keywords
- Concurrent chemoradiotherapy, Cisplatin, postoperative head and neck squamous cell carcinoma
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 386 participants (estimated)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- 15 Aug 2025 (actual)
- Primary completion
- 15 Aug 2028 (estimated)
- Study completion
- 15 Aug 2031 (estimated)
- First posted
- 15 Aug 2025 (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.
The main objective of this trial was to determine the value of concurrent chemoradiotherapy for Intermediate-risk head and neck squamous cell carcinoma
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 2 courses of cisplatin chemoradiotherapy arm | Experimental | Drug: CisplatinPatients will receive intensity modulated radiotherapy (total dose: > 66 Gy, split dose: 2-2.2 Gy/ time, once a day, 5 times a week) plus concurrent Cisplatin chemotherapy (100 mg/m2 intravenous injection,once every 3 weeks, twice in total, on days 1 and 22). |
| Postoperative adjuvant radiotherapy alone | No intervention | –Patients will receive intensity modulated radiotherapy (total dose: > 66 Gy, split dose: 2-2.2 Gy/ time, once a day, 5 times a week) |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- The pathological type is head and neck squamous cell carcinoma
- Stages
- Radical surgery has been performed, and there are intermediary-risk factors (pT3/pT4, pN2/pN3, positive lymph nodes in the cervical IV/V region of oral cancer, nerve invasion, and vascular invasion).
- No evidence of distant metastasis (M0).
- Functional status: Karnofsky scale (KPS) > 70.
Key exclusion criteria (12 listed)
- Age >70 years or <18 years.
- Treatment is palliative.
- Previous chemotherapy (except induction chemotherapy prior to surgery).
- Previous radiation therapy.
- Women who are pregnant or breastfeeding
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 |
|---|---|---|
| CisplatinConcurrent Cisplatin chemotherapy (100 mg/m2 intravenous injection,once every 3 weeks, twice in total, on days 1 and 22) will be given plus intensity modulated radiotherapy | Drug | 2 courses of cisplatin chemoradiotherapy arm |
Primary outcome
Failure-free survival (FFS)
Time frame: 3 years
calculated from enrolment to the date of locoregional recurrence,distant metastasis,or death from any cause, whichever occurred first.
4 secondary outcomes
Overall survival (OS)
Time frame: 3 years
Distant metastasis-free survival(DMFS)
Time frame: 3 years
locoregional recurrence-free survival (LRRFS)
Time frame: 3 years
Quality of life (QoL)
Time frame: 3 years
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 23 Mar 2026.
- 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.
Lei Chen Principal Investigator, M.D principal investigator
Sun Yat-sen University
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Cisplatin in people with Squamous Cell Cancer of Head and Neck (SCCHN), run by Sun Yat-sen University at 7 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 15 inclusion and 12 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: looking for participants now, as of the sponsor's last update on 23 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Lei Chen, M.D (+862013570051477, chenlei@sysucc.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Failure-free survival (FFS) (time frame: 3 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 23 Mar 2026.