NCT06492460RecruitingPhase 3
2 Courses of Concurrent Cisplatin Chemoradiotherapy After Surgery for High-risk Head and Neck Squamous Cell Carcinoma
A Multicenter, Randomized Controlled, Non-inferior Phase 3 Clinical Trial of 2 Courses of Concurrent Cisplatin Chemoradiotherapy Versus 3 Courses After Surgery for High-risk Head and Neck Squamous Cell Carcinoma
Source: ClinicalTrials.gov · Last updated 14 Aug 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
The main objective of this trial was to determine the value of 2 courses of cisplatin concurrent chemotherapy in postoperative adjuvant radiotherapy for high-risk head and neck squamous cell carcinoma.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 422 (estimated)
- First submitted
- 2 Jul 2024
- Start date
- 20 Sept 2024
- Primary completion date
- 20 Sept 2029
- Lead sponsor
- Sun Yat-sen University
- Diseases
- Head and neck cancer
- NCT number
- NCT06492460
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 422
- From 20 Sept 2024 to the primary completion date, 20 Sept 2029
- 5 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Previous chemotherapy (except induction chemotherapy prior to surgery).
- Previous radiation therapy.
Other illness
- Previous history of malignant tumor.
- 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
- mental illness.
Lab values
- poorly controlled diabetes (fasting blood glucose \> 1.5×ULN)
Age
- Age \>70 years or \<18 years.
Other
- Treatment is palliative.
- Women who are pregnant or breastfeeding
Who the study is looking for
- The pathological type is head and neck squamous cell carcinoma
- Stages III and IV
- Radical surgery has been performed with high risk factors (one of below)
- extracapsular invasion of cervical metastatic lymph nodes
- positive incisional margin or inadequate incisional margin safety distance
- No evidence of distant metastasis (M0).
- Functional status: Karnofsky scale (KPS) \> 70.
- Normal bone marrow function:
- 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.
Age in the registry: 18 years to 70 years · Sex: All · Does not accept healthy volunteers
Sites (5)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Hunan Cancer Hospital Coordinator of this site? Confirm its status | Changsha | China | Not yet recruiting |
| Xiangya Hospital Central South University Coordinator of this site? Confirm its status | Changsha | China | Not yet recruiting |
| Sun Yat-sen University Cancer Center Coordinator of this site? Confirm its status | Guangzhou | China | Recruiting |
| Affiliated Hospital of Guilin Medical College Coordinator of this site? Confirm its status | Guilin | China | Not yet recruiting |
| Jiangsu Cancer Hospital Coordinator of this site? Confirm its status | Nanjing | China | Not yet recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.